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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05581355
• Other study ID #: (849)109A-88
• Status: Completed
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: October 2022
• Source: National Taipei University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: July 31, 2022
• Est. primary completion date: September 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Respiratory Aspiration
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Abdominal breathing training
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)

Locations

Country	Name	City	State
Taiwan	Xuan-Yi Huang	Taipei	Peitou

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

Abad VC, Guilleminault C. Insomnia in Elderly Patients: Recommendations for Pharmacological Management. Drugs Aging. 2018 Sep;35(9):791-817. doi: 10.1007/s40266-018-0569-8. Review. — View Citation

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. — View Citation

Canham SL, Rubinstein RL. Experiences of sleep and benzodiazepine use among older women. J Women Aging. 2015;27(2):123-39. doi: 10.1080/08952841.2014.928173. Epub 2015 Jan 12. — View Citation

Chen YF, Huang XY, Chien CH, Cheng JF. The Effectiveness of Diaphragmatic Breathing Relaxation Training for Reducing Anxiety. Perspect Psychiatr Care. 2017 Oct;53(4):329-336. doi: 10.1111/ppc.12184. Epub 2016 Aug 23. — View Citation

Chennaoui M, Arnal PJ, Sauvet F, Léger D. Sleep and exercise: a reciprocal issue? Sleep Med Rev. 2015 Apr;20:59-72. doi: 10.1016/j.smrv.2014.06.008. Epub 2014 Jun 30. Review. — View Citation

de Jong AE, Gamel C. Use of a simple relaxation technique in burn care: literature review. J Adv Nurs. 2006 Jun;54(6):710-21. Review. — View Citation

Häusler N, Marques-Vidal P, Haba-Rubio J, Heinzer R. Does sleep predict next-day napping or does napping influence same-day nocturnal sleep? Results of a population-based ecological momentary assessment study. Sleep Med. 2019 Sep;61:31-36. doi: 10.1016/j.sleep.2019.04.014. Epub 2019 May 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Sleep Quality Index	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.	Pre-test
Primary	Pittsburgh Sleep Quality Index	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.	Post-test at week 4
Primary	Pittsburgh Sleep Quality Index	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.	Post-test at week 8
Secondary	Heart rate	Before the abdominal breathing record the heart rate	Pre-test
Secondary	Respiration rate	Before the abdominal breathing record the respiration rate	Pre-test
Secondary	Blood pressure	Before the abdominal breathing,record the blood pressure	Pre-test
Secondary	Heart rate	After abdominal breathing for 4 weeks, and than record the heart rate	Post-test at week 4
Secondary	Respiration rate	After abdominal breathing for 4 weeks, and than record the respiration rate	Post-test at week 4
Secondary	Blood pressure	After abdominal breathing for 4 weeks, and than record the blood pressure	Post-test at week 4
Secondary	Heart rate	After abdominal breathing for 8 weeks, and than record the heart rate	Post-test at week 8
Secondary	Respiration rate	After abdominal breathing for 8 weeks, and than record the respiration rate	Post-test at week 8
Secondary	Blood pressure	After abdominal breathing for 8 weeks, and than record the blood pressure	Post-test at week 8