Effects of Self-administered Acupressure in Psychiatric Patients With Constipation

Constipation Clinical Trial

Official title:

A Randomised Controlled Trial of Self-administered Acupressure in Adult Psychiatric Patients With Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02187640
• Other study ID #: hkpusn01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 7, 2014
• Last updated: August 17, 2015
• Start date: June 2013
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: School Research Committee, The Hong Kong Polytechnic University
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Behavioral:
• 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 .
• Sham control group
Sham intervention: Patients received similar aupressure intervention on the non-acupoints.

Locations

Country	Name	City	State
Hong Kong	One Regional Mental Hospital	Tuen Mun	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

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 -

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	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.	Baseline (0 week; before start of intervention)	No
Secondary	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.	Fifth week (i.e., immediately after completion of the 10-day intervention)	No
Secondary	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.	Seventh week (i.e., two weeks after completion of the 10-day intervention)	No