Effects of Self-administered Acupressure in Psychiatric Patients With Constipation

The Hong Kong Polytechnic University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Constipation

Treatments: Behavioral: Self-administered acupressure; Behavioral: Sham control group

Study type: Interventional

Funder types: Other

Identifiers

NCT02187640

hkpusn01

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 78 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups

Self-administered acupressure

Experimental group

Description:

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.

Treatment:

Behavioral: Self-administered acupressure

Sham control group

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Sham control group