Acupuncture-like Transcutaneous Electrical Nerve Stimulation on Bowel Symptom and Quality of Life in Patients With Irritable Bowel Syndrome

Study Overview
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Brief Summary
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To discuss the effects of improving the irritable bowel syndrome patients' quality of life and defecation after implementing acupuncture-like Transcutaneous Electrical nerve stimulation.

Detailed Description
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This experiment will use a clinical design that will collect cases in a local teaching hospital. The way of convenience sampling will gather from the irritable bowel syndrome patients. After a questionnaire, randomly to make invention and control groups. Invention and control groups are 4 weeks and 3 weeks respectively. Each time will be for 20 minutes acupuncture-like transcutaneous electrical nerve stimulation treatment. The Control group will still have normal nursing. There will be 72 patients in two groups. The measured timing will be in the second, fourth, and eighth weeks after the prediction and invention.

Official Title
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National Taipei University of Nursing and Health Sciences

Conditions
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Acupuncture-like Transcutaneous Electrical Nerve Stimulation, Irritable Bowel Syndrome

Intervention / Treatment
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* Device: acupuncture-like transcutaneous electrical nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those who are at least 20 years old (inclusive) and are willing to sign a written informed consent after explaining the purpose of the research. A patient with irritable bowel syndrome diagnosed by a doctor for at least 6 months (inclusive). Communicate in Mandarin or Hokkien. Exclusion Criteria: Those who cannot take care of themselves in daily life. Those who have had severe abdominal and colorectal surgery. Those who have been diagnosed with inflammatory bowel disease or colorectal cancer. Those with a history of mental illness, such as schizophrenia and obsessive- compulsive disorder. Women who are pregnant, breastfeeding, and less than 12 months after delivery. Other serious diseases, such as acute myocardial infarction, endocrine disease, decompensated cirrhosis, stroke, and end-stage renal disease, etc.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture-like transcutaneous electrical nerve stimulation<br>The experimental group received acupuncture-like transcutaneous electrical nerve stimulation three times a week for 4 weeks. Invention and control groups are 4 weeks and 3 weeks respectively. Each time will be for 20 minutes acupuncture-like transcutaneous electrical nerve stimulation treatment | Device: acupuncture-like transcutaneous electrical nerve stimulation<br>* The intervention group performed Al-TENS therapy 3 times a week for at least 20 minutes each time for 4 consecutive weeks. The second, fourth, and eighth week after the intervention.<br>|
| No Intervention: Control group:conventional therapy<br>The control group will receive routine care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHOQOL-BREF,Taiwan version | There are a total of 28 questions on this scale, of which 26 are common questions around the world, and the other 2 are local questions. This questionnaire is a positive question and a five-point scoring system. The higher the score, the better the quality of life. | pretest | 
| WHOQOL-BREF,Taiwan version | There are a total of 28 questions on this scale, of which 26 are common questions around the world, and the other 2 are local questions. This questionnaire is a positive question and a five-point scoring system. The higher the score, the better the quality of life | 2 weeks after the pretest | 
| WHOQOL-BREF,Taiwan version | There are a total of 28 questions on this scale, of which 26 are common questions around the world, and the other 2 are local questions. This questionnaire is a positive question and a five-point scoring system. The higher the score, the better the quality of life | 4 weeks after the pretest | 
| WHOQOL-BREF,Taiwan version | There are a total of 28 questions on this scale, of which 26 are common questions around the world, and the other 2 are local questions. This questionnaire is a positive question and a five-point scoring system. The higher the score, the better the quality of life | 8 weeks after the pretest | 
| irritable bowel syndrome Severity Score | There are a total of 5 questions on this scale. This questionnaire is a positive question type. The score of each item can be from 0 to 100. Therefore, the overall severity of IBS ranges from 0 to 500. The severity of symptoms can be divided into mild; moderate; severe, the higher the score, the more severe the IBS symptoms | pretest | 
