ConstipationPhase 1/2NCT02187640
Effects of Self-administered Acupressure in Psychiatric Patients With Constipation
A Phase 1/2 study testing Self-administered acupressure in people with Constipation, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study is to evaluate the effects of self-administered acupressure therapy for psychiatric in-patients with constipation Two main research questions include: 1. What are the effects of the standardized self-administered acupressure program on reducing those adult psychiatric patients' symptoms of constipation? 2. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Constipation
- What is being tested?
- Self-administered acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2013to Jul 2015
- Phase
- Phase 1/2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hong Kong Chinese residents, aged 18 to 64 years;
- satisfied with Rome III diagnostic criteria for constipation; and
- mentally stable and competent for self-care and learning acupressure, as recommended by their attending psychiatrists.
Who cannot join
- anatomical and physiological disorders of gastrointestinal tract such as malrotation, fistula and colonic neuropathies;
- metabolic and endocrine diseases;
- lead poisoning and vitamin D intoxication;
- previous training in acupressure;
- physical disability involved the upper limbs;
- planned surgery undergoing during study period; and
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of Self-administered Acupressure in Adult Psychiatric Patients With Constipation
This study is to evaluate the effects of self-administered acupressure therapy for psychiatric in-patients with constipation
Two main research questions include:
Read more
- What are the effects of the standardized self-administered acupressure program on reducing those adult psychiatric patients' symptoms of constipation?
- What are the psychiatric patients' (participants') perceived benefits and limitations of self-administered acupressure on management of their constipation?
In this study, the participants who met the study criteria and completed the baseline measurement would be randomly assigned into either the self-administered acupressure program, or a sham control group who receive a placebo, non-acupoint pressure. The null hypotheses of this study are:
- There is no significant difference between the acupressure and sham group immediately and/or two weeks after the completion of intervention on patients' symptom severity of constipation; and
- There is no significant difference between the acupressure and sham group on patients' perceived quality of life at immediately and two weeks after treatment completion.
Read the detailed description
Main outcomes of this study include the Constipation Assessment Scale (CAS), Patient Assessment Constipation Quality of Life Questionnaire (PAC-QoL), and the socio-demographic and clinical data collected by a trained assessor who was blind to the intervention assignment of the participants. These data would be measured at recruitment (baseline) and immediately (Post-test 1) and two weeks (Post-test 2) after completion of the 10-day intervention. Qualitative focus group interview data would be collected after Post-test 2 .
- Conditions
- Constipation
- Being tested
- Self-administered acupressure, Sham control group
- Keywords
- Acupressure, Self-administration, Psychiatric in-patients, Constipation, Self-administered acupressure program, Sham control group
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered acupressureBehavioural
Also called Self-help acupressure therapy
Self-administered acupressure: In order to ensure the compliance of treatment, they would apply this intervention according to the acupressure group protocol once per day in groups with one trained research nurse's instructions and supervision .
Sham control groupBehavioural
Sham intervention: Patients received similar aupressure intervention on the non-acupoints.
| Study group | Role | What they receive |
|---|---|---|
| Self-administered acupressure | Experimental | A 10-day self-administered acupressure program was implemented by the participants who were adult psychiatric in-patients and randomly assigned into this treatment group. The patients would receive a 3-session training of this therapy conducted by a qualified acupressure therapist and each session lasted about an hour. They would be assessed by the trainer to ensure that they are able to identify the five acupoints and applied a constant and an appropriate pressure on each acupoint before actual implementation. Receives: Behavioral: Self-administered acupressure |
| Sham control group | Sham comparator | Sham control group: Patients would receive 3-session training and be assessed by the trainer. However, they would be trained to locate five non-acupoints adjacent to the actual acupoints and with minimal pressure applied. Receives: Behavioral: Sham control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation Assessment Scale
The 8-item Constipation Assessment Scale is an universal measurement tool for symptom severity of constipation in a wide variety of acute and chronic diseases and rated on a 3-point likert scale, ranging from '0= no problem', 1= some problem', and '2= severe problem'. A higher total score will indicate the more severe condition of one's constipation.
Measured: Baseline (0 week; before start of intervention)
Constipation Assessment Scale
The 8-item Constipation Assessment Scale is an universal measurement tool for symptom severity of constipation in a wide variety of acute and chronic diseases and rated on a 3-point likert scale, ranging from '0= no problem', 1= some problem', and '2= severe problem'. A higher total score will indicate the more severe condition of one's constipation.
