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NCT Number: NCT05581355

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

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuan-Yi Huang

Taipei, Peitou, 11219, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abdominal breathing training

Behavioral

In the sleep center, it is carried out in a one-on-one manner by the trainer. At home, self-training through abdominal breathing training videos (10 minutes per day, you can accumulate up to 10 minutes in divided doses)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Heart rate

    Time frame: Pre-test

    Before the abdominal breathing record the heart rate

  2. Respiration rate

    Time frame: Pre-test

    Before the abdominal breathing record the respiration rate

  3. Blood pressure

    Time frame: Pre-test

    Before the abdominal breathing,record the blood pressure

  4. Heart rate

    Time frame: Post-test at week 4

    After abdominal breathing for 4 weeks, and than record the heart rate

  5. Respiration rate

    Time frame: Post-test at week 4

    After abdominal breathing for 4 weeks, and than record the respiration rate

  6. Blood pressure

    Time frame: Post-test at week 4

    After abdominal breathing for 4 weeks, and than record the blood pressure

  7. Heart rate

    Time frame: Post-test at week 8

    After abdominal breathing for 8 weeks, and than record the heart rate

  8. Respiration rate

    Time frame: Post-test at week 8

    After abdominal breathing for 8 weeks, and than record the respiration rate

  9. Blood pressure

    Time frame: Post-test at week 8

    After abdominal breathing for 8 weeks, and than record the blood pressure

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Oct 14, 2022
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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