Effect of Self- Administered Acupressure on Diarrhea Predominant Irritable Bowel Syndrome Patients' Health Outcomes: a Double Blind- Sham Controlled Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change from the baseline irritable Bowel Syndrome Symptom Severity Score at 2 weeks
研究概览
简要总结
This study aims to assess the effect of active self- administered acupressure compared to sham self- administered acupressure on the health outcome for patient with diarrhea predominant Irritable Bowel Syndrome
详细描述
Research suggests promising benefits of acupuncture in terms of symptom control and quality of life improvements in patients with irritable bowel syndrome. but the cost of the needle and the invasive nature of the procedure decreases patient compliance with acupuncture. in this respect, acupressure can be taught to patients to allow them to perform it themselves, instead of being administered by practitioners. Self-administered acupressure is less time-intensive, low-cost, and flexible to perform. Nurses involved in irritable bowel syndrome patient care play an active role in the practitioner-patient relationship By assessing the specific symptoms that are present, determining the severity of symptoms and the impact on the irritable bowel syndrome patient's life, and being knowledgeable of available treatment options, the nurse involved in irritable bowel syndrome care becomes an essential conduit of information and a valuable facilitator of a positive practitioner-patient therapeutic relationship. In this way, nurses can help to limit the negative consequences of this common disorder and improve overall treatment outcomes in this population. . Thus this study will be conducted to assess the effectiveness of active self-administered acupressure on diarrhea-predominant irritable bowel syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
a randomization sequence will be generated by an independent statistician. The randomization list will be recorded and enclosed in sequentially numbered, opaque envelopes. after finishing baseline assessment, the training researcher will open the envelopes to avoid selection bias. only the training researcher will know the group allocation. Participants and other relevant researchers (the outcome evaluator, data managers, and statisticians) will be blinded to the group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with diarrhea irritable bowel syndrome symptoms following Rome IV diagnostic criteria
- •Agreed to be on a fixed dose of the pharmacological therapy throughout the study
排除标准
- •Patients with severe lesions in major organs such as the heart, liver, and kidney, hematopoietic diseases, or tumors
- •Eating disorders
- •History of major abdominal surgery
- •History of neurological and mental illness
- •Usage of other treatment rather than the medical treatment regularly 2 weeks before randomization and throughout the study
- •Previous history of drug or alcohol abuse 6 months before randomization
- •Pregnant and lactating women.
- •Patient reporting of adequate relief of their irritable bowel syndrome symptoms the week preceding the randomization
- •Patient has too mild symptoms ( obtaining less than 75 on Irritable bowel syndrome symptoms severity scale at the baseline assessment)
- •Currently participating in other clinical trials
结局指标
主要结局
Change from the baseline irritable Bowel Syndrome Symptom Severity Score at 2 weeks
时间窗: after 2 weeks from the baseline
t is five item questionnaire measuring frequency and intensity of abdominal pain, the severity of abdominal distension, dissatisfaction with bowel habits, and the interference of IBS with daily life. Subjects respond to each question on a 100-point visual analogue scale. The total score ranges from 0 to 500. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (\>300) disease
Change from the baseline irritable Bowel Syndrome Symptom Severity Score at 4 weeks
时间窗: after 4 weeks from the baseline
t is five item questionnaire measuring frequency and intensity of abdominal pain, the severity of abdominal distension, dissatisfaction with bowel habits, and the interference of IBS with daily life. Subjects respond to each question on a 100-point visual analogue scale. The total score ranges from 0 to 500. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (\>300) disease
Change in the frequency of stool consistency at 2 weeks from the baseline
时间窗: after 2 weeks from baseline
defined by the Bristol Stool Form Scale
Baseline mean of irritable Bowel Syndrome Symptom Severity Score
时间窗: Immediately before assigning the participants to the study groups
It is five item questionnaire measuring frequency and intensity of abdominal pain, the severity of abdominal distension, dissatisfaction with bowel habits, and the interference of IBS with daily life. Subjects respond to each question on a 100-point visual analogue scale. The total score ranges from 0 to 500. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (\>300) disease
Change in the frequency of stool consistency at 4 weeks from the baseline
时间窗: after 4 weeks
Defined by the Bristol Stool Form Scale, It is an ordinal scale of stool types ranging from the hardest (Type 1) to the softest (Type 7). Types 1 and2 are considered to be abnormally hard stools while Types 6 and 7 are considered abnormally loose/liquid stools. Type 3, 4 and 5 are considered to be the most normal stool type
Irritable Bowel Syndrome Adequate Relief question
时间窗: After 4 weeks from the baseline
It is a dichotomous single item that asks participants "Over the past week have you had adequate relief of your irritable Bowel Syndrome symptoms?" . A responder was defined as a patient who answered this question affirmatively.
Mean stool frequency after 2 weeks
时间窗: After 2 weeks from the patient endorsement
Defined by the bi-weekly change of frequency of defecation,patient will report the number of defecation per day to calculate it.
Mean change of stool frequency after 4 weeks
时间窗: After 4 weeks from the patient endorsement
Defined by the bi-weekly change of frequency of defecation,patient will report the number of defecation per day to calculate it.
Stool consistency
时间窗: at the baseline
Defined by the Bristol Stool Form Scale, It is an ordinal scale of stool types ranging from the hardest (Type 1) to the softest (Type 7). Types 1 and2 are considered to be abnormally hard stools while Types 6 and 7 are considered abnormally loose/liquid stools. Type 3, 4 and 5 are considered to be the most normal stool type
次要结局
- Demographic and clinical data(before assignment of the participants to the study groups)
- Baseline mean of the quality of Life(at the baseline)
- Change from the baseline mean of the quality of life at 4 weeks(Four weeks after the baseline assessment)
- Related adverse Events(from the patients endorsement till one week after study completion)
- use of rescue medicine(throughout study completion, an average of 4 months)
- the baseline mean of psychological distress measured by the Hospital Anxiety and Depression Scale(at the baseline)
- Change from the baseline mean of the psychological distress measured by the Hospital Anxiety and Depression Scale at 4 weeks(after 4 weeks from the baseline)
- Adherence to the to active and sham self-administered acupressure of the study.(throughout study completion, an average of 4 months)
研究者
Maha Gamal Ramadan Asal
Principle investgator
Alexandria University