InsomniaNCT03823456
Self-acupressure for Cancer-related Symptom Cluster of Insomnia, Depression, and Anxiety: a Feasibility Study
A study testing Self-acupressure in people with Insomnia and Anxiety, run by The Hong Kong Polytechnic University at 2 sites in Vietnam.
Trial summary
Aim: To assess the acceptability and make estimations about the effectiveness of using self-acupressure to manage insomnia, depression, and anxiety in cancer patients undergoing chemotherapy. Study design: three-arms randomized sham-controlled trial. Read more about this study
- Who is it for?
- Ages 20 to 84 years
- Conditions the study is for
- Insomnia, Anxiety, Depression
- What is being tested?
- Self-acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 2 sitesVietnam
- Study dates
- 4 Dec 2018to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing chemotherapy currently.
- Able to read and write Vietnamese (to complete the questionnaires and provide informed consent).
- Have Karnofsky score ≥ 80 (to be able to practice self-acupressure).
- Have Insomnia Severity Index score ≥ 11
- Have Anxiety score measured by HADS ≥ 8 and Depression score measured by HADS ≥ 8
Who cannot join
- Are unable to understand or cooperate with study procedures.
- Are receiving other cancer treatments (e.g., radiotherapy, hormonal therapy) at the same time as receiving chemotherapy and during the period of their involvement in the trial.
- Are participating in other research studies which may have interacted with the current trial or affect insomnia, depression, anxiety perception.
- Have difficulties or are unable to practice self-acupressure by themselves.
- Are receiving insomnia or depression/anxiety treatment currently.
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites, 2 recruiting
- Recruiting
Vietnam National Cancer Institution
Hanoi, Ha Dong, 10000
Tuyen T Nguyen, BSN, 0386097976, tuyennguyenbn8689@gmail.com
Anh H Vu, MPH, 0982708203, hoanganhvu.sc@gmail.com
- Not yet recruiting
Hanoi Oncology Hospital
Hanoi, Hai Ba Trung, 10000
Quyen Ngo, MD, 0983187905, quyen.hoh@gmail.com
Van Tran, BSN, 975669157, huongxh@gmail.com
About this study
Official title: Self-acupressure for Cancer-related Symptom Cluster of Insomnia, Depression, and Anxiety in Cancer Patients: a Feasibility Randomized Controlled Trial
Aim: To assess the acceptability and make estimations about the effectiveness of using self-acupressure to manage insomnia, depression, and anxiety in cancer patients undergoing chemotherapy.
Study design: three-arms randomized sham-controlled trial. Participants will be assigned to the true self-acupressure group, sham acupressure group, or enhanced standard care group, with a ratio of 1:1:1 using block randomize.
Read more
Participants: patients receiving chemotherapy. 114 patients will be recruited to the study.
Inclusion criteria: Undergoing chemotherapy currently, Age 20 - 84 years' old, able to read and write Vietnamese, Karnofsky score ≥ 80, Insomnia Severity Index (ISI) score ≥ 11, Anxiety score measured by The Hospital Anxiety and Depression Scale (HADS) ≥ 8 and Depression score measured by HADS ≥ 8
Exclusion criteria:
Patients are excluded from the trial if they are unable to understand or cooperate with study procedures, receiving other cancer treatments (e.g., radiotherapy, hormonal therapy) at the same time as receiving chemotherapy and during the period of their involvement in the trial, participating in other research studies which may have interacted with the current trial or affect insomnia, depression, anxiety perception, having difficulties or are unable to practice self-acupressure by themselves, are receiving insomnia or depression/anxiety treatment currently.
Interventions Self-administered acupressure training section Participants in the true or sham self-acupressure groups will receive a self-administered acupressure training section based on their group assignment. Then, they will be requested to practice acupressure at home for 4 weeks.
Patient leaflet All of the participants in three groups will receive a patient leaflet with tips to manage insomnia, depression, and anxiety.
Weekly telephone reminder will be made to follow-up participants in all groups. Outcome measurement The recruitment rate, consent rate, refusal rate, attrition rate, adherence rate will be calculated. The acceptability of the intervention will be measured by the Intervention Rating Profile - 15. The ISI, The HADS, and The Functional Assessment of Cancer Therapy-General will be used to evaluate the effects of self-acupressure on the severity of insomnia, depression, anxiety. Others sleep parameters and adverse events associated with self-acupressure will be recorded.
Read the detailed description
- Background Major treatments for cancer include surgery, radiotherapy, and chemotherapy improve patient's survival but also can exert a significant psychosocial and physical impact on patients by producing a variety of unpleasant symptoms. Applying the concept of identification symptom cluster by the correlation between symptoms, different sleep-related symptom clusters among cancer patient have been identified across studies such as: fatigue, depression and insomnia; pain, fatigue and or pain, depression, and insomnia. However, the correlation between insomnia and other symptoms was not fully explored. Therefore, to identify current evidence of sleep-related symptom cluster, we have conducted a cross-sectional survey among 213 cancer patients undergoing chemotherapy in Vietnam. The results indicated that among participants, a symptom cluster of insomnia, depression, and anxiety was evident. Based on the literature review, acupressure can potentially reduce insomnia as well as other symptoms in cancer patients. However, the use of acupressure in specific self-acupressure in managing symptom cluster of insomnia, depression, and anxiety is unknown but worthy for further research.
- Methodologies of the study 2.1. The development of the self-acupressure protocols for managing insomnia, depression, and anxiety To distinguish the specific treatment (true) effects of acupressure treatment from the nonspecific treatment (placebo) effects, a true self-acupressure protocol and a sham self-acupressure protocol were being developed accordingly. The true acupressure protocol was developed based on the theory of Traditional Chinese Medicine (TCM), available systematic reviews are used for selecting acupoints and choosing treatment dose, and World Health Organization (WHO) standard acupuncture point location guidelines were used to locate the acupoint and technique for self-acupressure.
