National Taipei University of Nursing and Health Sciences
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- WHOQOL-BREF,Taiwan version
研究概览
简要总结
To discuss the effects of improving the irritable bowel syndrome patients' quality of life and defecation after implementing acupuncture-like Transcutaneous Electrical nerve stimulation.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: acupuncture-like transcutaneous electrical nerve stimulation (Device)
Control group:conventional therapy
The control group will receive routine care.
结局指标
主要结局
WHOQOL-BREF,Taiwan version
时间窗: 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
irritable bowel syndrome Severity Score
时间窗: 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
Irritable Bowel Syndrome Quality of Life
时间窗: 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
Bristol Stool Form Scale
时间窗: 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
WHOQOL-BREF,Taiwan version
时间窗: 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.
WHOQOL-BREF,Taiwan version
时间窗: 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
WHOQOL-BREF,Taiwan version
时间窗: 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
irritable bowel syndrome Severity Score
时间窗: 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
irritable bowel syndrome Severity Score
时间窗: 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
irritable bowel syndrome Severity Score
时间窗: 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
Irritable Bowel Syndrome Quality of Life
时间窗: 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
Irritable Bowel Syndrome Quality of Life
时间窗: 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
Irritable Bowel Syndrome Quality of Life
时间窗: 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
Bristol Stool Form Scale
时间窗: 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
Bristol Stool Form Scale
时间窗: 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
Bristol Stool Form Scale
时间窗: 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
次要结局
未报告次要终点
研究者
Tsu Ying Fang
Principal investigator
National Taipei University of Nursing and Health Sciences