Parents of Children With CancerNCT05654155
The Effectiveness of Auricular Acupressure on Sleep Quality, Mood Status, and Quality of Life
A study testing auricular acupressure in people with Parents of Children With Cancer, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
Trial summary
This pilot study aimed to determine the feasibility and effectiveness of an auricular acupressure intervention on sleep, mood state, and QOL among parents of children with cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parents of Children With Cancer
- What is being tested?
- auricular acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Nov 2019to 30 Nov 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parent of a child (less than 18 years old) who was newly diagnosed with cancer (less than 3 months).
- parent of a child and who was receiving treatment with chemotherapy Must be able to swallow tablets
Who cannot join
- Parents were receiving any medication or treatment for insomnia.
- Parents had received any acupuncture or acupressure in the recent 3 months.
- Parents had ever been diagnosed with other chronic illnesses (such as cancer, heart disease, or asthma) at the time of data collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of the Feasibility and Effectiveness of Auricular Acupressure in Managing Sleep Quality, Mood Status, and Quality of Life in Parents of Children With Cancer
This pilot study aimed to determine the feasibility and effectiveness of an auricular acupressure intervention on sleep, mood state, and QOL among parents of children with cancer.
Read the detailed description
This was a feasibility pilot study conducted using a randomized controlled design in which participants were randomly assigned to either an active auricular acupressure group (AAG) or a sham auricular acupressure group (SAG). Data were collected at baseline (time 0), and 1-week (time 1), 2-weeks (time 2) and 3-weeks (time 3) after the end of the intervention, which was 3 weeks long.
Participants To be included in the study, participants needed to be a parent of a child (less than 18 years old) who was newly diagnosed with cancer (less than 3 months) and who was receiving treatment with chemotherapy. Parents were excluded if they were: (1) receiving any medication or treatment for insomnia; (2) had received any acupuncture or acupressure in the recent 3 months; or (3) had ever been diagnosed with other chronic illnesses (such as cancer, heart disease, or asthma) at the time of data collection. The reason for excluding parents with chronic illnesses was to increase the similarity of subjects in this study, because such chronic illnesses may have an impact on sleep and mood.
Intervention: auricular acupressure program The AAG participants received auricular acupressure three times a day for five days every week for three weeks. Using Dr. Huang's ear reflex theory, our AAG intervention included six acupoints (i.e., shenmen, subcortex, heart, kidney, anxious, and neurasthenia points) that have been demonstrated to be effective in improving sleep and emotional stability 17, 18. Participants in SAG received the same protocol of auricular acupressure as the AAG, but six acupoints were used near the treated acupoints (e.g., sacroiliac, neck, stomach, wrist, tonsil, and tongue), which would have had no effects on participants' sleep and mood status.
Both acupressure interventions were started by cleaning the earlobe using 75% alcohol. Then, a small piece of adhesive tape with 2 seeds, which provide pressure at specific points was taped onto each selected auricular acupoint on a participant's ear. Next, the auricular therapist demonstrated the acupoints press technique to participants. The participants were asked to press one acupoint slightly to more firmly for 1 minute by themselves until they felt discomfort or tingling, then move to the next acupoint until all 6 acupoints were completed. The ear seed tapes were kept in place for 5 days and removed by participants for 2 days. After the 2-day rest period, the participant returned to the researcher to have the ear tapes replaced. Unilateral auricular points were used for the intervention and the treatment ear was changed to the other ear every week until the 3-week intervention was completed. All the auricular acupressure interventions were conducted by the same researcher.
