A Randomised Controlled Trial of Self-administered Acupressure in Adult Psychiatric Patients With Constipation
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:
- 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.
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
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Self-administered acupressure
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.
干预措施: Self-administered acupressure (Behavioral)
Sham control group
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.
干预措施: Sham control group (Behavioral)
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.
Constipation Assessment Scale
时间窗: Baseline (0 week; before start of 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.
Constipation Assessment Scale
时间窗: Fifth weeks (i.e., immediately after completion of the 10-day 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))
- 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))
研究者
Chien Wai-Tong
Professor and Associate Head
The Hong Kong Polytechnic University