True and sham acupressure protocol These acupoints are being selected for the true acupressure protocol Baihui (GV20), Yintang (EX-HN3), Fengchi (GB20), Neiguan (PC6), Shenmen (HT7), Taichong (LR3) These points are being selected for the sham acupressure protocol SA 1: Base of metacarpal bone of the right middle finger SA 2 2 cm superior to the end of the right eyebrow SA 3 Mastoid bone SA 4 Head of ulnar styloid SA 5 Base of metacarpal bone of the index finger SA 6 Medial malleolus Duration of each section (true and sham acupressure): 24 minutes (3 mins per point) Duration of whole treatment (true and sham acupressure): 4 weeks (28 days) Time for practice self-acupressure: Before bedtime (final activities of the day, after practicing acupressure the participants should attempt to sleep) The suitability of true and sham self-acupressure protocols had been validated by a panel of six TCM experts from Hong Kong and Vietnam.
2.2. Methods of the feasibility study 2.2.1. The study design A feasibility study with three-arms randomized sham-controlled trial will be set up. The three arms are the true acupressure group, the sham acupressure group, and the enhanced standard care group.
2.2.2. Sample size Applying the rule of thumb, 30 subjects will be recruited for each study groups. The potential drop-out rate of 20% is used to calculate the total sample size for the feasibility study. Therefore, the sample size will be set at 114 patients with 38 patients per group.
2.2.3. Settings The study will be conducted in the Vietnam National Cancer Institute and Hanoi Oncology Hospital. All of them are located in Hanoi, the capital of Vietnam.
2.2.4. Randomization, allocation concealment, and blinding 2.2.4.1. Randomization and allocation concealment. Block randomization will be. 114 participants will be randomized into three study groups in a block of six participants. A randomization table will be computer generated by using the online randomizer. It will be prepared and kept by a researcher who does not involve in any research process. After recruiting enough participants for a block, the main researcher will send the list of participants' name to the randomization table keeper. The randomization table keeper will then randomly assign participants into trial groups based on the prepared randomization table and email the group assignments to the main researcher.
2.2.4.2. Blinding Participants randomized in the standard care group will know their group assignment, but participants randomize to the true and sham self-acupressure group will not know whether they receive true or sham self-acupressure treatment. Nevertheless, the outcomes of the study are all self-reported instruments, so the participants themselves could be viewed as "outcome assessors". Therefore, participants and "outcome assessors" located in the true or sham self-acupressure group will be blinded on the treatment allocation.
2.2.5. Study procedures Participants from five chemotherapy units will be recruited to the study (two chemotherapy units in hospital A, and three from hospital B). On the first day patients admitted to the hospital, during the health assessment, nurses will ask the patients to rate the severity of insomnia, depression and anxiety that they experience during the previous month. Each of the symptoms will be measured by separate Numerical Analog Scales (NAS). NAS is an 11-point scales with 0 means "not present" and 10 means "worst possible". If the patients rate 4 or above for their insomnia, depression, and anxiety nurses will inform the main researcher and introduce the potential patient to the main researcher. The main researcher will introduce the study in detail to potential participants and give them the information sheet and inform consent form. After signing the consent form, researchers will collect the demographic data of participants and instruct participants to complete the baseline assessment. After the participants complete the baseline assessment, the main researcher will summarize the result and if the participants eligible for the trial they will be instructed how to complete the seven days sleep diary after they discharge from the hospital. Afterward, participants will be randomly assigned to one of the following groups: the true self-acupressure group (TSA), the sham self-acupressure group (SSA) and enhanced standard care group (ESC).
Participants in the true self-acupressure group or sham self-acupressure group Participants in these group will either receive a true self-acupressure or sham acupressure training section based on their group assignment. Participants will be requested to practice acupressure at home for four weeks after they complete the sleep diary baseline assessment (a telephone reminder will be made). During the four weeks treatment, participants will receive a weekly phone call from researchers for encouraging to practice acupressure and answer inquiries may have. During this period, participant will be requested to complete Self-acupressure record form every day. After four weeks treatment, participants will be asked to complete and send back all the post-intervention assessing questionnaire to research by express service. A short-term follow up will be then carried out in four weeks to assess the persistence effect of acupressure on the symptoms outcome. During this time, the patient will not practice acupressure at home. By the end of follow up time, researchers will make a telephone reminder to participants and ask them to complete and send back all the follow-up assessment questionnaire to the main research by express service. 200,000 Vietnam dong (vnd) will be given to participants for the express service charge by the end of the follow-up time.
Participants in the enhanced standard control group Participants in the enhanced standard control group will receive the leaflet with tips to manage insomnia, depression, and anxiety. Weekly telephone reminder will also be made in four weeks. By the end of week fourth, participants in this group will be requested to complete post-intervention assessment and send back to research by post. A short-term follow up will be then carried out in 4 weeks. During the follow-up period, participants receive no weekly telephone reminder. By the end of follow up time, researchers will make a telephone reminder to participants and ask them to complete and send back all the follow-up assessment questionnaire to research by express service. 200,000 vnd will be given to participants for the express service charge by the end of the follow-up time.
2.2.5.1. Training of Subject recruitment Five nurses will be recruited for subject recruitment. Nurses who work in potential chemotherapy units with at least one year of experience in working with cancer patients will be recruited. They will receive a training section conducted by the main researcher on how to recruite participants.
2.2.5.2. Training of the interventionists Four nurses will be trained to become interventionists for the study (2 nurses/hospital). Nurses who work in potential hospitals with at least two years of experience in working with cancer patients will be recruited as interventionists of the study. A one hours training section (TOT section) will be delivered by the main researcher and a TCM professional.
2.2.5.3. Training of the participants in the true self-acupressure group and sham self-acupressure group: Participants locate in these groups will receive education section. The training will be conducted in a group of two to four participants in 45 minutes. The self-acupressure training section will take place in the consultation room in the chemotherapy unit. In the education section, interventionists will instruct the participants how to locate and stimulate acupoint following the acupressure protocols. After giving instruction and time for participants to practice, interventionists checksthe patient's mastery of self-acupressure technique by using the Acupressure Skill Check form for participants. If the participant fails to identify the acupoint or stimulate the acupoint wrongly, the interventionist will then correct them. By the end of the education section, a patient booklet includes step by step guideline with images-illustrating acupressure protocol will be given to participants.
