Effects of Self-administered Acupressure in Psychiatric Patients With Constipation

Study Overview
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Brief Summary
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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
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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 .

Official Title
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A Randomised Controlled Trial of Self-administered Acupressure in Adult Psychiatric Patients With Constipation

Conditions
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Constipation

Intervention / Treatment
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* Behavioral: Self-administered acupressure
* Behavioral: Sham control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-administered acupressure<br>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. | Behavioral: Self-administered acupressure<br>* 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 .<br>* Other names: Self-help acupressure therapy;|
| Sham Comparator: Sham control group<br>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. | Behavioral: Sham control group<br>* Sham intervention: Patients received similar aupressure intervention on the non-acupoints.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupressure, Self-administration, Psychiatric in-patients, Constipation, Self-administered acupressure program, Sham control group