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Effects of Self-administered Acupressure in Psychiatric Patients With Constipation

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02187640
Enrollment
78
Registered
2014-07-11
Start date
2013-06-30
Completion date
2015-07-31
Last updated
2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

Acupressure, Self-administration, Psychiatric in-patients, Constipation, Self-administered acupressure program, Sham control group

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: 1. What are the effects of the standardized self-administered acupressure program on reducing those adult psychiatric patients' symptoms of constipation? 2. 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: 1. 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 2. 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 .

Interventions

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 intervention: Patients received similar aupressure intervention on the non-acupoints.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

of psychiatric in-patients are: 1. Hong Kong Chinese residents, aged 18 to 64 years; 2. satisfied with Rome III diagnostic criteria for constipation; and 3. mentally stable and competent for self-care and learning acupressure, as recommended by their attending psychiatrists.

Exclusion criteria

of those in-patients are: 1. anatomical and physiological disorders of gastrointestinal tract such as malrotation, fistula and colonic neuropathies; 2. metabolic and endocrine diseases; 3. lead poisoning and vitamin D intoxication; 4. previous training in acupressure; 5. physical disability involved the upper limbs; 6. planned surgery undergoing during study period; and 7. pregnancy.

Design outcomes

Primary

MeasureTime frameDescription
Constipation Assessment ScaleBaseline (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.

Secondary

MeasureTime frameDescription
Patient Assessment Constipation Quality of Life QuestionnaireBaseline (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.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026