Measured: Fifth weeks (i.e., immediately after completion of the 10-day intervention)
Constipation Assessment Scale
The 8-item Constipation Assessment Scale is an universal measurement tool for symptom severity of constipation in a wide variety of acute and chronic diseases and rated on a 3-point likert scale, ranging from '0= no problem', 1= some problem', and '2= severe problem'. A higher total score will indicate the more severe condition of one's constipation.
Measured: Seventh week (i.e., two weeks after completion of the intervention)
Secondary outcomes (3)
Patient Assessment Constipation Quality of Life Questionnaire
The Patient Assessment Constipation Quality of Life Questionnaire is a self-administered questionnaire for assessment of the magnitude and degree of interference associated with constipation symptomatology. The scale is composed of 28 items categorized into four subscales, including dissatisfaction (5 items), physical discomfort (4 items), psychosocial discomfort (8 items), and worries and concerns (11 items). Subjects rate each item on a 5-pont likert scale, ranging from '0 = none of the time or not at all to 4 = all of the time or extremely'. The overall and subscale scores can range from 0 to 4, with a lower total score indicating a better health-related quality of life.
Measured: Baseline (0 week; before start of intervention)
Patient Assessment Constipation Quality of Life Questionnaire
The Patient Assessment Constipation Quality of Life Questionnaire is a self-administered questionnaire for assessment of the magnitude and degree of interference associated with constipation symptomatology. The scale is composed of 28 items categorized into four subscales, including dissatisfaction (5 items), physical discomfort (4 items), psychosocial discomfort (8 items), and worries and concerns (11 items). Subjects rate each item on a 5-pont likert scale, ranging from '0 = none of the time or not at all to 4 = all of the time or extremely'. The overall and subscale scores can range from 0 to 4, with a lower total score indicating a better health-related quality of life.
Measured: Fifth week (i.e., immediately after completion of the 10-day intervention)
Patient Assessment Constipation Quality of Life Questionnaire
The Patient Assessment Constipation Quality of Life Questionnaire is a self-administered questionnaire for assessment of the magnitude and degree of interference associated with constipation symptomatology. The scale is composed of 28 items categorized into four subscales, including dissatisfaction (5 items), physical discomfort (4 items), psychosocial discomfort (8 items), and worries and concerns (11 items). Subjects rate each item on a 5-pont likert scale, ranging from '0 = none of the time or not at all to 4 = all of the time or extremely'. The overall and subscale scores can range from 0 to 4, with a lower total score indicating a better health-related quality of life.
Measured: Seventh week (i.e., two weeks after completion of the 10-day intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJun 2013
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien Wai-Tong, The Hong Kong Polytechnic University
- Investigators
- Wai Kit Wong, MN, DHSc, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187640
- Sponsor's protocol ID
- hkpusn01
- Status last verified
- Aug 2015
- First submitted
- 7 Jul 2014
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1. Wong, W.K., & Chien, W.T. (2014). Evaluation the effect of Acupressure protocol on Adult psychiatric in-patients with constipation (Program book p. 55). The 35th International Association for Human Caring Conference - 'The Universality of Caring' (24 - 28 May 2014). Kyoto International Conference Center, Kyoto. Division of Family Health Care Nursing, Kobe University Graduate School of Health Sciences, Japan.
Wong WK, Chien WT, Lee WM. Self-administered acupressure for treating adult psychiatric patients with constipation: a randomized controlled trial. Chin Med. 2015 Nov 3;10:32. doi: 10.1186/s13020-015-0064-7. eCollection 2015.
PubMed 26535053
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Self-administered Acupressure in Adult Psychiatric Patients With Constipation
- ClinicalTrials.gov ID
- NCT02187640
- Acronym / sponsor ID
- hkpusn01
- Conditions
- Constipation
- Keywords
- Acupressure, Self-administration, Psychiatric in-patients, Constipation, Self-administered acupressure program, Sham control group
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Jul 2014 (estimated)
- 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.
This study is to evaluate the effects of self-administered acupressure therapy for psychiatric in-patients with constipation
Two main research questions include:
- What are the effects of the standardized self-administered acupressure program on reducing those adult psychiatric patients' symptoms of constipation?
- What are the psychiatric patients' (participants') perceived benefits and limitations of self-administered acupressure on management of their constipation?
In this study, the participants who met the study criteria and completed the baseline measurement would be randomly assigned into either the self-administered acupressure program, or a sham control group who receive a placebo, non-acupoint pressure. The null hypotheses of this study are:
- There is no significant difference between the acupressure and sham group immediately and/or two weeks after the completion of intervention on patients' symptom severity of constipation; and
- There is no significant difference between the acupressure and sham group on patients' perceived quality of life at immediately and two weeks after treatment completion.
