NCT04704765

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

January 8, 2021

Last Update Submit

January 26, 2021

Conditions

Keywords

Abdominal Breathing Training, Anxiety, Effectiveness

Outcome Measures

Primary Outcomes (3)

  • Beck anxiety inventory

    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

    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

    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

Study Arms (2)

The effectiveness of receiving abdominal breathing training

EXPERIMENTAL

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.

Other: abdominal breathing training

The effectiveness of not receiving abdominal breathing training

NO INTERVENTION

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.

Interventions

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 effectiveness of receiving abdominal breathing training

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Inpatients.
  • COPD patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuan-Yi Huang

Taipei, Peitou, 11219, Taiwan

Location

Related Publications (4)

  • 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.

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

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
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, DNSc, Professor

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 12, 2021

Study Start

April 21, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations