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

NCT05581355 | Completed

• 1 other identifier: (849)109A-88
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

abdominal breathing; quality of sleep; physiological index; effectiveness

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (9)

• 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

Study Arms (2)

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.

Behavioral: Abdominal breathing training

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.

Interventions

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)

The effectiveness of receiving abdominal breathing training

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with COPD

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

Xuan-Yi Huang

Taipei, Peitou, 11219, Taiwan

Location

Related 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.

  PMID: 30058034 BACKGROUND

• 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. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 25581296 BACKGROUND

• 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.

  PMID: 27553981 BACKGROUND

• Chennaoui M, Arnal PJ, Sauvet F, Leger 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.

  PMID: 25127157 BACKGROUND

• 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. doi: 10.1111/j.1365-2648.2006.03858.x.

  PMID: 16796663 BACKGROUND

• Hausler 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.

  PMID: 31300205 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Xuan-Yi Huang, DNSc

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, DNSc, Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 14, 2022
• Study Start: January 14, 2021
• Primary Completion: September 13, 2021
• Study Completion: July 31, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)