Detailed description
Main outcomes of this study include the Constipation Assessment Scale (CAS), Patient Assessment Constipation Quality of Life Questionnaire (PAC-QoL), and the socio-demographic and clinical data collected by a trained assessor who was blind to the intervention assignment of the participants. These data would be measured at recruitment (baseline) and immediately (Post-test 1) and two weeks (Post-test 2) after completion of the 10-day intervention. Qualitative focus group interview data would be collected after Post-test 2 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-administered acupressure | Experimental | Behavioral: Self-administered acupressureA 10-day self-administered acupressure program was implemented by the participants who were adult psychiatric in-patients and randomly assigned into this treatment group. The patients would receive a 3-session training of this therapy conducted by a qualified acupressure therapist and each session lasted about an hour. They would be assessed by the trainer to ensure that they are able to identify the five acupoints and applied a constant and an appropriate pressure on each acupoint before actual implementation. |
| Sham control group | Sham comparator | Behavioral: Sham control groupSham control group: Patients would receive 3-session training and be assessed by the trainer. However, they would be trained to locate five non-acupoints adjacent to the actual acupoints and with minimal pressure applied. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Hong Kong Chinese residents, aged 18 to 64 years;
- satisfied with Rome III diagnostic criteria for constipation; and
- mentally stable and competent for self-care and learning acupressure, as recommended by their attending psychiatrists.
Key exclusion criteria (7 listed)
- anatomical and physiological disorders of gastrointestinal tract such as malrotation, fistula and colonic neuropathies;
- metabolic and endocrine diseases;
- lead poisoning and vitamin D intoxication;
- previous training in acupressure;
- physical disability involved the upper limbs;
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-administered acupressureAlso: Self-help acupressure therapySelf-administered acupressure: In order to ensure the compliance of treatment, they would apply this intervention according to the acupressure group protocol once per day in groups with one trained research nurse's instructions and supervision . | Behavioural | Self-administered acupressure |
| Sham control groupSham intervention: Patients received similar aupressure intervention on the non-acupoints. | Behavioural | Sham control group |
Primary outcome
Constipation Assessment Scale
Time frame: Baseline (0 week; before start of intervention)
The 8-item Constipation Assessment Scale is an universal measurement tool for symptom severity of constipation in a wide variety of acute and chronic diseases and rated on a 3-point likert scale, ranging from '0= no problem', 1= some problem', and '2= severe problem'. A higher total score will indicate the more severe condition of one's constipation.
Constipation Assessment Scale
Time frame: Fifth weeks (i.e., immediately after completion of the 10-day intervention)
The 8-item Constipation Assessment Scale is an universal measurement tool for symptom severity of constipation in a wide variety of acute and chronic diseases and rated on a 3-point likert scale, ranging from '0= no problem', 1= some problem', and '2= severe problem'. A higher total score will indicate the more severe condition of one's constipation.
Constipation Assessment Scale
Time frame: Seventh week (i.e., two weeks after completion of the intervention)
The 8-item Constipation Assessment Scale is an universal measurement tool for symptom severity of constipation in a wide variety of acute and chronic diseases and rated on a 3-point likert scale, ranging from '0= no problem', 1= some problem', and '2= severe problem'. A higher total score will indicate the more severe condition of one's constipation.
3 secondary outcomes
Patient Assessment Constipation Quality of Life Questionnaire
Time frame: Baseline (0 week; before start of intervention)
Patient Assessment Constipation Quality of Life Questionnaire
Time frame: Fifth week (i.e., immediately after completion of the 10-day intervention)
Patient Assessment Constipation Quality of Life Questionnaire
Time frame: Seventh week (i.e., two weeks after completion of the 10-day intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- Results publication1. Wong, W.K., & Chien, W.T. (2014). Evaluation the effect of Acupressure protocol on Adult psychiatric in-patients with constipation (Program book p. 55). The 35th International Association for Human Caring Conference - 'The Universality of Caring' (24 - 28 May 2014). Kyoto International Conference Center, Kyoto. Division of Family Health Care Nursing, Kobe University Graduate School of Health Sciences, Japan.
- Derived from this study: PubMed 26535053Wong WK, Chien WT, Lee WM. Self-administered acupressure for treating adult psychiatric patients with constipation: a randomized controlled trial. Chin Med. 2015 Nov 3;10:32. doi: 10.1186/s13020-015-0064-7. eCollection 2015.
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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.
Wai Kit Wong, MN, DHSc principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Self-administered acupressure in people with Constipation, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation Assessment Scale (time frame: Baseline (0 week; before start of intervention)). The study lists 3 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 NCT02187640, which also lists 2 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 19 Aug 2015.