Effects of Self-administered Acupressure in Psychiatric Patients With Constipation

NCT02187640 | Completed Phase 1 DMC

• 1 other identifier: hkpusn01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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. 1.What are the effects of the standardized self-administered acupressure program on reducing those adult psychiatric patients' symptoms of constipation?
2. 2.What are the psychiatric patients' (participants') perceived benefits and limitations of self-administered acupressure on management of their constipation?
3. 3.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
4. 4.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.

Conditions

Constipation

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Constipation Assessment Scale

  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.

  Baseline (0 week; before start of intervention)

• Constipation Assessment Scale

  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.

  Fifth weeks (i.e., immediately after completion of the 10-day intervention)

• Constipation Assessment Scale

  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.

  Seventh week (i.e., two weeks after completion of the intervention)

Secondary Outcomes (3)

• 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)

• Patient Assessment Constipation Quality of Life Questionnaire

  Seventh week (i.e., two weeks after completion of the 10-day intervention)

Study Arms (2)

Self-administered acupressure

EXPERIMENTAL

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.

Behavioral: Self-administered acupressure

Sham control group

SHAM COMPARATOR

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.

Behavioral: Sham control group

Interventions

Self-administered acupressure 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 .

Also known as: Self-help acupressure therapy

Self-administered acupressure

Sham control group BEHAVIORAL

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

Sham control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• pregnancy.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

One Regional Mental Hospital

Tuenmen, New Territories, Hong Kong

Location

Related Publications (2)

• 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.

  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.

  PMID: 26535053 DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wai Kit Wong, MN, DHSc

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Head

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 11, 2014
• Study Start: June 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

HK (1)