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

Sponsor
National Taipei University of Nursing and Health Sciences (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05042661
Collaborator
(none)
72
1
2
10.9
6.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: acupuncture-like transcutaneous electrical nerve stimulation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
National Taipei University of Nursing and Health Sciences
Actual Study Start Date :
Feb 1, 2021
Actual Primary Completion Date :
Feb 1, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: acupuncture-like transcutaneous electrical nerve stimulation

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
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.

No Intervention: Control group:conventional therapy

The control group will receive routine care.

Outcome Measures

Primary Outcome Measures

  1. WHOQOL-BREF,Taiwan version [pretest]

    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. WHOQOL-BREF,Taiwan version [2 weeks after the pretest]

    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

  3. WHOQOL-BREF,Taiwan version [4 weeks after the pretest]

    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. WHOQOL-BREF,Taiwan version [8 weeks after the pretest]

    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

  5. irritable bowel syndrome Severity Score [pretest]

    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

  6. irritable bowel syndrome Severity Score [2 weeks after the pretest]

    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

  7. irritable bowel syndrome Severity Score [4 weeks after the pretest]

    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. irritable bowel syndrome Severity Score [8 weeks after the pretest]

    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

  9. Irritable Bowel Syndrome Quality of Life [pretest]

    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

  10. Irritable Bowel Syndrome Quality of Life [2 weeks after the pretest]

    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

  11. Irritable Bowel Syndrome Quality of Life [4 weeks after the pretest]

    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

  12. Irritable Bowel Syndrome Quality of Life [8 weeks after the pretest]

    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

  13. Bristol Stool Form Scale [pretest]

    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

  14. Bristol Stool Form Scale [2 weeks after the pretest]

    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

  15. Bristol Stool Form Scale [4 weeks after the pretest]

    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

  16. Bristol Stool Form Scale [8 weeks after the pretest]

    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

Other Outcome Measures

  1. Part 1: Basic personal information:Basic and disease information list 1 [pretest]

    gender

  2. Part 1: Basic personal information:Basic and disease information list 2 [pretest]

    Date of birth

  3. Part 1: Basic personal information:Basic and disease information list 3 [pretest]

    marital status

  4. Part 1: Basic personal information:Basic and disease information list 4 [pretest]

    education level

  5. Part 1: Basic personal information:Basic and disease information list 5 [pretest]

    Work

  6. Part 1: Basic personal information:Basic and disease information list 6 [pretest]

    religion

  7. Part 1: Basic personal information:Basic and disease information list 7 [pretest]

    family history

  8. Part 1: Basic personal information:Basic and disease information list 8 [pretest]

    History of chronic disease

  9. Basic and disease information list 9 [pretest]

    smokes

  10. Part 1: Basic personal information:Basic and disease information list 10 [pretest]

    drink wine

  11. Part 1: Basic personal information:Basic and disease information list 11 [pretest]

    Betel nut

  12. Part 1: Basic personal information:Basic and disease information list 12 [pretest]

    Sleep status

  13. Part 1: Basic personal information:Basic and disease information list 13 [pretest]

    Special eating habits

  14. Part 1: Basic personal information:Basic and disease information list 14 [pretest]

    Exercise habits

  15. Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 1 [pretest]

    Irritable bowel disease onset time

  16. Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 2 [pretest]

    Bowel movement

  17. Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 3 [pretest]

    treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tsu Ying Fang New Taipei City Taiwan 237

Sponsors and Collaborators

  • National Taipei University of Nursing and Health Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tsu Ying Fang, Principal investigator, National Taipei University of Nursing and Health Sciences
ClinicalTrials.gov Identifier:
NCT05042661
Other Study ID Numbers:
  • TFang
First Posted:
Sep 13, 2021
Last Update Posted:
Sep 13, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tsu Ying Fang, Principal investigator, National Taipei University of Nursing and Health Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2021