search
Back to results

Effects of Self-administered Acupressure in Psychiatric Patients With Constipation

Primary Purpose

Constipation

Status
Completed
Phase
Phase 1
Locations
Hong Kong
Study Type
Interventional
Intervention
Self-administered acupressure
Sham control group
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Acupressure, Self-administration, Psychiatric in-patients, Constipation, Self-administered acupressure program, Sham control group

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • One Regional Mental Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Self-administered acupressure

Sham control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Patient Assessment Constipation Quality of Life Questionnaire
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.
Patient Assessment Constipation Quality of Life Questionnaire
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.
Patient Assessment Constipation Quality of Life Questionnaire
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.

Full Information

First Posted
July 7, 2014
Last Updated
August 17, 2015
Sponsor
The Hong Kong Polytechnic University
search

1. Study Identification

Unique Protocol Identification Number
NCT02187640
Brief Title
Effects of Self-administered Acupressure in Psychiatric Patients With Constipation
Official Title
A Randomised Controlled Trial of Self-administered Acupressure in Adult Psychiatric Patients With Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Acupressure, Self-administration, Psychiatric in-patients, Constipation, Self-administered acupressure program, Sham control group

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-administered acupressure
Arm Type
Experimental
Arm 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.
Arm Title
Sham control group
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Self-administered acupressure
Other Intervention Name(s)
Self-help acupressure therapy
Intervention Description
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
Intervention Name(s)
Sham control group
Intervention Description
Sham intervention: Patients received similar aupressure intervention on the non-acupoints.
Primary Outcome Measure Information:
Title
Constipation Assessment Scale
Description
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.
Time Frame
Baseline (0 week; before start of intervention)
Title
Constipation Assessment Scale
Description
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.
Time Frame
Fifth weeks (i.e., immediately after completion of the 10-day intervention)
Title
Constipation Assessment Scale
Description
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.
Time Frame
Seventh week (i.e., two weeks after completion of the intervention)
Secondary Outcome Measure Information:
Title
Patient Assessment Constipation Quality of Life Questionnaire
Description
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.
Time Frame
Baseline (0 week; before start of intervention)
Title
Patient Assessment Constipation Quality of Life Questionnaire
Description
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.
Time Frame
Fifth week (i.e., immediately after completion of the 10-day intervention)
Title
Patient Assessment Constipation Quality of Life Questionnaire
Description
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.
Time Frame
Seventh week (i.e., two weeks after completion of the 10-day intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria of psychiatric in-patients are: 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. Exclusion criteria of those in-patients are: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Kit Wong, MN, DHSc
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
One Regional Mental Hospital
City
Tuen Mun
State/Province
New Territories
Country
Hong Kong

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
PubMed Identifier
26535053
Citation
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.
Results Reference
derived

Learn more about this trial

Effects of Self-administered Acupressure in Psychiatric Patients With Constipation

We'll reach out to this number within 24 hrs