Self- Administered Acupressure for Diarrhea Predominant Irritable Bowel Syndrome
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Interventions
- Other: Active acupressureOther: Sham acuptressure
- Registration Number
- NCT05702255
- Lead Sponsor
- Alexandria University
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active acupoints group Active acupressure 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. Sham acupoints group Sham acuptressure 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.
- Primary Outcome Measures
Name Time Method Change from the baseline irritable Bowel Syndrome Symptom Severity Score at 2 weeks 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 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 after 2 weeks from baseline defined by the Bristol Stool Form Scale
Baseline mean of irritable Bowel Syndrome Symptom Severity Score 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 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method Demographic and clinical data before assignment of the participants to the study groups A questionnaire will be developed to collect data about participants' age, gender, body mass index, physical activity status, diet, smoking status, medication used.
Baseline mean of the quality of Life at the baseline 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.
Change from the baseline mean of the quality of life at 4 weeks Four weeks after the baseline assessment 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.
Related adverse Events from the patients endorsement till one week after study completion 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.
use of rescue medicine throughout study completion, an average of 4 months participants will be asked to report the use of rescue medicine for diarrhea or gastrointestinal symptoms
the baseline mean of psychological distress measured by the Hospital Anxiety and Depression Scale at the baseline 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
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 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
Adherence to the to active and sham self-administered acupressure of the study. throughout study completion, an average of 4 months 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
Trial Locations
- Locations (1)
outpatient clinics of Main University Hospital
🇪🇬Alexandria, Egypt