- Conditions
- Parents of Children With Cancer
- Being tested
- auricular acupressure
- Keywords
- sleep quality, quality of life, auricular acupressure
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular acupressureOther
Auricular acupressure therapy is a well-established treatment strategy whose foundations lie in Traditional Chinese Medicine and is a therapy that is increasingly used in Western medicine.
| Study group | Role | What they receive |
|---|---|---|
| Auricular acupressure group | Experimental | The AAG participants received auricular acupressure three times a day for five days every week for three weeks. Using Dr. Huang's ear reflex theory, our AAG intervention included six acupoints (i.e., shenmen, subcortex, heart, kidney, anxious, and neurasthenia points) that have been demonstrated to be effective in improving sleep and emotional stability. Receives: Other: auricular acupressure |
| sham auricular acupressure group | Sham comparator | Participants in SAG received the same protocol of auricular acupressure as the AAG, but six acupoints were used near the treated acupoints (e.g., sacroiliac, neck, stomach, wrist, tonsil, and tongue), which would have had no effects on participants' sleep and mood status. Receives: Other: auricular acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality at baseline
The Pittsburgh Sleep Quality Index (PSQI) is a validated multidimensional measure that assesses individuals' sleep quality.
Measured: Data were collected before auricular acupressure intervention
Sleep Quality at week 1
The Pittsburgh Sleep Quality Index (PSQI) is a validated multidimensional measure that assesses individuals' sleep quality.
Measured: Data were collected in the first week after completing 5 days of auricular acupressure.
Sleep Quality at week 2
The Pittsburgh Sleep Quality Index (PSQI) is a validated multidimensional measure that assesses individuals' sleep quality.
Measured: Data were collected in the second week after auricular acupressure interventtion.
Sleep Quality at week 3
The Pittsburgh Sleep Quality Index (PSQI) is a validated multidimensional measure that assesses individuals' sleep quality.
Measured: Data were collected in the 3rd week after auricular acupressure interventtion.
Secondary outcomes (8)
Mood State at baseline
The Profile of Mood State (POMS) was developed to investigate individuals' mood status.
Measured: Data were collected before auricular acupressure intervention
Mood State at week 1
The Profile of Mood State (POMS) was developed to investigate individuals' mood status.
Measured: Data were collected in the first week after completing 5 days of auricular acupressure.
Mood State at week 2
The Profile of Mood State (POMS) was developed to investigate individuals' mood status.
Measured: Data were collected in the second week after auricular acupressure interventtion.
Mood State at week 3
The Profile of Mood State (POMS) was developed to investigate individuals' mood status.
Measured: Data were collected in the 3rd week after auricular acupressure interventtion.
Quality of Life Short-Form at baseline
The Quality of Life Short-Form 36 (QOL-SF) was used to measure quality of life in parents of children with cancer for this study.
Measured: Data were collected before auricular acupressure intervention
Quality of Life Short-Form at week 1
The Quality of Life Short-Form 36 (QOL-SF) was used to measure quality of life in parents of children with cancer for this study.
Measured: Data were collected in the first week after completing 5 days of auricular acupressure.
Quality of Life Short-Form at week 2
The Quality of Life Short-Form 36 (QOL-SF) was used to measure quality of life in parents of children with cancer for this study.
Measured: Data were collected in the second week after auricular acupressure interventtion.
Quality of Life Short-Form at week 3
The Quality of Life Short-Form 36 (QOL-SF) was used to measure quality of life in parents of children with cancer for this study.
Measured: Data were collected in the 3rd week after auricular acupressure interventtion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start30 Nov 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parents of Children With CancerStudies of the same condition, open and under way.
- 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
- The auricular acupressure group (AAG) participants received auricular acupressure three times a day for five days every week for three weeks. Using Dr. Huang's ear reflex theory, our AAG intervention included six acupoints (i.e., shenmen, subcortex, heart, kidney, anxious, and neurasthenia points) that have been demonstrated to be effective in improving sleep and emotional stability. Participants in SAG (sham auricular acupressure group) received the same protocol of auricular acupressure as the AAG, but six acupoints were used near the treated acupoints (e.g., sacroiliac, neck, stomach, wrist, tonsil, and tongue), which would have had no effects on participants' sleep and mood status.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Principal investigator, Yi-Chien Chiang, Chang Gung University of Science and Technology
- Investigators
- Yi-Chien Chiang, PhD, Principal investigator, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654155
- Sponsor's protocol ID
- CMRPF1H0081
- Status last verified
- Dec 2022
- First submitted
- 10 Nov 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiang YC, Chen SH, Moser DK, Wen YC, Lin YT, Hsiao YC. Effectiveness of auricular acupressure in managing sleep quality, mood, and quality of life in parents of children with cancer: A pilot randomized controlled trial. Asia Pac J Oncol Nurs. 2024 Sep 25;11(11):100601. doi: 10.1016/j.apjon.2024.100601. eCollection 2024 Nov.
