Effects of Self-administered Acupressure in Psychiatric Patients With Constipation

NCT ID: NCT02187640

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-07-31

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 .

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Self-administered acupressure

Intervention Type: BEHAVIORAL

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 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.

Group Type: SHAM_COMPARATOR

Sham control group

Intervention Type: BEHAVIORAL

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

Interventions

Self-administered acupressure

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 .

Intervention Type: BEHAVIORAL

Sham control group

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Self-help acupressure therapy

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Chien Wai-Tong

Professor and Associate Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wai Kit Wong, MN, DHSc

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

One Regional Mental Hospital

Tuenmen, New Territories, Hong Kong

Countries

Hong Kong

References

1. Wong, W.K., & Chien, W.T. (2014). Evaluation the effect of Acupressure protocol on Adult psychiatric in-patients with constipation (Program book p. 55). The 35th International Association for Human Caring Conference - 'The Universality of Caring' (24 - 28 May 2014). Kyoto International Conference Center, Kyoto. Division of Family Health Care Nursing, Kobe University Graduate School of Health Sciences, Japan.

Reference Type: RESULT

Wong WK, Chien WT, Lee WM. Self-administered acupressure for treating adult psychiatric patients with constipation: a randomized controlled trial. Chin Med. 2015 Nov 3;10:32. doi: 10.1186/s13020-015-0064-7. eCollection 2015.

Reference Type: DERIVED

PMID: 26535053 (View on PubMed)

Other Identifiers

hkpusn01

Identifier Type: -

Identifier Source: org_study_id