NCT06013280

Brief Summary

The aim of this study is to investigate the effect of relaxation and breathing exercises on individuals experiencing post-earthquake stress-related symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

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

Study Start

First participant enrolled

March 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 22, 2023

Last Update Submit

August 25, 2023

Conditions

EarthquakeMental Health Issue

Keywords

earthquakephysiotherapybreathing exerciserelaxing exercisestressmental health

Outcome Measures

Primary Outcomes (1)

  • Beck Anxiety (BAI)

    Beck Anxiety Inventory is a brief measure of anxiety with a focus on somatic symptoms of anxiety that was developed as a measure adept at discriminating between anxiety and depression. It is a self-report scale consisting of 21 items. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The total score ranges from 0-63. The following guidelines are recommended for the interpretation of scores: 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety.

    four weeks

Secondary Outcomes (5)

  • The Posttraumatic Stress Diagnostic Scale (PDS)

    four weeks

  • Beck Depression Inventory (BDI)

    four weeks

  • Perceived Stress Scale -10

    four weeks

  • Pittsburgh Sleep Quality Index

    four weeks

  • SF-12

    four weeks

Study Arms (2)

Relaxing Exercise Group

EXPERIMENTAL

Relaxing exercise group participants applied 40 minutes of progressive muscle relaxation and breathing exercises, 3 times a week for 4 weeks

Other: Progresive Muscle Relaxation and Breathing Exercise

Control Group

NO INTERVENTION

This group received no intervention, continued their daily life as usual.

Interventions

Progresive Muscle Relaxation and Breathing ExerciseOTHER

Intervention protocol contains 40 minuntes sessions, which involved tensing and relaxing the body along with deep breathing. Protocol consisted with; Warm-up (5 minutes breathing exercise) Progressive Muscle Relaxation Exercises (The participants performed PMR for each body part in a particular order, beginning with the face muscles and head, followed by neck, shoulders, chest, abdomen, legs, and feet. This muscle tensing and relaxing procedures were performed in accompaniment with deep breathing.) Cool-down (5 minutes breathing exercise)

Relaxing Exercise Group

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals with a Beck anxiety inventory score greater than 8 and anxiety experience for more than 1 month
  • Individuals who experienced the earthquake of February 6, 2023 Kahramanmaraş / Türkiye and agreed to participate in the study
  • Individuals without cognitive impairment
  • Individuals who can understand and apply verbal commands in Turkish

You may not qualify if:

  • Any history of psychiatric medication support for the last 6 months
  • Any history of psychological problems before the earthquake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34820, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Sabiha Irem Sancaktar, M.Sc.

    Istanbul Medipol Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups with a control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 22, 2023

First Posted

August 28, 2023

Study Start

March 20, 2023

Primary Completion

June 25, 2023

Study Completion

June 25, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Locations

TU(1)