NCT04910932

Brief Summary

It has been reported that in the first stages of the pandemic, a significant portion of the general population experienced psychological problems such as anxiety, depression and post-traumatic disorders. These problems persist today. A balanced diet, physical activity participation and relaxation techniques are recommended for preventing such problems. In studies conducted before the pandemic, it is reported that breathing exercises have positive effects on anxiety, sleep and quality of life in both patients and healthy individuals. Aim of this study is to investigate the effects of breathing exercises applied via teleconference on fear of COVID-19, anxiety, sleep and quality of life in healthy adult population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

June 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2021

Completed
Last Updated

March 9, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

June 1, 2021

Last Update Submit

February 23, 2022

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

  • Fear of COVID-19

    Fear of COVID-19 will be evaluated using The Fear of COVID-19 scale. The scale consists of seven items, each with a five-point Likert scale of options. The participant is instructed to choose an option that best represents their perception about the statement presented. Higher score indicates higher levels of fear.

    Change from baseline at 2nd, 3rd and 4th week

Secondary Outcomes (3)

  • Anxiety

    Change from baseline at 2nd, 3rd and 4th week

  • Sleep quality

    Change from baseline at 4th week

  • Health-related quality of life

    Change from baseline at 2nd, 3rd and 4th week

Study Arms (2)

Breathing Exercises group

EXPERIMENTAL

Breathing exercises will be applied via teleconference by a physiotherapist 1 day a week. Individuals will perform exercises by themselves at their homes on the remaining 6 days of the week. Exercise program will be applied for 4 weeks. Individuals will also be informed about COVID-19 for once at baseline.

Other: Breathing ExercisesOther: Information on COVID-19

Control group

OTHER

Individuals will be informed about COVID-19 for once at baseline.

Other: Information on COVID-19

Interventions

Breathing ExercisesOTHER

Breathing exercises including diaphragmatic breathing, thoracic expansion and breathing control exercises

Breathing Exercises group
Information on COVID-19OTHER

Information about COVID-19 based on the advices in "COVID-19 advice for the public" section of World Health Organization website.

Breathing Exercises groupControl group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • volunteering to participate in the study
  • having a smart phone that can be used for teleconferencing purposes

You may not qualify if:

  • have had COVID-19
  • hospital admission for suspected COVID-19 in the past week
  • having acute respiratory tract infection
  • having any diagnosed chronic respiratory, cardiovascular, metabolic or neurological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuh Naci Yazgan University, Department of Physiotherapy and Rehabilitation

Kayseri, Turkey (Türkiye)

Location

Related Publications (1)

  • Kepenek-Varol B, Zeren M, Dincer R, Erkaya S. Breathing and Relaxation Exercises Help Improving Fear of COVID-19, Anxiety, and Sleep Quality: A Randomized Controlled Trial. J Integr Complement Med. 2022 Jul;28(7):579-586. doi: 10.1089/jicm.2021.0381. Epub 2022 Apr 25.

    PMID: 35467962DERIVED

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr.

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 2, 2021

Study Start

June 10, 2021

Primary Completion

September 14, 2021

Study Completion

September 14, 2021

Last Updated

March 9, 2022

Record last verified: 2022-02

Locations

TU(1)