2.3. Ethical consideration The study had gained ethical approval from The Hong Kong Polytechnic University and Vietnamese Ministry of Health. This study has followed the ethical principles for research that involves human subjects which are: autonomy, beneficence, non-maleficence, and confidentiality).
2.4. Data Analysis Data will be checked for normality, outliers, and missing data. Intention to treat principle is adapted for analyzing the result of the pilot study which use the "last value carried out forward" approach to replace missing data. Descriptive statistics will be used to analyze the sample characteristics, demographics, and data related to the intervention feasibility, acceptability and adverse event of acupressure. Baseline differences among the three groups will be compared by chi-square test and repeated measure ANOVA. In case the chi-square test is not appropriated because of low cell counts (≤ 5), it will be replaced by Fisher's exact test. The effect size will be calculated by Cohen d based on the mean difference between baseline and end of the treatment period for each symptom and the cluster of insomnia, depression, and anxiety in the true self-acupressure group and sham acupressure group. The significance level is set at 0.05. IBM SPSS 20.0 software will be used for data analysis.
- Conditions
- Insomnia, Anxiety, Depression
- Being tested
- Self-acupressure, Sham Self-acupressure
- Keywords
- acupressure, insomnia, anxiety, depression, symptom cluster
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Depression, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-acupressureOther
We teach participants how to using self-acupressure to manage insomnia, depression, and anxiety. Six acupoints are included in our acupressure protocol which are Baihui, Yintang, Fengchi, Neiguan, Shenmen, and Taichong. Participants are requested to stimulate each acupoint in 3 minutes once a day (at night time before going to bed) in 28 days (4 weeks). During the four weeks treatment, participants will receive a weekly phone call follow up to remind them practice self-acupressure at home. Participant also receives a patient leaflet with 10 tips heil to manage insomnia, depression, and anxiety. These tips include some basic sleep hygiene rules and tips to manage anxiety and depression adapted from Anxiety and Depression Association of American.
Sham Self-acupressureOther
We using a sham acupressure protocol to teach participants in this group. Six sham acupoints are included in the protocol. The sham acupoints are located 2-5cm away from the true acupoints. Participants are requested to stimulate each sham acupoint in 3 minutes once a day (at night time before going to bed) in 28 days (4 weeks). During the four weeks treatment, participants will receive a weekly phone call follow up to remind them practice self-acupressure at home. Participant also receives a patient leaflet with 10 tips heil to manage insomnia, depression, and anxiety. These tips include some basic sleep hygiene rules and tips to manage anxiety and depression adapted from the Anxiety and Depression Association of American.
| Study group | Role | What they receive |
|---|---|---|
| True self-acupressure group | Experimental | True self-acupressure group [Enhanced standard care + True self-acupressure intervention protocol]:
Participants in this group will practice the four-week acupressure protocol plus standard care. When participants admit hospital to receive chemotherapy treatment, they will receive a self-acupressure training section. Participants will be requested to practice acupressure at home once a day at night time (before going to bed) for four weeks. During the four weeks treatment, participants will receive a weekly phone call follow up from researchers. Receives: Other: Self-acupressure |
| Sham self-acupressure group | Placebo comparator | Patients in this group will practice the four weeks sham self-acupressure protocol plus standard care. When participants admit hospital to receive chemotherapy treatment, they will receive a self-acupressure training section. Participants will be requested to practice sham acupressure at home once a day at night time (before going to bed) for four weeks. During the four weeks treatment, participants will receive a weekly follow up phone call from researchers Receives: Other: Sham Self-acupressure |
| Enhanced standard care group | No intervention | The standard care for cancer patients undergoing chemotherapy includes health assessment, regular health advice regarding symptoms that patients report and nutrition advice during taking chemotherapy treatment. Apart from the standard care, we provide participants a leaflet with 10 recommendations which help participants manage insomnia, depression, and anxiety. By providing this leaflet, we slightly enhance the standard care but do not contaminate the effective of the intervention since these tips are basic and participants can easily read about them on the internet or newspaper. In addition, to minimize the bias caused by contacting between interventionist and participants, we also provide participants in the enhanced standard care group weekly follow up phone call in four weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eligible participants
The recruitment rate is calculated by dividing the number of the eligible participant by the total number of screened participants
Measured: up to 15 weeks
Number of patients who refuse to participant in the study
The refusal rate is calculated by dividing the number of participants who do not participate in the study by the total number of eligible participants
Measured: up to 15 weeks
Acceptability score of the intervention measured by participants
The acceptability score of the intervention will be measured by The Intervention Rating Profile - 15 (Martens, Witt, Elliott, \& Darveaux, 1985). The Intervention Rating Profile - 15 (IRP-15) consists of 15 items; each item is rated on a six-point Likert scale ranging from one (Strongly disagree) to six (Strongly agree). The higher score indicated higher acceptability of the intervention. The scale had been validated, translated into Vietnamese with high reliability (Cronbach's α = 0.89) (Nguyen, Alexander, \& Yates, 2018)
Measured: One month after participants enroll the trial
Acceptability of study procedures measured by participants
The attrition rate will be calculated by the number of participants who decide to discontinue the study and the number of participants who are lost to contact during the study period. Reason for dropping out and lost to contact will be recorded
Measured: One month after participants enroll the trial
Adverse events associated with self-acupressure reported by participants
Participants will be requested to report potential adverse events related to acupressure in the "Self-Acupressure Record Form."
Measured: One month after participants enroll the trial
Change from baseline in insomnia score on Insomnia Severity Index at post intevention and after follow-up time
The Insomnia Severity Index (ISI) is used to measure insomnia severity among participants. The ISI is a self-reported questionnaire consisting of seven items to assess the nature, severity, and impact of insomnia. A score of 7 items indicates the insomnia severity, the min score is 0 and the maximum score is 28, the higher score indicates worse insomnia severity. The insomnia severity is interpreted as follows: moderate insomnia (ISI score of 15 to 21), severe insomnia (ISI score of 22 to 28). This instrument had been validated translated into Vietnamese previously (Long, Thanasilp, \& Thato, 2016) and was being used in our previous study with high reliability (Cronbach's α = 0.92).
Measured: Change from baseline insomnia severity at one month and two months
Change of participants' sleep parameter in sleep diary from baseline at post intervention and after follow-up time
A sleep diary is used to measure sleep parameters. The participant will be requested to complete a one-week sleep diary before starting practice acupressure, after the treatment period ends, and after. The sleep diary is used to measure these sleep parameters: Total Sleep time (minute), total time in bed (minute), the number of night awaken after sleep onset and sleep efficiency.
Measured: Change from baseline at one month and two months
Change from baseline in depression and anxiety scoreon Hospital Depression and Anxiety Scale at post intevention and after follow-up time
The Hospital Anxiety and Depression Scale (HADS) was developed by Zigmond and Snaith (1983) to measure depression and anxiety among participants. This scale has 14 items, seven items measuring anxiety and seven items measuring depression over the past week. The total depression/anxiety score range from 0 to 28 with the higher total score indicates worse depression/anxiety. This instrument had been translated into Vietnamese previously (Long et al., 2016) and was used in our previous study with the Cronbach's alpha for the scale was 0.87, and for anxiety, subscale was 0.86, and for depression, subscale was 0.76.
Measured: Change from baseline depression and anxiety severity at one month and two months
Change from baseline in symptom cluster score on numerical analo scale from baseline at post intervetion and after follow-up time
Separate numerical analog scales (NAS) for each symptom will be used to measure the severity of the whole cluster in the previous month. The symptom severity score of each of symptom in the cluster will be measured by an 11-point scales with 0 means "not present" and 10 means "as bad as it could be." Symptom severity at the cluster level will be evaluated by the averaging symptom severity score of each symptom in the cluster.
Measured: Change from baseline symptom cluster severity at one month and two months
Change in participants'quality of life on the Functional Assessment of Cancer Therapy-General scale from baseline at post intervention and after follow-up time
The Functional Assessment of Cancer Therapy-General (FACT-G) is used in this study to assess the quality of life in participants. The questionnaire consists of 27 items each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). This scale measures four sub-scales: Physical well-being (PWB, 7 items); Social/family well-being (SWB, 7 items); Emotional well-being (EWB, 6 items) and Functional well-being (FWB, 7 items). The total score range from 0 to 108, questions are phrased so that higher numbers indicate a better health state. Each subscale is scored, and a total score for the FACT-G is obtained by adding each of the subscale scores. This instrument has been translated into Vietnamese by the Functional Assessment of Chronic Illness Therapy system and had been used in the previous study with the Cronbach's alpha for the scale was 0.89, and for Emotional well-being, subscales were 0.78, FWB = 0.82, PWB = 0.81 and for SWB was 0.82.
Measured: Change from baseline quality of life at one month and two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start4 Dec 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (64)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- True self-acupressure group \[Enhanced standard care + True self-acupressure\]: Participants will practice the four-week acupressure protocol plus standard care. During the four weeks treatment, participants will receive a weekly phone call follow up from researchers. Sham self-acupressure group \[Enhanced standard care + Sham self-acupressure\]: Patients will practice the four weeks sham self-acupressure protocol plus standard care. During the four weeks treatment, participants will receive a weekly follow up phone call from researchers. Enhanced standard care group The enhanced standard care in this study refers to standard care provided by the hospital includes health assessment, nutrition advice during taking chemotherapy treatment, hypnotics (Prescribe only where necessary by a doctor), and the enhanced care provided by the main researcher includes patient leaflet of tips on managing insomnia, depression, and anxiety; weekly follow-up phone call in four weeks.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huong TX Hoang, Study director, The Hong Kong Polytechnic UniversityAlex Molassiotis, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823456
- Sponsor's protocol ID
- HSEARS20180604004
- Status last verified
- Jan 2019
- First submitted
- 22 Jan 2019
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As required by ethical principals, we will not share IPD to other researchers in order to protect the participant's personal information.
Publications
Abedian Z, Eskandari L, Abdi H, Ebrahimzadeh S. The Effect of Acupressure on Sleep Quality in Menopausal Women: A Randomized Control Trial. Iran J Med Sci. 2015 Jul;40(4):328-34.
PubMed 26170519Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T; CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001 Apr 17;134(8):663-94. doi: 10.7326/0003-4819-134-8-200104170-00012.
PubMed 11304107Anderson KO, Getto CJ, Mendoza TR, Palmer SN, Wang XS, Reyes-Gibby CC, Cleeland CS. Fatigue and sleep disturbance in patients with cancer, patients with clinical depression, and community-dwelling adults. J Pain Symptom Manage. 2003 Apr;25(4):307-18. doi: 10.1016/s0885-3924(02)00682-6.
PubMed 12691682Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.
PubMed 15367063Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
PubMed 11832252Bokmand S, Flyger H. Acupuncture relieves menopausal discomfort in breast cancer patients: a prospective, double blinded, randomized study. Breast. 2013 Jun;22(3):320-3. doi: 10.1016/j.breast.2012.07.015. Epub 2012 Aug 18.
PubMed 22906948Bonnet MH, Arand DL. Sleepiness as measured by modified multiple sleep latency testing varies as a function of preceding activity. Sleep. 1998 Aug 1;21(5):477-83.
PubMed 9703587Buysse DJ, Ancoli-Israel S, Edinger JD, Lichstein KL, Morin CM. Recommendations for a standard research assessment of insomnia. Sleep. 2006 Sep;29(9):1155-73. doi: 10.1093/sleep/29.9.1155.
PubMed 17040003Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.
PubMed 22294820Cerrone R, Giani L, Galbiati B, Messina G, Casiraghi M, Proserpio E, Meregalli M, Trabattoni P, Lissoni P, Gardani G. Efficacy of HT 7 point acupressure stimulation in the treatment of insomnia in cancer patients and in patients suffering from disorders other than cancer. Minerva Med. 2008 Dec;99(6):535-7.
PubMed 19034252Choi TY, Kim JI, Lim HJ, Lee MS. Acupuncture for Managing Cancer-Related Insomnia: A Systematic Review of Randomized Clinical Trials. Integr Cancer Ther. 2017 Jun;16(2):135-146. doi: 10.1177/1534735416664172. Epub 2016 Aug 16.
