Self- Administered Acupressure for Diarrhea Predominant Irritable Bowel Syndrome

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Effect of Self- Administered Acupressure on Diarrhea Predominant Irritable Bowel Syndrome Patients' Health Outcomes: a Double Blind- Sham Controlled Randomized Clinical Trial

Conditions
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Irritable Bowel Syndrome With Diarrhea

Intervention / Treatment
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* Other: Active acupressure
* Other: Sham acuptressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with diarrhea irritable bowel syndrome symptoms in accordance with Rome IV diagnostic criteria Agreed to be on a fixed dose of the pharmacological therapy throughout the study Exclusion Criteria: Patients with severe lesions in major organs such as 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 on a regular basis 2 weeks prior to randomization and throughout the study Previous history of drug or alcohol abuse 6 months prior to 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, i.e. not visual analogue scale >40 on any of the five GI questions of irritable bowel syndrome symptoms severity index Currently participating in other clinical trials

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active acupoints group<br>All participants in the active group will be treated with basic acupoints Zhongwan (CV 12), Tianshu (ST25) in alternation with Sanyinjiao (SP 6), Zusanli (ST 36). Moreover according to traditional Chinese medicine diagnosis, additional acupoints will be added. The frequency of acupressure treatment will be twice a day for 4 weeks, in total 56 sets. | Other: Active acupressure<br>* Participants will receive training (2 sessions, 2 days a part) by a training researcher. Patients will be taught on the acupoints location and the acupressure technique. Participants will be verified for the correct location of the acupoints, acupressure technique and strength. Participants will be instructed to use thumb or middle finger to self- press each acupoint using circular movements. The force of pressing must be sufficiently strong but still within a comfortable range. A lubricant will be uses to decrease friction between the acupoints and the finger. Follow up evaluation will be at the end of the week 2 and week 4 .The training researcher will make weekly calls to remind participants to perform acupressure and to answer questions<br>|
| Sham Comparator: Sham acupoints group<br>All participants on the sham acupoints group will recieive sham Zhongwan (CV 12), sham Tianshu (ST25), sham Sanyinjiao (SP 6), and sham Zusanli (ST 36) acupressure. All the sham points are 2 cm outside and parallel to the actual points which do not match any recognized acupuncture points and are thought to have no therapeutic effect. The frequency of acupressure treatment will be twice a day for 4 weeks, in total 56 sets. | Other: Sham acuptressure<br>* The same protocol as the active acupressure group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline mean of irritable Bowel Syndrome Symptom Severity Score | 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 | Immediately before assigning the participants to the study groups | 
| Change from the baseline irritable Bowel Syndrome Symptom Severity Score at 2 weeks | 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 | after 2 weeks from the baseline | 
| Change from the baseline irritable Bowel Syndrome Symptom Severity Score at 4 weeks | 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 | after 4 weeks from the baseline | 
| Irritable Bowel Syndrome Adequate Relief question | 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. | At the baseline | 
| Irritable Bowel Syndrome Adequate Relief question | 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. | After 2 weeks from the baseline | 
| Irritable Bowel Syndrome Adequate Relief question | 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. | After 4 weeks from the baseline | 
| Mean stool frequency after 2 weeks | Defined by the bi-weekly change of frequency of defecation,patient will report the number of defecation per day to calculate it. | After 2 weeks from the patient endorsement | 
| Mean change of stool frequency after 4 weeks | Defined by the bi-weekly change of frequency of defecation,patient will report the number of defecation per day to calculate it. | After 4 weeks from the patient endorsement | 
| Stool consistency | 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 | at the baseline | 
| Change in the frequency of stool consistency at 2 weeks from the baseline | defined by the Bristol Stool Form Scale | after 2 weeks from baseline | 
| Change in the frequency of stool consistency at 4 weeks from 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 | after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic and clinical data | A questionnaire will be developed to collect data about participants' age, gender, body mass index, physical activity status, diet, smoking status, medication used. | before assignment of the participants to the study groups | 
| the baseline mean of psychological distress measured by the Hospital Anxiety and Depression Scale | the scale contains 14 items, seven statements on each sub-scale which assess symptoms experienced during the past week on four-point rating scale (0 to 3); a higher score depicts a worse condition. For each sub-scale the maximum score is 21. A score of ≥11 is considered a clinically significant disorder, whereas a score between 8 and 10 suggests a mild disorder | at the baseline | 
| Change from the baseline mean of the psychological distress measured by the Hospital Anxiety and Depression Scale at 4 weeks | the scale contains 14 items, seven statements on each sub-scale which assess symptoms experienced during the past week on four-point rating scale (0 to 3); a higher score depicts a worse condition. For each sub-scale the maximum score is 21. A score of ≥11 is considered a clinically significant disorder, whereas a score between 8 and 10 suggests a mild disorder | after 4 weeks from the baseline | 
| Baseline mean of the quality of Life | it will be measured by the irritable bowel syndrome quality of Life questionnaire. It consists of 34 items that assess the degree to which irritable bowel syndrome disturbed quality of life for a subject over the past 30 days through eight sub-scales. Each item is rated on a 5-point scale ranging from 1 to 5 with higher values indicating a lower quality of life. | at the baseline | 
| Change from the baseline mean of the quality of life at 4 weeks | it will be measured by the irritable bowel syndrome quality of Life questionnaire. It consists of 34 items that assess the degree to which irritable bowel syndrome disturbed quality of life for a subject over the past 30 days through eight sub-scales. Each item is rated on a 5-point scale ranging from 1 to 5 with higher values indicating a lower quality of life. | Four weeks after the baseline assessment | 
| Related adverse Events | An unfavorable change in the health of a participants that happens during a clinical study or within a week after the study has ended. This change may or may not be caused by the acupressure. | from the patients endorsement till one week after study completion | 
| Adherence to the to active and sham self-administered acupressure of the study. | The adherence will be calculated as percentage of planned sessions of acupressure, and adherence rate above 80% was set as a minimum requirement to be regarded as acceptable | throughout study completion, an average of 4 months | 
| use of rescue medicine | participants will be asked to report the use of rescue medicine for diarrhea or gastrointestinal symptoms | throughout study completion, an average of 4 months |