Irritable Bowel Syndrome With Diarrhea
Conditions
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
Interventions
OTHERActive acupressure
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
OTHERSham acuptressure
The same protocol as the active acupressure group.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| Irritable Bowel Syndrome Adequate Relief question | At 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| 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 |
| 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. |
Countries
Egypt
Outcome results
None listed