PubMed 27531549Chung KF, Yeung WF, Yu YM, Yung KP, Zhang SP, Zhang ZJ, Wong MT, Lee WK, Chan LW. Acupuncture for residual insomnia associated with major depressive disorder: a placebo- and sham-controlled, subject- and assessor-blind, randomized trial. J Clin Psychiatry. 2015 Jun;76(6):e752-60. doi: 10.4088/JCP.14m09124.
PubMed 26132682Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
PubMed 18824488Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA. 2003 May 21;289(19):2554-9. doi: 10.1001/jama.289.19.2554.
PubMed 12759327Dowrick AS, Bhandari M. Ethical issues in the design of randomized trials: to sham or not to sham. J Bone Joint Surg Am. 2012 Jul 18;94 Suppl 1:7-10. doi: 10.2106/JBJS.L.00298.
PubMed 22810439
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-acupressure for Cancer-related Symptom Cluster of Insomnia, Depression, and Anxiety in Cancer Patients: a Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03823456
- Acronym / sponsor ID
- HSEARS20180604004
- Conditions
- Insomnia, Anxiety, Depression
- Keywords
- acupressure, insomnia, anxiety, depression, symptom cluster
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jul 2019 (estimated)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: To assess the acceptability and make estimations about the effectiveness of using self-acupressure to manage insomnia, depression, and anxiety in cancer patients undergoing chemotherapy.
Study design: three-arms randomized sham-controlled trial. Participants will be assigned to the true self-acupressure group, sham acupressure group, or enhanced standard care group, with a ratio of 1:1:1 using block randomize.
Participants: patients receiving chemotherapy. 114 patients will be recruited to the study.
Inclusion criteria: Undergoing chemotherapy currently, Age 20 - 84 years' old, able to read and write Vietnamese, Karnofsky score ≥ 80, Insomnia Severity Index (ISI) score ≥ 11, Anxiety score measured by The Hospital Anxiety and Depression Scale (HADS) ≥ 8 and Depression score measured by HADS ≥ 8
Exclusion criteria:
Patients are excluded from the trial if they are unable to understand or cooperate with study procedures, receiving other cancer treatments (e.g., radiotherapy, hormonal therapy) at the same time as receiving chemotherapy and during the period of their involvement in the trial, participating in other research studies which may have interacted with the current trial or affect insomnia, depression, anxiety perception, having difficulties or are unable to practice self-acupressure by themselves, are receiving insomnia or depression/anxiety treatment currently.
Interventions Self-administered acupressure training section Participants in the true or sham self-acupressure groups will receive a self-administered acupressure training section based on their group assignment. Then, they will be requested to practice acupressure at home for 4 weeks.
Patient leaflet All of the participants in three groups will receive a patient leaflet with tips to manage insomnia, depression, and anxiety.
Weekly telephone reminder will be made to follow-up participants in all groups. Outcome measurement The recruitment rate, consent rate, refusal rate, attrition rate, adherence rate will be calculated. The acceptability of the intervention will be measured by the Intervention Rating Profile - 15. The ISI, The HADS, and The Functional Assessment of Cancer Therapy-General will be used to evaluate the effects of self-acupressure on the severity of insomnia, depression, anxiety. Others sleep parameters and adverse events associated with self-acupressure will be recorded.
Detailed description
- Background Major treatments for cancer include surgery, radiotherapy, and chemotherapy improve patient's survival but also can exert a significant psychosocial and physical impact on patients by producing a variety of unpleasant symptoms. Applying the concept of identification symptom cluster by the correlation between symptoms, different sleep-related symptom clusters among cancer patient have been identified across studies such as: fatigue, depression and insomnia; pain, fatigue and or pain, depression, and insomnia. However, the correlation between insomnia and other symptoms was not fully explored. Therefore, to identify current evidence of sleep-related symptom cluster, we have conducted a cross-sectional survey among 213 cancer patients undergoing chemotherapy in Vietnam. The results indicated that among participants, a symptom cluster of insomnia, depression, and anxiety was evident. Based on the literature review, acupressure can potentially reduce insomnia as well as other symptoms in cancer patients. However, the use of acupressure in specific self-acupressure in managing symptom cluster of insomnia, depression, and anxiety is unknown but worthy for further research.
- Methodologies of the study 2.1. The development of the self-acupressure protocols for managing insomnia, depression, and anxiety To distinguish the specific treatment (true) effects of acupressure treatment from the nonspecific treatment (placebo) effects, a true self-acupressure protocol and a sham self-acupressure protocol were being developed accordingly. The true acupressure protocol was developed based on the theory of Traditional Chinese Medicine (TCM), available systematic reviews are used for selecting acupoints and choosing treatment dose, and World Health Organization (WHO) standard acupuncture point location guidelines were used to locate the acupoint and technique for self-acupressure.
True and sham acupressure protocol These acupoints are being selected for the true acupressure protocol Baihui (GV20), Yintang (EX-HN3), Fengchi (GB20), Neiguan (PC6), Shenmen (HT7), Taichong (LR3) These points are being selected for the sham acupressure protocol SA 1: Base of metacarpal bone of the right middle finger SA 2 2 cm superior to the end of the right eyebrow SA 3 Mastoid bone SA 4 Head of ulnar styloid SA 5 Base of metacarpal bone of the index finger SA 6 Medial malleolus Duration of each section (true and sham acupressure): 24 minutes (3 mins per point) Duration of whole treatment (true and sham acupressure): 4 weeks (28 days) Time for practice self-acupressure: Before bedtime (final activities of the day, after practicing acupressure the participants should attempt to sleep) The suitability of true and sham self-acupressure protocols had been validated by a panel of six TCM experts from Hong Kong and Vietnam.
2.2. Methods of the feasibility study 2.2.1. The study design A feasibility study with three-arms randomized sham-controlled trial will be set up. The three arms are the true acupressure group, the sham acupressure group, and the enhanced standard care group.
2.2.2. Sample size Applying the rule of thumb, 30 subjects will be recruited for each study groups. The potential drop-out rate of 20% is used to calculate the total sample size for the feasibility study. Therefore, the sample size will be set at 114 patients with 38 patients per group.
2.2.3. Settings The study will be conducted in the Vietnam National Cancer Institute and Hanoi Oncology Hospital. All of them are located in Hanoi, the capital of Vietnam.
