- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06388876
The Effect of Exercise on Post-traumatic Stress Disorder and Sleep Quality in Individuals Affected by the 2023 Kahramanmaraş Earthquakes
April 24, 2024 updated by: Bahar Anaforoglu, Ankara Yildirim Beyazıt University
The Effect of Exercise Interventions on Post-traumatic Stress Disorder and Sleep Quality in Young Individuals Directly Affected by the 2023 Kahramanmaraş Earthquakes in Türkiye: A Randomized Controlled Double-Blind Study
Natural disasters can have adverse impacts on both physical and mental health.
Post-traumatic stress disorder (PTSD) and sleep disorders are among the most common problems seen after natural disasters.
Exercise may represent a safe, cost-effective, accessible, non-pharmacological method for treating PTSD and sleep problems.
The aim of this study was to investigate the effect of exercise interventions on PTSD and sleep quality in young individuals affected by the 2023 Kahramanmaraş earthquakes in Türkiye.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
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
-
-
-
Ankara, Turkey
- Ankara Yildirim Beyazıt University
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- age 18-30
- being directly affected by the earthquake in Mardin
- providing voluntary consent to participating in the study
Exclusion Criteria:
- involvement in an existing active regular exercise program
- the presence a physical problem capable of preventing exercise
- the presence of severe psychiatric disorders or cognitive and/or perceptual problems
- regular use of sedative or neuropsychiatric drugs
- active alcohol or drug addiction
- missing assessment parameters
- failure to participate in the intervention programs, or not continuing wıth the study
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise
Exercise group did aerobic exercise during 6 weeks.
Also this group took advice including lifestyle.
|
Members of the exercise group received an exercise intervention twice a week for six weeks accompanied by a physiotherapist.
Other Names:
At the beginning of the program, the members of the individuals were given lifestyle recommendations, both verbally and in writing (in the form of a brochure) within the scope of a common training initiative.The individuals groups received both written (brochure) and verbal training within the scope of lifestyle recommendations (the effects of planned and regular exercise, sleep problems, methods of coping with stress, etc.).
|
|
Experimental: control
Control group only took advice including lifestyle.
|
At the beginning of the program, the members of the individuals were given lifestyle recommendations, both verbally and in writing (in the form of a brochure) within the scope of a common training initiative.The individuals groups received both written (brochure) and verbal training within the scope of lifestyle recommendations (the effects of planned and regular exercise, sleep problems, methods of coping with stress, etc.).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-traumatic Stress Disorder Short Scale
Time Frame: 6 weeks
|
This self-report Likert-type scale was developed by LeBeau et al. in order to assess post-traumatic stress symptoms.
The scale consists of nine questions and a single dimension.
Each question is scored between 0 for "Not at all" and 4 for "Extremely".
Total possible scores range between 0 and 36.
The higher the total score, the higher the level of Post-traumatic Stress Disorder .
The cut-off value of the scale was calculated as 24
|
6 weeks
|
|
Pittsburgh Sleep Quality Index
Time Frame: 6 weeks
|
The Pittsburgh Sleep Quality Index consists of 24 questions and seven categories that yield information about the type and severity of sleep disturbance experienced in the past month.
The Pittsburgh Sleep Quality Index includes questions assessing sleep quality, transition time, duration, efficiency, disturbance, sleep medication use, and daytime dysfunction due to sleep problems.
Each item is scored from 0 (no distress at all) to 3 (severe distress).
Total possible scores range from 0 to 21.
A higher score means poorer sleep quality.
A total score of 0-5 is regarded as indicating healthy sleep, 6-10 as poor sleep, and above 10 as long-term sleep disturbance.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: bahar külünkoğlu, assoc. prof., Ankara Yildirim Beyazıt University
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 1, 2023
Primary Completion (Actual)
June 15, 2023
Study Completion (Actual)
July 30, 2023
Study Registration Dates
First Submitted
April 22, 2024
First Submitted That Met QC Criteria
April 24, 2024
First Posted (Actual)
April 29, 2024
Study Record Updates
Last Update Posted (Actual)
April 29, 2024
Last Update Submitted That Met QC Criteria
April 24, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AnkaraYBUbk
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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