PubMed 39582551
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Feasibility and Effectiveness of Auricular Acupressure in Managing Sleep Quality, Mood Status, and Quality of Life in Parents of Children With Cancer
- ClinicalTrials.gov ID
- NCT05654155
- Acronym / sponsor ID
- CMRPF1H0081
- Conditions
- Parents of Children With Cancer
- Keywords
- sleep quality, quality of life, auricular acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 16 Dec 2022 (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.
This pilot study aimed to determine the feasibility and effectiveness of an auricular acupressure intervention on sleep, mood state, and QOL among parents of children with cancer.
Detailed description
This was a feasibility pilot study conducted using a randomized controlled design in which participants were randomly assigned to either an active auricular acupressure group (AAG) or a sham auricular acupressure group (SAG). Data were collected at baseline (time 0), and 1-week (time 1), 2-weeks (time 2) and 3-weeks (time 3) after the end of the intervention, which was 3 weeks long.
Participants To be included in the study, participants needed to be a parent of a child (less than 18 years old) who was newly diagnosed with cancer (less than 3 months) and who was receiving treatment with chemotherapy. Parents were excluded if they were: (1) receiving any medication or treatment for insomnia; (2) had received any acupuncture or acupressure in the recent 3 months; or (3) had ever been diagnosed with other chronic illnesses (such as cancer, heart disease, or asthma) at the time of data collection. The reason for excluding parents with chronic illnesses was to increase the similarity of subjects in this study, because such chronic illnesses may have an impact on sleep and mood.
Intervention: auricular acupressure program The AAG participants received auricular acupressure three times a day for five days every week for three weeks. Using Dr. Huang's ear reflex theory, our AAG intervention included six acupoints (i.e., shenmen, subcortex, heart, kidney, anxious, and neurasthenia points) that have been demonstrated to be effective in improving sleep and emotional stability 17, 18. Participants in SAG received the same protocol of auricular acupressure as the AAG, but six acupoints were used near the treated acupoints (e.g., sacroiliac, neck, stomach, wrist, tonsil, and tongue), which would have had no effects on participants' sleep and mood status.
Both acupressure interventions were started by cleaning the earlobe using 75% alcohol. Then, a small piece of adhesive tape with 2 seeds, which provide pressure at specific points was taped onto each selected auricular acupoint on a participant's ear. Next, the auricular therapist demonstrated the acupoints press technique to participants. The participants were asked to press one acupoint slightly to more firmly for 1 minute by themselves until they felt discomfort or tingling, then move to the next acupoint until all 6 acupoints were completed. The ear seed tapes were kept in place for 5 days and removed by participants for 2 days. After the 2-day rest period, the participant returned to the researcher to have the ear tapes replaced. Unilateral auricular points were used for the intervention and the treatment ear was changed to the other ear every week until the 3-week intervention was completed. All the auricular acupressure interventions were conducted by the same researcher.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The auricular acupressure group (AAG) participants received auricular acupressure three times a day for five days every week for three weeks. Using Dr. Huang's ear reflex theory, our AAG intervention included six acupoints (i.e., shenmen, subcortex, heart, kidney, anxious, and neurasthenia points) that have been demonstrated to be effective in improving sleep and emotional stability. Participants in SAG (sham auricular acupressure group) received the same protocol of auricular acupressure as the AAG, but six acupoints were used near the treated acupoints (e.g., sacroiliac, neck, stomach, wrist, tonsil, and tongue), which would have had no effects on participants' sleep and mood status.