| irritable bowel syndrome Severity Score | There are a total of 5 questions on this scale. This questionnaire is a positive question type. The score of each item can be from 0 to 100. Therefore, the overall severity of IBS ranges from 0 to 500. The severity of symptoms can be divided into mild; moderate; severe, the higher the score, the more severe the IBS symptoms | 2 weeks after the pretest | 
| irritable bowel syndrome Severity Score | There are a total of 5 questions on this scale. This questionnaire is a positive question type. The score of each item can be from 0 to 100. Therefore, the overall severity of IBS ranges from 0 to 500. The severity of symptoms can be divided into mild; moderate; severe, the higher the score, the more severe the IBS symptoms | 4 weeks after the pretest | 
| irritable bowel syndrome Severity Score | There are a total of 5 questions on this scale. This questionnaire is a positive question type. The score of each item can be from 0 to 100. Therefore, the overall severity of IBS ranges from 0 to 500. The severity of symptoms can be divided into mild; moderate; severe, the higher the score, the more severe the IBS symptoms | 8 weeks after the pretest | 
| Irritable Bowel Syndrome Quality of Life | This questionnaire has a total of 34 questions, all of which are positive questions, and are scored with five points, divided into 1 point = completely no, 2 points = a little bit, 3 points = medium, 4 points = equivalent, 5 points = extreme. The score range is 34 170 points, the higher the score, the worse the quality of life | pretest | 
| Irritable Bowel Syndrome Quality of Life | This questionnaire has a total of 34 questions, all of which are positive questions, and are scored with five points, divided into 1 point = completely no, 2 points = a little bit, 3 points = medium, 4 points = equivalent, 5 points = extreme. The score range is 34 170 points, the higher the score, the worse the quality of life | 2 weeks after the pretest | 
| Irritable Bowel Syndrome Quality of Life | This questionnaire has a total of 34 questions, all of which are positive questions, and are scored with five points, divided into 1 point = completely no, 2 points = a little bit, 3 points = medium, 4 points = equivalent, 5 points = extreme. The score range is 34 170 points, the higher the score, the worse the quality of life | 4 weeks after the pretest | 
| Irritable Bowel Syndrome Quality of Life | This questionnaire has a total of 34 questions, all of which are positive questions, and are scored with five points, divided into 1 point = completely no, 2 points = a little bit, 3 points = medium, 4 points = equivalent, 5 points = extreme. The score range is 34 170 points, the higher the score, the worse the quality of life | 8 weeks after the pretest | 
| Bristol Stool Form Scale | The first and second types of stool show that the patient has constipation, the first type is more serious than the second type; the normal stool types are the third and fourth types, and the fifth to seventh types are suspected Diarrhea (Lewis, & Heaton, 1997), the above description indicates that the lower the score, the more severe the constipation symptoms, and vice versa, the more severe the diarrhea symptoms | pretest | 
| Bristol Stool Form Scale | The first and second types of stool show that the patient has constipation, the first type is more serious than the second type; the normal stool types are the third and fourth types, and the fifth to seventh types are suspected Diarrhea (Lewis, & Heaton, 1997), the above description indicates that the lower the score, the more severe the constipation symptoms, and vice versa, the more severe the diarrhea symptoms | 2 weeks after the pretest | 
| Bristol Stool Form Scale | The first and second types of stool show that the patient has constipation, the first type is more serious than the second type; the normal stool types are the third and fourth types, and the fifth to seventh types are suspected Diarrhea (Lewis, & Heaton, 1997), the above description indicates that the lower the score, the more severe the constipation symptoms, and vice versa, the more severe the diarrhea symptoms | 4 weeks after the pretest | 
| Bristol Stool Form Scale | The first and second types of stool show that the patient has constipation, the first type is more serious than the second type; the normal stool types are the third and fourth types, and the fifth to seventh types are suspected Diarrhea (Lewis, & Heaton, 1997), the above description indicates that the lower the score, the more severe the constipation symptoms, and vice versa, the more severe the diarrhea symptoms | 8 weeks after the pretest | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irritable bowel syndrome, acupuncture-like transcutaneous electrical nervestimulation, quality of life