Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2025-12-27 @ 10:33 PM
Study NCT ID:
NCT05042661
Status:
UNKNOWN
Last Update Posted:
2022-10-04
First Post:
2021-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture-like Transcutaneous Electrical Nerve Stimulation on Bowel Symptom and Quality of Life in Patients With Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-01', 'studyFirstSubmitDate': '2021-09-04', 'studyFirstSubmitQcDate': '2021-09-04', 'lastUpdatePostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Part 1: Basic personal information:Basic and disease information list 1', 'timeFrame': 'pretest', 'description': 'gender'}, {'measure': 'Part 1: Basic personal information:Basic and disease information list 2', 'timeFrame': 'pretest', 'description': 'Date of birth'}, {'measure': 'Part 1: Basic personal information:Basic and disease information list 3', 'timeFrame': 'pretest', 'description': 'marital status'}, {'measure': 'Part 1: Basic personal information:Basic and disease information list 4', 'timeFrame': 'pretest', 'description': 'education level'}, {'measure': 'Part 1: Basic personal information:Basic and disease information list 5', 'timeFrame': 'pretest', 'description': 'Work'}, {'measure': 'Part 1: Basic personal information:Basic and disease information list 6', 'timeFrame': 'pretest', 'description': 'religion'}, {'measure': 'Part 1: Basic personal information:Basic and disease information list 7', 'timeFrame': 'pretest', 'description': 'family history'}, {'measure': 'Part 1: Basic personal information:Basic and disease information list 8', 'timeFrame': 'pretest', 'description': 'History of chronic disease'}, {'measure': 'Basic and disease information list 9', 'timeFrame': 'pretest', 'description': 'smokes'}, {'measure': 'Part 1: Basic personal information:Basic and disease information list 10', 'timeFrame': 'pretest', 'description': 'drink wine'}, {'measure': 'Part 1: Basic personal information:Basic and disease information list 11', 'timeFrame': 'pretest', 'description': 'Betel nut'}, {'measure': 'Part 1: Basic personal information:Basic and disease information list 12', 'timeFrame': 'pretest', 'description': 'Sleep status'}, {'measure': 'Part 1: Basic personal information:Basic and disease information list 13', 'timeFrame': 'pretest', 'description': 'Special eating habits'}, {'measure': 'Part 1: Basic personal information:Basic and disease information list 14', 'timeFrame': 'pretest', 'description': 'Exercise habits'}, {'measure': 'Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 1', 'timeFrame': 'pretest', 'description': 'Irritable bowel disease onset time'}, {'measure': 'Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 2', 'timeFrame': 'pretest', 'description': 'Bowel movement'}, {'measure': 'Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 3', 'timeFrame': 'pretest', 'description': 'treatment'}], 'primaryOutcomes': [{'measure': 'WHOQOL-BREF,Taiwan version', 'timeFrame': 'pretest', 'description': '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.'}, {'measure': 'WHOQOL-BREF,Taiwan version', 'timeFrame': '2 weeks after the pretest', 'description': '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'}, {'measure': 'WHOQOL-BREF,Taiwan version', 'timeFrame': '4 weeks after the pretest', 'description': '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'}, {'measure': 'WHOQOL-BREF,Taiwan version', 'timeFrame': '8 weeks after the pretest', 'description': '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'}, {'measure': 'irritable bowel syndrome Severity Score', 'timeFrame': 'pretest', 'description': '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'}, {'measure': 'irritable bowel syndrome Severity Score', 'timeFrame': '2 weeks after the pretest', 'description': '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'}, {'measure': 'irritable bowel syndrome Severity Score', 'timeFrame': '4 weeks after the pretest', 'description': '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'}, {'measure': 'irritable bowel syndrome Severity Score', 'timeFrame': '8 weeks after the pretest', 'description': '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'}, {'measure': 'Irritable Bowel Syndrome Quality of Life', 'timeFrame': 'pretest', 'description': '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'}, {'measure': 'Irritable Bowel Syndrome Quality of Life', 'timeFrame': '2 weeks after the pretest', 'description': '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'}, {'measure': 'Irritable Bowel Syndrome Quality of Life', 'timeFrame': '4 weeks after the pretest', 'description': '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'}, {'measure': 'Irritable Bowel Syndrome Quality of Life', 'timeFrame': '8 weeks after the pretest', 'description': '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'}, {'measure': 'Bristol Stool Form Scale', 'timeFrame': 'pretest', 'description': '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'}, {'measure': 'Bristol Stool Form Scale', 'timeFrame': '2 weeks after the pretest', 'description': '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'}, {'measure': 'Bristol Stool Form Scale', 'timeFrame': '4 weeks after the pretest', 'description': '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'}, {'measure': 'Bristol Stool Form Scale', 'timeFrame': '8 weeks after the pretest', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['irritable bowel syndrome', 'acupuncture-like transcutaneous electrical nervestimulation', 'quality of life'], 'conditions': ['Acupuncture-like Transcutaneous Electrical Nerve Stimulation', 'Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': "To discuss the effects of improving the irritable bowel syndrome patients' quality of life and defecation after implementing acupuncture-like Transcutaneous Electrical nerve stimulation.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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.\n2. A patient with irritable bowel syndrome diagnosed by a doctor for at least 6 months (inclusive).\n3. Communicate in Mandarin or Hokkien.\n\nExclusion Criteria:\n\n1. Those who cannot take care of themselves in daily life.\n2. Those who have had severe abdominal and colorectal surgery.\n3. Those who have been diagnosed with inflammatory bowel disease or colorectal cancer.\n4. Those with a history of mental illness, such as schizophrenia and obsessive- compulsive disorder.\n5. Women who are pregnant, breastfeeding, and less than 12 months after delivery.\n6. Other serious diseases, such as acute myocardial infarction, endocrine disease, decompensated cirrhosis, stroke, and end-stage renal disease, etc.'}, 'identificationModule': {'nctId': 'NCT05042661', 'briefTitle': 'Acupuncture-like Transcutaneous Electrical Nerve Stimulation on Bowel Symptom and Quality of Life in Patients With Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'National Taipei University of Nursing and Health Sciences'}, 'officialTitle': 'National Taipei University of Nursing and Health Sciences', 'orgStudyIdInfo': {'id': 'TFang'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'acupuncture-like transcutaneous electrical nerve stimulation', 'description': '1. The experimental group received acupuncture-like transcutaneous electrical nerve stimulation three times a week for 4 weeks.\n2. 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', 'interventionNames': ['Device: acupuncture-like transcutaneous electrical nerve stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'Control group:conventional therapy', 'description': 'The control group will receive routine care.'}], 'interventions': [{'name': 'acupuncture-like transcutaneous electrical nerve stimulation', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['acupuncture-like transcutaneous electrical nerve stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '237', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Tsu Ying Fang', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taipei University of Nursing and Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Tsu Ying Fang', 'investigatorAffiliation': 'National Taipei University of Nursing and Health Sciences'}}}}