| Arm | Type | Receives |
|---|---|---|
| Auricular acupressure group | Experimental | Other: auricular acupressureThe AAG participants received auricular acupressure three times a day for five days every week for three weeks. Using Dr. Huang's ear reflex theory, our AAG intervention included six acupoints (i.e., shenmen, subcortex, heart, kidney, anxious, and neurasthenia points) that have been demonstrated to be effective in improving sleep and emotional stability. |
| sham auricular acupressure group | Sham comparator | Other: auricular acupressureParticipants in SAG received the same protocol of auricular acupressure as the AAG, but six acupoints were used near the treated acupoints (e.g., sacroiliac, neck, stomach, wrist, tonsil, and tongue), which would have had no effects on participants' sleep and mood status. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parent of a child (less than 18 years old) who was newly diagnosed with cancer (less than 3 months).
- parent of a child and who was receiving treatment with chemotherapy Must be able to swallow tablets
Key exclusion criteria (3 listed)
- Parents were receiving any medication or treatment for insomnia.
- Parents had received any acupuncture or acupressure in the recent 3 months.
- Parents had ever been diagnosed with other chronic illnesses (such as cancer, heart disease, or asthma) at the time of data collection.
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 |
|---|---|---|
| auricular acupressureAuricular acupressure therapy is a well-established treatment strategy whose foundations lie in Traditional Chinese Medicine and is a therapy that is increasingly used in Western medicine. | Other | Auricular acupressure group, sham auricular acupressure group |
Primary outcome
Sleep Quality at baseline
Time frame: Data were collected before auricular acupressure intervention
The Pittsburgh Sleep Quality Index (PSQI) is a validated multidimensional measure that assesses individuals' sleep quality.
Sleep Quality at week 1
Time frame: Data were collected in the first week after completing 5 days of auricular acupressure.
The Pittsburgh Sleep Quality Index (PSQI) is a validated multidimensional measure that assesses individuals' sleep quality.
Sleep Quality at week 2
Time frame: Data were collected in the second week after auricular acupressure interventtion.
The Pittsburgh Sleep Quality Index (PSQI) is a validated multidimensional measure that assesses individuals' sleep quality.
Sleep Quality at week 3
Time frame: Data were collected in the 3rd week after auricular acupressure interventtion.
The Pittsburgh Sleep Quality Index (PSQI) is a validated multidimensional measure that assesses individuals' sleep quality.
8 secondary outcomes
Mood State at baseline
Time frame: Data were collected before auricular acupressure intervention
Mood State at week 1
Time frame: Data were collected in the first week after completing 5 days of auricular acupressure.
Mood State at week 2
Time frame: Data were collected in the second week after auricular acupressure interventtion.
Mood State at week 3
Time frame: Data were collected in the 3rd week after auricular acupressure interventtion.
Quality of Life Short-Form at baseline
Time frame: Data were collected before auricular acupressure intervention
Quality of Life Short-Form at week 1
Time frame: Data were collected in the first week after completing 5 days of auricular acupressure.
Quality of Life Short-Form at week 2
Time frame: Data were collected in the second week after auricular acupressure interventtion.
Quality of Life Short-Form at week 3
Time frame: Data were collected in the 3rd week after auricular acupressure interventtion.
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 16 Dec 2022.
- Derived from this study: PubMed 39582551Chiang YC, Chen SH, Moser DK, Wen YC, Lin YT, Hsiao YC. Effectiveness of auricular acupressure in managing sleep quality, mood, and quality of life in parents of children with cancer: A pilot randomized controlled trial. Asia Pac J Oncol Nurs. 2024 Sep 25;11(11):100601. doi: 10.1016/j.apjon.2024.100601. eCollection 2024 Nov.
- Individual participant dataSharing planned: No
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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.
Yi-Chien Chiang, PhD principal investigator
Chang Gung University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auricular acupressure in people with Parents of Children With Cancer, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
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 2 inclusion and 3 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 16 Dec 2022. 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 Taiwan. 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?
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?
Sleep Quality at baseline (time frame: Data were collected before auricular acupressure intervention). The study lists 4 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 NCT05654155, which also lists 1 linked publication.
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 16 Dec 2022.