- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02187640
Effects of Self-administered Acupressure in Psychiatric Patients With Constipation
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:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
New Territories
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Tuen Mun, New Territories, Hong Kong
- One Regional Mental Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria of psychiatric in-patients are:
- 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.
Exclusion criteria of those in-patients are:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Self-administered acupressure
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.
|
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 .
Other Names:
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Sham Comparator: Sham control group
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.
|
Sham intervention: Patients received similar aupressure intervention on the non-acupoints.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline (0 week; before start of intervention)
|
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.
|
Fifth weeks (i.e., immediately after completion of the 10-day intervention)
|
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.
|
Seventh week (i.e., two weeks after completion of the intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Assessment Constipation Quality of Life Questionnaire
Time Frame: Baseline (0 week; before start of intervention)
|
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.
|
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)
|
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.
|
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)
|
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.
|
Seventh week (i.e., two weeks after completion of the 10-day intervention)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Wai Kit Wong, MN, DHSc, The Hong Kong Polytechnic University
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- hkpusn01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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