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临床试验/NCT02187640
NCT02187640已完成1 期

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

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
78
试验地点
1
主要终点
Constipation Assessment Scale

研究概览

简要总结

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.

详细描述

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 .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Constipation Assessment Scale

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

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.

次要结局

  • Patient Assessment Constipation Quality of Life Questionnaire(Seventh week (i.e., two weeks after completion of the 10-day intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chien Wai-Tong

Professor and Associate Head

The Hong Kong Polytechnic University

研究点 (1)

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