- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04704765
Abdominal Breathing Training on Reducing Anxiety
January 26, 2021 updated by: Xuan-Yi Huang, National Taipei University of Nursing and Health Sciences
The Effectiveness of Abdominal Breathing Training on Reducing Anxiety
The research purpose is to investigate the effectiveness of abdominal breathing training on reducing anxiety.
This study is an experimental research design.
Using a randomized controlled trial approach.
The patients receiving the intervention of abdominal breathing training were in the experimental group, while those who did not receive it were in the control group.
Study Overview
Detailed Description
The aim of the study is to investigate the effectiveness of the abdominal breathing training on reducing anxiety.
Using an experimental randomized controlled trial approach.
The experimental group receiving abdominal breathing training, and control group without training.
The effectiveness assessment used the Beck anxiety inventory, required to be completed by both the experimental group and control group.
This study performed the pre-and-post assessments.
This study performed the pre-test before the implementation of abdominal breathing training, and performed the post-test at Week 4 and Week 8 the end of abdominal breathing training.
During this period, they received the abdominal breathing training at the outpatient clinic (every day 30 minutes, can include every time during the day).
When the subjects were at home, they received self-training using the abdominal breathing training video (once every day and 30 minutes every time).
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Peitou
-
Taipei, Peitou, Taiwan, 11219
- Xuan-Yi Huang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Who are over 20 years old.
- The score of Beck anxiety inventory at lease of 8.
- Agree to participate in the study and have filled out a written consent form.
Exclusion Criteria:
- Inpatients.
- COPD patients.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The effectiveness of receiving abdominal breathing training
The patients receiving the intervention of abdominal breathing training were in the experimental group.
The experimental group received the abdominal breathing training for a total of 8 weeks.
During this period, they received the abdominal breathing training at the outpatient clinic (every day 30 minutes, can include every time during the day).
When the subjects were at home, they received self-training using the abdominal breathing training video (once every day and 30 minutes every time).
The control group without training.
|
The abdominal breathing training at the outpatient clinic (every day 30 minutes, can include every time during the day).
When the subjects were at home, they received self-training using the abdominal breathing training video (once every day and 30 minutes every time).
|
No Intervention: The effectiveness of not receiving abdominal breathing training
The control group who did not receive abdominal breathing training.
The effectiveness assessment used the Beck anxiety inventory and physiological index (heart beats, breath and blood pressure), required to be completed by the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck anxiety inventory
Time Frame: pretest
|
The total items of Beck anxiety inventory are 21.
The score of each item is from 0-3.
The score 0-7 is the least mild anxiety, 8-15 is the mild anxiety, 16-25 is the moderate anxiety, and 26-63 is the severe anxiety
|
pretest
|
Beck anxiety inventory
Time Frame: post-test at Week 4
|
The total items of Beck anxiety inventory are 21.
The score of each item is from 0-3.
The score 0-7 is the least mild anxiety, 8-15 is the mild anxiety, 16-25 is the moderate anxiety, and 26-63 is the severe anxiety
|
post-test at Week 4
|
Beck anxiety inventory
Time Frame: post-test at Week 8
|
The total items of Beck anxiety inventory are 21.
The score of each item is from 0-3.
The score 0-7 is the least mild anxiety, 8-15 is the mild anxiety, 16-25 is the moderate anxiety, and 26-63 is the severe anxiety
|
post-test at Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xuan-Yi Huang, DNSc, National Taipei University of Nursing and Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cahalin LP, Braga M, Matsuo Y, Hernandez ED. Efficacy of diaphragmatic breathing in persons with chronic obstructive pulmonary disease: a review of the literature. J Cardiopulm Rehabil. 2002 Jan-Feb;22(1):7-21. doi: 10.1097/00008483-200201000-00002.
- 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.
- Gosselink RA, Wagenaar RC, Rijswijk H, Sargeant AJ, Decramer ML. Diaphragmatic breathing reduces efficiency of breathing in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1995 Apr;151(4):1136-42. doi: 10.1164/ajrccm.151.4.7697243.
- Hopper SI, Murray SL, Ferrara LR, Singleton JK. Effectiveness of diaphragmatic breathing for reducing physiological and psychological stress in adults: a quantitative systematic review. JBI Database System Rev Implement Rep. 2019 Sep;17(9):1855-1876. doi: 10.11124/JBISRIR-2017-003848.
Helpful Links
- This article reviews the literature regarding the efficacy of DB in persons with chronic obstructive pulmonary disease (COPD), and reports on the beneficial and detrimental effects of DB in persons with COPD.
- The findings provide guidance for providing quality care that effectively reduces the anxiety level of care recipients in clinical and community settings.
- Tidal volume, respiratory frequency, and duty cycle did not change significantly during diaphragmatic breathing. Dyspnea sensation tended to increase during diaphragmatic breathing.
- The evidence suggests that diaphragmatic breathing may decrease stress as measured by physiologic biomarkers, as well psychological self-report tools.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 21, 2020
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
January 8, 2021
First Submitted That Met QC Criteria
January 8, 2021
First Posted (Actual)
January 12, 2021
Study Record Updates
Last Update Posted (Actual)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200105R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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