Clinical trial NCT02187640: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Constipation
Keywords: Acupressure
Self-administration
Psychiatric in-patients
Constipation
Self-administered acupressure program
Sham control group
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility 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.

Primary outcomes:
measure: Constipation Assessment Scale
timeFrame: Baseline (0 week; before start of intervention)
measure: Constipation Assessment Scale
timeFrame: Fifth weeks (i.e., immediately after completion of the 10-day intervention)
measure: Constipation Assessment Scale
timeFrame: Seventh week (i.e., two weeks after completion of the intervention)
Secondary outcomes:
measure: Patient Assessment Constipation Quality of Life Questionnaire
timeFrame: Baseline (0 week; before start of intervention)
measure: Patient Assessment Constipation Quality of Life Questionnaire
timeFrame: Fifth week (i.e., immediately after completion of the 10-day intervention)
measure: Patient Assessment Constipation Quality of Life Questionnaire
timeFrame: Seventh week (i.e., two weeks after completion of the 10-day intervention)
Other outcomes:
Locations:
city: Tuen Mun
country: Hong Kong
facility: One Regional Mental Hospital
state: New Territories
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Wai Kit Wong, MN, DHSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.