Clinical trial NCT05042661: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture-like Transcutaneous Electrical Nerve Stimulation
Irritable Bowel Syndrome
Keywords: irritable bowel syndrome
acupuncture-like transcutaneous electrical nervestimulation
quality of life
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: WHOQOL-BREF,Taiwan version
timeFrame: pretest
measure: WHOQOL-BREF,Taiwan version
timeFrame: 2 weeks after the pretest
measure: WHOQOL-BREF,Taiwan version
timeFrame: 4 weeks after the pretest
measure: WHOQOL-BREF,Taiwan version
timeFrame: 8 weeks after the pretest
measure: irritable bowel syndrome Severity Score
timeFrame: pretest
measure: irritable bowel syndrome Severity Score
timeFrame: 2 weeks after the pretest
measure: irritable bowel syndrome Severity Score
timeFrame: 4 weeks after the pretest
measure: irritable bowel syndrome Severity Score
timeFrame: 8 weeks after the pretest
measure: Irritable Bowel Syndrome Quality of Life
timeFrame: pretest
measure: Irritable Bowel Syndrome Quality of Life
timeFrame: 2 weeks after the pretest
measure: Irritable Bowel Syndrome Quality of Life
timeFrame: 4 weeks after the pretest
measure: Irritable Bowel Syndrome Quality of Life
timeFrame: 8 weeks after the pretest
measure: Bristol Stool Form Scale
timeFrame: pretest
measure: Bristol Stool Form Scale
timeFrame: 2 weeks after the pretest
measure: Bristol Stool Form Scale
timeFrame: 4 weeks after the pretest
measure: Bristol Stool Form Scale
timeFrame: 8 weeks after the pretest
Secondary outcomes:
Other outcomes:
measure: Part 1: Basic personal information:Basic and disease information list 1
timeFrame: pretest
measure: Part 1: Basic personal information:Basic and disease information list 2
timeFrame: pretest
measure: Part 1: Basic personal information:Basic and disease information list 3
timeFrame: pretest
measure: Part 1: Basic personal information:Basic and disease information list 4
timeFrame: pretest
measure: Part 1: Basic personal information:Basic and disease information list 5
timeFrame: pretest
measure: Part 1: Basic personal information:Basic and disease information list 6
timeFrame: pretest
measure: Part 1: Basic personal information:Basic and disease information list 7
timeFrame: pretest
measure: Part 1: Basic personal information:Basic and disease information list 8
timeFrame: pretest
measure: Basic and disease information list 9
timeFrame: pretest
measure: Part 1: Basic personal information:Basic and disease information list 10
timeFrame: pretest
measure: Part 1: Basic personal information:Basic and disease information list 11
timeFrame: pretest
measure: Part 1: Basic personal information:Basic and disease information list 12
timeFrame: pretest
measure: Part 1: Basic personal information:Basic and disease information list 13
timeFrame: pretest
measure: Part 1: Basic personal information:Basic and disease information list 14
timeFrame: pretest
measure: Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 1
timeFrame: pretest
measure: Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 2
timeFrame: pretest
measure: Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 3
timeFrame: pretest
Locations:
city: New Taipei City
country: Taiwan
facility: Tsu Ying Fang
Study officials:
References: