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Clinical Trials/NCT05581355
NCT05581355CompletedNot Applicable

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

National Taipei University of Nursing and Health Sciences1 site in 1 country138 target enrollmentStarted: January 14, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
138
Locations
1
Primary Endpoint
Pittsburgh Sleep Quality Index

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •Patients with COPD

Arms & Interventions

The effectiveness of receiving abdominal breathing training

Experimental

Training for 8 weeks (1 time a week, 15 minutes each time). Performed one-on-one by a trainer in a sleep center. At home, you can use the abdominal breathing training video to train yourself (10 minutes a day, can be divided into 10 minutes), and you need to fill in the abdominal breathing training log.

Intervention: Abdominal breathing training (Behavioral)

The effectiveness of not receiving abdominal breathing training

No Intervention

The trainer does not provide abdominal breathing training, does not perform abdominal breathing exercises at home, and does not need to fill in abdominal breathing training logs.

Outcomes

Primary Outcomes

Pittsburgh Sleep Quality Index

Time Frame: 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.

Pittsburgh Sleep Quality Index

Time Frame: Pre-test

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.

Pittsburgh Sleep Quality Index

Time Frame: Post-test at week 4

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.

Secondary Outcomes

  • Blood pressure(Post-test at week 8)
  • Heart rate(Post-test at week 8)
  • Respiration rate(Post-test at week 8)
  • Heart rate(Pre-test)
  • Respiration rate(Pre-test)
  • Blood pressure(Pre-test)
  • Heart rate(Post-test at week 4)
  • Respiration rate(Post-test at week 4)
  • Blood pressure(Post-test at week 4)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xuan-Yi Huang

RN, DNSc, Professor

National Taipei University of Nursing and Health Sciences

Study Sites (1)

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