2.2.4. Randomization, allocation concealment, and blinding 2.2.4.1. Randomization and allocation concealment. Block randomization will be. 114 participants will be randomized into three study groups in a block of six participants. A randomization table will be computer generated by using the online randomizer. It will be prepared and kept by a researcher who does not involve in any research process. After recruiting enough participants for a block, the main researcher will send the list of participants' name to the randomization table keeper. The randomization table keeper will then randomly assign participants into trial groups based on the prepared randomization table and email the group assignments to the main researcher.
2.2.4.2. Blinding Participants randomized in the standard care group will know their group assignment, but participants randomize to the true and sham self-acupressure group will not know whether they receive true or sham self-acupressure treatment. Nevertheless, the outcomes of the study are all self-reported instruments, so the participants themselves could be viewed as "outcome assessors". Therefore, participants and "outcome assessors" located in the true or sham self-acupressure group will be blinded on the treatment allocation.
2.2.5. Study procedures Participants from five chemotherapy units will be recruited to the study (two chemotherapy units in hospital A, and three from hospital B). On the first day patients admitted to the hospital, during the health assessment, nurses will ask the patients to rate the severity of insomnia, depression and anxiety that they experience during the previous month. Each of the symptoms will be measured by separate Numerical Analog Scales (NAS). NAS is an 11-point scales with 0 means "not present" and 10 means "worst possible". If the patients rate 4 or above for their insomnia, depression, and anxiety nurses will inform the main researcher and introduce the potential patient to the main researcher. The main researcher will introduce the study in detail to potential participants and give them the information sheet and inform consent form. After signing the consent form, researchers will collect the demographic data of participants and instruct participants to complete the baseline assessment. After the participants complete the baseline assessment, the main researcher will summarize the result and if the participants eligible for the trial they will be instructed how to complete the seven days sleep diary after they discharge from the hospital. Afterward, participants will be randomly assigned to one of the following groups: the true self-acupressure group (TSA), the sham self-acupressure group (SSA) and enhanced standard care group (ESC).
Participants in the true self-acupressure group or sham self-acupressure group Participants in these group will either receive a true self-acupressure or sham acupressure training section based on their group assignment. Participants will be requested to practice acupressure at home for four weeks after they complete the sleep diary baseline assessment (a telephone reminder will be made). During the four weeks treatment, participants will receive a weekly phone call from researchers for encouraging to practice acupressure and answer inquiries may have. During this period, participant will be requested to complete Self-acupressure record form every day. After four weeks treatment, participants will be asked to complete and send back all the post-intervention assessing questionnaire to research by express service. A short-term follow up will be then carried out in four weeks to assess the persistence effect of acupressure on the symptoms outcome. During this time, the patient will not practice acupressure at home. By the end of follow up time, researchers will make a telephone reminder to participants and ask them to complete and send back all the follow-up assessment questionnaire to the main research by express service. 200,000 Vietnam dong (vnd) will be given to participants for the express service charge by the end of the follow-up time.
Participants in the enhanced standard control group Participants in the enhanced standard control group will receive the leaflet with tips to manage insomnia, depression, and anxiety. Weekly telephone reminder will also be made in four weeks. By the end of week fourth, participants in this group will be requested to complete post-intervention assessment and send back to research by post. A short-term follow up will be then carried out in 4 weeks. During the follow-up period, participants receive no weekly telephone reminder. By the end of follow up time, researchers will make a telephone reminder to participants and ask them to complete and send back all the follow-up assessment questionnaire to research by express service. 200,000 vnd will be given to participants for the express service charge by the end of the follow-up time.
2.2.5.1. Training of Subject recruitment Five nurses will be recruited for subject recruitment. Nurses who work in potential chemotherapy units with at least one year of experience in working with cancer patients will be recruited. They will receive a training section conducted by the main researcher on how to recruite participants.
2.2.5.2. Training of the interventionists Four nurses will be trained to become interventionists for the study (2 nurses/hospital). Nurses who work in potential hospitals with at least two years of experience in working with cancer patients will be recruited as interventionists of the study. A one hours training section (TOT section) will be delivered by the main researcher and a TCM professional.
2.2.5.3. Training of the participants in the true self-acupressure group and sham self-acupressure group: Participants locate in these groups will receive education section. The training will be conducted in a group of two to four participants in 45 minutes. The self-acupressure training section will take place in the consultation room in the chemotherapy unit. In the education section, interventionists will instruct the participants how to locate and stimulate acupoint following the acupressure protocols. After giving instruction and time for participants to practice, interventionists checksthe patient's mastery of self-acupressure technique by using the Acupressure Skill Check form for participants. If the participant fails to identify the acupoint or stimulate the acupoint wrongly, the interventionist will then correct them. By the end of the education section, a patient booklet includes step by step guideline with images-illustrating acupressure protocol will be given to participants.
2.3. Ethical consideration The study had gained ethical approval from The Hong Kong Polytechnic University and Vietnamese Ministry of Health. This study has followed the ethical principles for research that involves human subjects which are: autonomy, beneficence, non-maleficence, and confidentiality).
2.4. Data Analysis Data will be checked for normality, outliers, and missing data. Intention to treat principle is adapted for analyzing the result of the pilot study which use the "last value carried out forward" approach to replace missing data. Descriptive statistics will be used to analyze the sample characteristics, demographics, and data related to the intervention feasibility, acceptability and adverse event of acupressure. Baseline differences among the three groups will be compared by chi-square test and repeated measure ANOVA. In case the chi-square test is not appropriated because of low cell counts (≤ 5), it will be replaced by Fisher's exact test. The effect size will be calculated by Cohen d based on the mean difference between baseline and end of the treatment period for each symptom and the cluster of insomnia, depression, and anxiety in the true self-acupressure group and sham acupressure group. The significance level is set at 0.05. IBM SPSS 20.0 software will be used for data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- True self-acupressure group [Enhanced standard care + True self-acupressure]: Participants will practice the four-week acupressure protocol plus standard care. During the four weeks treatment, participants will receive a weekly phone call follow up from researchers. Sham self-acupressure group [Enhanced standard care + Sham self-acupressure]: Patients will practice the four weeks sham self-acupressure protocol plus standard care. During the four weeks treatment, participants will receive a weekly follow up phone call from researchers. Enhanced standard care group The enhanced standard care in this study refers to standard care provided by the hospital includes health assessment, nutrition advice during taking chemotherapy treatment, hypnotics (Prescribe only where necessary by a doctor), and the enhanced care provided by the main researcher includes patient leaflet of tips on managing insomnia, depression, and anxiety; weekly follow-up phone call in four weeks.
