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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
70
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
The same protocol as the active acupressure group.
outpatient clinics of Main University Hospital
Alexandria, Egypt
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: At the baseline
Irritable Bowel Syndrome Adequate Relief question
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: at the baseline
Change in the frequency of stool consistency at 2 weeks from the baseline
defined by the Bristol Stool Form Scale
Time frame: 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
Time frame: after 4 weeks
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: throughout study completion, an average of 4 months