Clinical trial NCT05702255: Self- Administered Acupressure for Diarrhea Predominant Irritable Bowel Syndrome
Official title: Effect of Self- Administered Acupressure on Diarrhea Predominant Irritable Bowel Syndrome Patients' Health Outcomes: a Double Blind- Sham Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome With Diarrhea
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Baseline mean of irritable Bowel Syndrome Symptom Severity Score
timeFrame: Immediately before assigning the participants to the study groups
measure: Change from the baseline irritable Bowel Syndrome Symptom Severity Score at 2 weeks
timeFrame: after 2 weeks from the baseline
measure: Change from the baseline irritable Bowel Syndrome Symptom Severity Score at 4 weeks
timeFrame: after 4 weeks from the baseline
measure: Irritable Bowel Syndrome Adequate Relief question
timeFrame: At the baseline
measure: Irritable Bowel Syndrome Adequate Relief question
timeFrame: After 2 weeks from the baseline
measure: Irritable Bowel Syndrome Adequate Relief question
timeFrame: After 4 weeks from the baseline
measure: Mean stool frequency after 2 weeks
timeFrame: After 2 weeks from the patient endorsement
measure: Mean change of stool frequency after 4 weeks
timeFrame: After 4 weeks from the patient endorsement
measure: Stool consistency
timeFrame: at the baseline
measure: Change in the frequency of stool consistency at 2 weeks from the baseline
timeFrame: after 2 weeks from baseline
measure: Change in the frequency of stool consistency at 4 weeks from the baseline
timeFrame: after 4 weeks
Secondary outcomes:
measure: Demographic and clinical data
timeFrame: before assignment of the participants to the study groups
measure: the baseline mean of psychological distress measured by the Hospital Anxiety and Depression Scale
timeFrame: at the baseline
measure: Change from the baseline mean of the psychological distress measured by the Hospital Anxiety and Depression Scale at 4 weeks
timeFrame: after 4 weeks from the baseline
measure: Baseline mean of the quality of Life
timeFrame: at the baseline
measure: Change from the baseline mean of the quality of life at 4 weeks
timeFrame: Four weeks after the baseline assessment
measure: Related adverse Events
timeFrame: from the patients endorsement till one week after study completion
measure: Adherence to the to active and sham self-administered acupressure of the study.
timeFrame: throughout study completion, an average of 4 months
measure: use of rescue medicine
timeFrame: throughout study completion, an average of 4 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: outpatient clinics of Main University Hospital
Study officials:
affiliation: Alexandria University
name: Maha G Asal, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Zahraa H Ramzy, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Rasha F Ahmed, Phd
role: PRINCIPAL_INVESTIGATOR
References: