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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06388876
Other study ID # AnkaraYBUbk
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date July 30, 2023

Study information

Verified date April 2024
Source Ankara Yildirim Beyazit University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date July 30, 2023
Est. primary completion date June 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 with the study

Study Design


Intervention

Other:
Exercise
Members of the exercise group received an exercise intervention twice a week for six weeks accompanied by a physiotherapist.
lifestyle advice
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.).

Locations

Country Name City State
Turkey Ankara Yildirim Beyazit University Ankara

Sponsors (2)

Lead Sponsor Collaborator
Ankara Yildirim Beyazit University TÜBITAK

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-traumatic Stress Disorder Short Scale 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
Primary Pittsburgh Sleep Quality Index 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
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