search
Back to results

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

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Abdominal breathing training
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring abdominal breathing, quality of sleep, physiological index, effectiveness

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Xuan-Yi Huang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The effectiveness of receiving abdominal breathing training

The effectiveness of not receiving abdominal breathing training

Arm Description

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.

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 Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Heart rate
Before the abdominal breathing record the heart rate
Respiration rate
Before the abdominal breathing record the respiration rate
Blood pressure
Before the abdominal breathing,record the blood pressure
Heart rate
After abdominal breathing for 4 weeks, and than record the heart rate
Respiration rate
After abdominal breathing for 4 weeks, and than record the respiration rate
Blood pressure
After abdominal breathing for 4 weeks, and than record the blood pressure
Heart rate
After abdominal breathing for 8 weeks, and than record the heart rate
Respiration rate
After abdominal breathing for 8 weeks, and than record the respiration rate
Blood pressure
After abdominal breathing for 8 weeks, and than record the blood pressure

Full Information

First Posted
September 28, 2022
Last Updated
October 12, 2022
Sponsor
National Taipei University of Nursing and Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT05581355
Brief Title
Abdominal Breathing on Improving of Sleep Quality and Physiological Index Among Patients With Insomnia
Official Title
The Effect of Abdominal Breathing on Improving of Sleep Quality and Physiological Index Among Patients With Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
September 13, 2021 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
abdominal breathing, quality of sleep, physiological index, effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The effectiveness of receiving abdominal breathing training
Arm Type
Experimental
Arm Description
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.
Arm Title
The effectiveness of not receiving abdominal breathing training
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Abdominal breathing training
Intervention Description
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 Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
Pre-test
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
Post-test at week 4
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
Post-test at week 8
Secondary Outcome Measure Information:
Title
Heart rate
Description
Before the abdominal breathing record the heart rate
Time Frame
Pre-test
Title
Respiration rate
Description
Before the abdominal breathing record the respiration rate
Time Frame
Pre-test
Title
Blood pressure
Description
Before the abdominal breathing,record the blood pressure
Time Frame
Pre-test
Title
Heart rate
Description
After abdominal breathing for 4 weeks, and than record the heart rate
Time Frame
Post-test at week 4
Title
Respiration rate
Description
After abdominal breathing for 4 weeks, and than record the respiration rate
Time Frame
Post-test at week 4
Title
Blood pressure
Description
After abdominal breathing for 4 weeks, and than record the blood pressure
Time Frame
Post-test at week 4
Title
Heart rate
Description
After abdominal breathing for 8 weeks, and than record the heart rate
Time Frame
Post-test at week 8
Title
Respiration rate
Description
After abdominal breathing for 8 weeks, and than record the respiration rate
Time Frame
Post-test at week 8
Title
Blood pressure
Description
After abdominal breathing for 8 weeks, and than record the blood pressure
Time Frame
Post-test at week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuan-Yi Huang, DNSc
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuan-Yi Huang
City
Taipei
State/Province
Peitou
ZIP/Postal Code
11219
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30058034
Citation
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.
Results Reference
background
PubMed Identifier
2748771
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. doi: 10.1016/0165-1781(89)90047-4.
Results Reference
background
PubMed Identifier
25581296
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.
Results Reference
background
PubMed Identifier
27553981
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.
Results Reference
background
PubMed Identifier
25127157
Citation
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.
Results Reference
background
PubMed Identifier
16796663
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. doi: 10.1111/j.1365-2648.2006.03858.x.
Results Reference
background
PubMed Identifier
31300205
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs