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临床试验/NCT05581355
NCT05581355已完成不适用

The Effect of Abdominal Breathing on Improving of Sleep Quality and Physiological Index Among Patients With Insomnia

National Taipei University of Nursing and Health Sciences2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2021年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
138
试验地点
2
主要终点
Pittsburgh Sleep Quality Index

研究概览

简要总结

The research topic is to explore the effectiveness of abdominal breathing on improving of sleep quality and physiological index (heart rate, respiration rate and blood pressure) among patients with insomnia. This study method adopts the research design of experimental randomized controlled trials. The persons receiving the intervention of abdominal breathing training are in the experimental group, while those who do not receive it are in the control group.

详细描述

Sleep problem is very common symptom problems, so often rely on sedative-hypnotics drugs. However, long-term dependence on drugs may bring serious side effects. Therefore, the research topic is to explore the effectiveness of abdominal breathing on improving of sleep quality and physiological index (heart rate, respiration rate and blood pressure) among patients with insomnia. This study method adopts the research design of experimental randomized controlled trials. The persons receiving the intervention of abdominal breathing training are in the experimental group, while those who do not receive it are in the control group. The research is conducted with A and B groups. Group A is for those who take sedative and sleeping medicine, and Group B is for those who do not take sedative and sleeping medicine. Both groups A and B have experimental group and control group. The effectiveness assessment will use the Pittsburgh Quality Sleep Index (PSQI) and vital signs (heart rate, breathing and blood pressure). These assessments need to complete by both the experimental group and control group. This study uses the pre-test before the implementation of abdominal breathing training, and uses the post-test at week 4 and week 8 the end of abdominal breathing training. The experimental group will receive the abdominal breathing training for a total of 8 weeks. Abdominal breathing training is carry out in the sleep center of hospital (once every 1 week, and 15 minutes every time). When the persons are at home, they will receive self-training using the abdominal breathing training video (every day 10 minutes, can include every time during the day). Moreover, the persons need to complete the "abdominal breathing training log". Hopefully, this study may develop that does not use drugs, but improves sleep quality and physiological index through abdominal breathing.

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
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Those with a total score greater than 5 points on the Pittsburgh Sleep Product Quality Table have been diagnosed with insomnia based on the Taiwan Psychiatric Association (2014) DSM-5 Psychiatric Disorder Diagnosis and Statistics, who have agreed to participate in this study and have completed a written consent form.

排除标准

  • Patients with COPD

结局指标

主要结局

Pittsburgh Sleep Quality Index

时间窗: Post-test at week 8

The total items of Pittsburgh Sleep Quality Index inventory are 7. The score of each item is from 0-3. The score\>5 points means the sleep quality is good. Meanwhile the score ≦5 points is poor sleep quality.

次要结局

  • Blood pressure(Post-test at week 8)
  • Heart rate(Post-test at week 8)
  • Respiration rate(Post-test at week 8)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xuan-Yi Huang

RN, DNSc, Professor

National Taipei University of Nursing and Health Sciences

研究点 (2)

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