| Arm | Type | Receives |
|---|---|---|
| True self-acupressure group | Experimental | Other: Self-acupressureTrue self-acupressure group [Enhanced standard care + True self-acupressure intervention protocol]: Participants in this group will practice the four-week acupressure protocol plus standard care. When participants admit hospital to receive chemotherapy treatment, they will receive a self-acupressure training section. Participants will be requested to practice acupressure at home once a day at night time (before going to bed) for four weeks. During the four weeks treatment, participants will receive a weekly phone call follow up from researchers. |
| Sham self-acupressure group | Placebo comparator | Other: Sham Self-acupressurePatients in this group will practice the four weeks sham self-acupressure protocol plus standard care. When participants admit hospital to receive chemotherapy treatment, they will receive a self-acupressure training section. Participants will be requested to practice sham acupressure at home once a day at night time (before going to bed) for four weeks. During the four weeks treatment, participants will receive a weekly follow up phone call from researchers |
| Enhanced standard care group | No intervention | –The standard care for cancer patients undergoing chemotherapy includes health assessment, regular health advice regarding symptoms that patients report and nutrition advice during taking chemotherapy treatment. Apart from the standard care, we provide participants a leaflet with 10 recommendations which help participants manage insomnia, depression, and anxiety. By providing this leaflet, we slightly enhance the standard care but do not contaminate the effective of the intervention since these tips are basic and participants can easily read about them on the internet or newspaper. In addition, to minimize the bias caused by contacting between interventionist and participants, we also provide participants in the enhanced standard care group weekly follow up phone call in four weeks. |
Who may qualify
- Ages
- 20 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Undergoing chemotherapy currently.
- Able to read and write Vietnamese (to complete the questionnaires and provide informed consent).
- Have Karnofsky score ≥ 80 (to be able to practice self-acupressure).
- Have Insomnia Severity Index score ≥ 11
- Have Anxiety score measured by HADS ≥ 8 and Depression score measured by HADS ≥ 8
Key exclusion criteria (5 listed)
- Are unable to understand or cooperate with study procedures.
- Are receiving other cancer treatments (e.g., radiotherapy, hormonal therapy) at the same time as receiving chemotherapy and during the period of their involvement in the trial.
- Are participating in other research studies which may have interacted with the current trial or affect insomnia, depression, anxiety perception.
- Have difficulties or are unable to practice self-acupressure by themselves.
- Are receiving insomnia or depression/anxiety treatment currently.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-acupressureWe teach participants how to using self-acupressure to manage insomnia, depression, and anxiety. Six acupoints are included in our acupressure protocol which are Baihui, Yintang, Fengchi, Neiguan, Shenmen, and Taichong. Participants are requested to stimulate each acupoint in 3 minutes once a day (at night time before going to bed) in 28 days (4 weeks). During the four weeks treatment, participants will receive a weekly phone call follow up to remind them practice self-acupressure at home. Participant also receives a patient leaflet with 10 tips heil to manage insomnia, depression, and anxiety. These tips include some basic sleep hygiene rules and tips to manage anxiety and depression adapted from Anxiety and Depression Association of American. | Other | True self-acupressure group |
| Sham Self-acupressureWe using a sham acupressure protocol to teach participants in this group. Six sham acupoints are included in the protocol. The sham acupoints are located 2-5cm away from the true acupoints. Participants are requested to stimulate each sham acupoint in 3 minutes once a day (at night time before going to bed) in 28 days (4 weeks). During the four weeks treatment, participants will receive a weekly phone call follow up to remind them practice self-acupressure at home. Participant also receives a patient leaflet with 10 tips heil to manage insomnia, depression, and anxiety. These tips include some basic sleep hygiene rules and tips to manage anxiety and depression adapted from the Anxiety and Depression Association of American. | Other | Sham self-acupressure group |
Primary outcome
Number of eligible participants
Time frame: up to 15 weeks
The recruitment rate is calculated by dividing the number of the eligible participant by the total number of screened participants
Number of patients who refuse to participant in the study
Time frame: up to 15 weeks
The refusal rate is calculated by dividing the number of participants who do not participate in the study by the total number of eligible participants
Acceptability score of the intervention measured by participants
Time frame: One month after participants enroll the trial
The acceptability score of the intervention will be measured by The Intervention Rating Profile - 15 (Martens, Witt, Elliott, \& Darveaux, 1985). The Intervention Rating Profile - 15 (IRP-15) consists of 15 items; each item is rated on a six-point Likert scale ranging from one (Strongly disagree) to six (Strongly agree). The higher score indicated higher acceptability of the intervention. The scale had been validated, translated into Vietnamese with high reliability (Cronbach's α = 0.89) (Nguyen, Alexander, \& Yates, 2018)
Acceptability of study procedures measured by participants
Time frame: One month after participants enroll the trial
The attrition rate will be calculated by the number of participants who decide to discontinue the study and the number of participants who are lost to contact during the study period. Reason for dropping out and lost to contact will be recorded
Adverse events associated with self-acupressure reported by participants
Time frame: One month after participants enroll the trial
Participants will be requested to report potential adverse events related to acupressure in the "Self-Acupressure Record Form."
Change from baseline in insomnia score on Insomnia Severity Index at post intevention and after follow-up time
Time frame: Change from baseline insomnia severity at one month and two months
The Insomnia Severity Index (ISI) is used to measure insomnia severity among participants. The ISI is a self-reported questionnaire consisting of seven items to assess the nature, severity, and impact of insomnia. A score of 7 items indicates the insomnia severity, the min score is 0 and the maximum score is 28, the higher score indicates worse insomnia severity. The insomnia severity is interpreted as follows: moderate insomnia (ISI score of 15 to 21), severe insomnia (ISI score of 22 to 28). This instrument had been validated translated into Vietnamese previously (Long, Thanasilp, \& Thato, 2016) and was being used in our previous study with high reliability (Cronbach's α = 0.92).
Change of participants' sleep parameter in sleep diary from baseline at post intervention and after follow-up time
Time frame: Change from baseline at one month and two months
A sleep diary is used to measure sleep parameters. The participant will be requested to complete a one-week sleep diary before starting practice acupressure, after the treatment period ends, and after. The sleep diary is used to measure these sleep parameters: Total Sleep time (minute), total time in bed (minute), the number of night awaken after sleep onset and sleep efficiency.
Change from baseline in depression and anxiety scoreon Hospital Depression and Anxiety Scale at post intevention and after follow-up time
Time frame: Change from baseline depression and anxiety severity at one month and two months
The Hospital Anxiety and Depression Scale (HADS) was developed by Zigmond and Snaith (1983) to measure depression and anxiety among participants. This scale has 14 items, seven items measuring anxiety and seven items measuring depression over the past week. The total depression/anxiety score range from 0 to 28 with the higher total score indicates worse depression/anxiety. This instrument had been translated into Vietnamese previously (Long et al., 2016) and was used in our previous study with the Cronbach's alpha for the scale was 0.87, and for anxiety, subscale was 0.86, and for depression, subscale was 0.76.
Change from baseline in symptom cluster score on numerical analo scale from baseline at post intervetion and after follow-up time
Time frame: Change from baseline symptom cluster severity at one month and two months
Separate numerical analog scales (NAS) for each symptom will be used to measure the severity of the whole cluster in the previous month. The symptom severity score of each of symptom in the cluster will be measured by an 11-point scales with 0 means "not present" and 10 means "as bad as it could be." Symptom severity at the cluster level will be evaluated by the averaging symptom severity score of each symptom in the cluster.
Change in participants'quality of life on the Functional Assessment of Cancer Therapy-General scale from baseline at post intervention and after follow-up time
Time frame: Change from baseline quality of life at one month and two months
The Functional Assessment of Cancer Therapy-General (FACT-G) is used in this study to assess the quality of life in participants. The questionnaire consists of 27 items each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). This scale measures four sub-scales: Physical well-being (PWB, 7 items); Social/family well-being (SWB, 7 items); Emotional well-being (EWB, 6 items) and Functional well-being (FWB, 7 items). The total score range from 0 to 108, questions are phrased so that higher numbers indicate a better health state. Each subscale is scored, and a total score for the FACT-G is obtained by adding each of the subscale scores. This instrument has been translated into Vietnamese by the Functional Assessment of Chronic Illness Therapy system and had been used in the previous study with the Cronbach's alpha for the scale was 0.89, and for Emotional well-being, subscales were 0.78, FWB = 0.82, PWB = 0.81 and for SWB was 0.82.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Background: PubMed 26170519Abedian Z, Eskandari L, Abdi H, Ebrahimzadeh S. The Effect of Acupressure on Sleep Quality in Menopausal Women: A Randomized Control Trial. Iran J Med Sci. 2015 Jul;40(4):328-34.
- Background: PubMed 11304107Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T; CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001 Apr 17;134(8):663-94. doi: 10.7326/0003-4819-134-8-200104170-00012.
- Background: PubMed 12691682Anderson KO, Getto CJ, Mendoza TR, Palmer SN, Wang XS, Reyes-Gibby CC, Cleeland CS. Fatigue and sleep disturbance in patients with cancer, patients with clinical depression, and community-dwelling adults. J Pain Symptom Manage. 2003 Apr;25(4):307-18. doi: 10.1016/s0885-3924(02)00682-6.
- Background: PubMed 15367063Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.
- Background: PubMed 11832252Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
- Background: PubMed 22906948Bokmand S, Flyger H. Acupuncture relieves menopausal discomfort in breast cancer patients: a prospective, double blinded, randomized study. Breast. 2013 Jun;22(3):320-3. doi: 10.1016/j.breast.2012.07.015. Epub 2012 Aug 18.
- Background: PubMed 9703587Bonnet MH, Arand DL. Sleepiness as measured by modified multiple sleep latency testing varies as a function of preceding activity. Sleep. 1998 Aug 1;21(5):477-83.
- Background: PubMed 17040003Buysse DJ, Ancoli-Israel S, Edinger JD, Lichstein KL, Morin CM. Recommendations for a standard research assessment of insomnia. Sleep. 2006 Sep;29(9):1155-73. doi: 10.1093/sleep/29.9.1155.
- Background: PubMed 22294820Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.
- Background: PubMed 19034252Cerrone R, Giani L, Galbiati B, Messina G, Casiraghi M, Proserpio E, Meregalli M, Trabattoni P, Lissoni P, Gardani G. Efficacy of HT 7 point acupressure stimulation in the treatment of insomnia in cancer patients and in patients suffering from disorders other than cancer. Minerva Med. 2008 Dec;99(6):535-7.
- Background: PubMed 27531549Choi TY, Kim JI, Lim HJ, Lee MS. Acupuncture for Managing Cancer-Related Insomnia: A Systematic Review of Randomized Clinical Trials. Integr Cancer Ther. 2017 Jun;16(2):135-146. doi: 10.1177/1534735416664172. Epub 2016 Aug 16.
- Background: PubMed 26132682Chung KF, Yeung WF, Yu YM, Yung KP, Zhang SP, Zhang ZJ, Wong MT, Lee WK, Chan LW. Acupuncture for residual insomnia associated with major depressive disorder: a placebo- and sham-controlled, subject- and assessor-blind, randomized trial. J Clin Psychiatry. 2015 Jun;76(6):e752-60. doi: 10.4088/JCP.14m09124.
- Individual participant dataSharing planned: No. As required by ethical principals, we will not share IPD to other researchers in order to protect the participant's personal information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huong TX Hoang study director
The Hong Kong Polytechnic University
Alex Molassiotis principal investigator
The Hong Kong Polytechnic University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-acupressure in people with Insomnia and Anxiety, run by The Hong Kong Polytechnic University at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huong TX Hoang, PhDc (0988919709, xuan-huong.hoangthi@connect.poly.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of eligible participants (time frame: up to 15 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03823456, which also lists 64 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.