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

Irritable Bowel Syndrome Clinical Trial

Official title:

National Taipei University of Nursing and Health Sciences

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05042661
• Other study ID #: TFang
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: National Taipei University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: December 31, 2023
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. A patient with irritable bowel syndrome diagnosed by a doctor for at least 6 months (inclusive).

3. Communicate in Mandarin or Hokkien.

Exclusion Criteria:

1. Those who cannot take care of themselves in daily life.

2. Those who have had severe abdominal and colorectal surgery.

3. Those who have been diagnosed with inflammatory bowel disease or colorectal cancer.

4. Those with a history of mental illness, such as schizophrenia and obsessive- compulsive disorder.

5. Women who are pregnant, breastfeeding, and less than 12 months after delivery.

6. Other serious diseases, such as acute myocardial infarction, endocrine disease, decompensated cirrhosis, stroke, and end-stage renal disease, etc.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Device:
• acupuncture-like transcutaneous electrical nerve stimulation
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.

Locations

Country	Name	City	State
Taiwan	Tsu Ying Fang	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Part 1: Basic personal information:Basic and disease information list 1	gender	pretest
Other	Part 1: Basic personal information:Basic and disease information list 2	Date of birth	pretest
Other	Part 1: Basic personal information:Basic and disease information list 3	marital status	pretest
Other	Part 1: Basic personal information:Basic and disease information list 4	education level	pretest
Other	Part 1: Basic personal information:Basic and disease information list 5	Work	pretest
Other	Part 1: Basic personal information:Basic and disease information list 6	religion	pretest
Other	Part 1: Basic personal information:Basic and disease information list 7	family history	pretest
Other	Part 1: Basic personal information:Basic and disease information list 8	History of chronic disease	pretest
Other	Basic and disease information list 9	smokes	pretest
Other	Part 1: Basic personal information:Basic and disease information list 10	drink wine	pretest
Other	Part 1: Basic personal information:Basic and disease information list 11	Betel nut	pretest
Other	Part 1: Basic personal information:Basic and disease information list 12	Sleep status	pretest
Other	Part 1: Basic personal information:Basic and disease information list 13	Special eating habits	pretest
Other	Part 1: Basic personal information:Basic and disease information list 14	Exercise habits	pretest
Other	Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 1	Irritable bowel disease onset time	pretest
Other	Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 2	Bowel movement	pretest
Other	Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 3	treatment	pretest
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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