The Effects of Imagery Treatments vs Progressive Muscle Relaxation Therapy in Terms of Clinical, Psychological and Physiological Aspects Among Patients With Functional Abdominal Bloating
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Symptoms severity
研究概览
简要总结
65% of the general population reported experiencing moderate to severe bloating symptoms. Bloating could be disturbing to patients and frustrating to the physicians as an effective treatment is still lacking. Guided Imagery (GI) involves the structured visualisation of mental images with somatic sensory; whereas Progressive Muscle Relaxation (PMR) focuses on tightening and relaxing the body's specific muscle groups. The development and validation of GI or PMR interventions to treat patients with functional abdominal bloating are relatively novel.
详细描述
The baseline variables of the patient would be obtained at the outpatient Gastrointestinal Medical clinic. A thorough general clinical interview that encompasses medical and psychological history, discussion of the nature and severity of the current symptoms, and review of past treatments and conclusions of any medical evaluation and tests. This is to make sure that the patients have been comprehensively evaluated medically and to rule out other causes of abdominal bloating before reaching a firm diagnosis of functional abdominal bloating as suggested in ROME IV Criteria. Questionnaires will be given out and patients were asked to fill it up on the spot. Electrical activity and abdominal circumference would be measured at an enclosed space with appropriate privacy and accompanied by a chaperone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with abdominal bloating as determined using the Malay version Rome III criteria which was validated and translated by past researchers (Lee et al, 2012) and/or patients who were suggested by clinicians.
- •Participants must be 18 years and above, and of either gender.
- •Participants are able to read, write, or understand the Malay language.
排除标准
- •Patients with abdominal bloating due to organic disorder
- •Patients with recent abdominal surgeries (within 3 months) or previous major abdominal surgeries
- •Patients with major neurological and psychological disorders including stroke, schizophrenia, major depression.
- •Patients with medical history which may be the red flag for other FGIDs and organic disorders .
- •Patients who are on psychotropic medications or psychotherapy which may confound outcome of imagery of sham intervention.
结局指标
主要结局
Symptoms severity
时间窗: 1 month
Measured using the Malay version of Bloating Severity Questionnaire (BSQ-M). It consists of two components: five-item Sev24 and seven-item SevGen. The responses were in a multiple-choice answer format on different degrees of effect towards individuals on the basis of intensity, frequency and severity (less severe to more severe; range 1 to 4,5,6,7 or 8 varied by items). Higher scores in BSQ indicate worse severity.
次要结局
- Abdominal circumference(1 month)
- Quality of life for patients with abdominal bloating(1 month)
- Health seeking Intention(1 month)
- Health belief(1 month)
- Health promoting behavior(1 month)
- Anxiety(1 month)
- Depression(1 month)
- Electrical activity(1 month)
研究者
Vincent Tee Wei Shen
Principle Investigator
Universiti Sains Malaysia