Effects of Self-administered Acupressure in Psychiatric Patients With Constipation

Phase 1

Completed

• Conditions: Constipation
• Interventions: Behavioral: Sham control group; Behavioral: Self-administered acupressure

• Registration Number: NCT02187640
• Lead Sponsor: The Hong Kong Polytechnic University

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 .

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-11
• Primary Completion: 2015-06
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham control group	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.
Self-administered acupressure	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.

Primary Outcome Measures

Name	Time	Method
Constipation Assessment Scale	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.

Secondary Outcome Measures

Name	Time	Method
Patient Assessment Constipation Quality of Life Questionnaire	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.

Trial Locations

Locations (1)

One Regional Mental Hospital; 🇭🇰 Tuen Mun, New Territories, Hong Kong