Back to resultsAcupuncture-like Transcutaneous Electrical Nerve Stimulation on Bowel Symptom and Quality of Life in Patients With Irritable Bowel Syndrome
Primary Purpose
Acupuncture-like Transcutaneous Electrical Nerve Stimulation, Irritable Bowel Syndrome
Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture-like transcutaneous electrical nerve stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Acupuncture-like Transcutaneous Electrical Nerve Stimulation focused on measuring irritable bowel syndrome, acupuncture-like transcutaneous electrical nervestimulation, quality of life
Eligibility Criteria
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.
Sites / Locations
- Tsu Ying Fang
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
acupuncture-like transcutaneous electrical nerve stimulation
Control group:conventional therapy
Arm Description
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
The control group will receive routine care.
Outcomes
Primary Outcome Measures
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05042661
First Posted
September 4, 2021
Last Updated
October 1, 2022
Sponsor
National Taipei University of Nursing and Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05042661
Brief Title
Acupuncture-like Transcutaneous Electrical Nerve Stimulation on Bowel Symptom and Quality of Life in Patients With Irritable Bowel Syndrome
Official Title
National Taipei University of Nursing and Health Sciences
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture-like Transcutaneous Electrical Nerve Stimulation, Irritable Bowel Syndrome
Keywords
irritable bowel syndrome, acupuncture-like transcutaneous electrical nervestimulation, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acupuncture-like transcutaneous electrical nerve stimulation
Arm Type
Experimental
Arm Description
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
Arm Title
Control group:conventional therapy
Arm Type
No Intervention
Arm Description
The control group will receive routine care.
Intervention Type
Device
Intervention Name(s)
acupuncture-like transcutaneous electrical nerve stimulation
Intervention 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.
Primary Outcome Measure Information:
Title
WHOQOL-BREF,Taiwan version
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.
Time Frame
pretest
Title
WHOQOL-BREF,Taiwan version
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
Time Frame
2 weeks after the pretest
Title
WHOQOL-BREF,Taiwan version
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
Time Frame
4 weeks after the pretest
Title
WHOQOL-BREF,Taiwan version
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
Time Frame
8 weeks after the pretest
Title
irritable bowel syndrome Severity Score
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
Time Frame
pretest
Title
irritable bowel syndrome Severity Score
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
Time Frame
2 weeks after the pretest
Title
irritable bowel syndrome Severity Score
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
Time Frame
4 weeks after the pretest
Title
irritable bowel syndrome Severity Score
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
Time Frame
8 weeks after the pretest
Title
Irritable Bowel Syndrome Quality of Life
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
Time Frame
pretest
Title
Irritable Bowel Syndrome Quality of Life
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
Time Frame
2 weeks after the pretest
Title
Irritable Bowel Syndrome Quality of Life
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
Time Frame
4 weeks after the pretest
Title
Irritable Bowel Syndrome Quality of Life
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
Time Frame
8 weeks after the pretest
Title
Bristol Stool Form Scale
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
Time Frame
pretest
Title
Bristol Stool Form Scale
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
Time Frame
2 weeks after the pretest
Title
Bristol Stool Form Scale
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
Time Frame
4 weeks after the pretest
Title
Bristol Stool Form Scale
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
Time Frame
8 weeks after the pretest
Other Pre-specified Outcome Measures:
Title
Part 1: Basic personal information:Basic and disease information list 1
Description
gender
Time Frame
pretest
Title
Part 1: Basic personal information:Basic and disease information list 2
Description
Date of birth
Time Frame
pretest
Title
Part 1: Basic personal information:Basic and disease information list 3
Description
marital status
Time Frame
pretest
Title
Part 1: Basic personal information:Basic and disease information list 4
Description
education level
Time Frame
pretest
Title
Part 1: Basic personal information:Basic and disease information list 5
Description
Work
Time Frame
pretest
Title
Part 1: Basic personal information:Basic and disease information list 6
Description
religion
Time Frame
pretest
Title
Part 1: Basic personal information:Basic and disease information list 7
Description
family history
Time Frame
pretest
Title
Part 1: Basic personal information:Basic and disease information list 8
Description
History of chronic disease
Time Frame
pretest
Title
Basic and disease information list 9
Description
smokes
Time Frame
pretest
Title
Part 1: Basic personal information:Basic and disease information list 10
Description
drink wine
Time Frame
pretest
Title
Part 1: Basic personal information:Basic and disease information list 11
Description
Betel nut
Time Frame
pretest
Title
Part 1: Basic personal information:Basic and disease information list 12
Description
Sleep status
Time Frame
pretest
Title
Part 1: Basic personal information:Basic and disease information list 13
Description
Special eating habits
Time Frame
pretest
Title
Part 1: Basic personal information:Basic and disease information list 14
Description
Exercise habits
Time Frame
pretest
Title
Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 1
Description
Irritable bowel disease onset time
Time Frame
pretest
Title
Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 2
Description
Bowel movement
Time Frame
pretest
Title
Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 3
Description
treatment
Time Frame
pretest
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Tsu Ying Fang
City
New Taipei City
ZIP/Postal Code
237
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Acupuncture-like Transcutaneous Electrical Nerve Stimulation on Bowel Symptom and Quality of Life in Patients With Irritable Bowel Syndrome
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