A Randomised Controlled Trial of Self-administered Acupressure in Adult Psychiatric Patients With Constipation
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Constipation Assessment Scale
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Self-administered acupressure (Behavioral)
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.
Intervention: Sham control group (Behavioral)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Patient Assessment Constipation Quality of Life Questionnaire(Seventh week (i.e., two weeks after completion of the 10-day intervention))
- Patient Assessment Constipation Quality of Life Questionnaire(Baseline (0 week; before start of intervention))
- Patient Assessment Constipation Quality of Life Questionnaire(Fifth week (i.e., immediately after completion of the 10-day intervention))
Investigators
Chien Wai-Tong
Professor and Associate Head
The Hong Kong Polytechnic University