EarthquakeNCT06388876
The Effect of Exercise on Post-traumatic Stress Disorder and Sleep Quality in Individuals Affected by the 2023 Kahramanmaraş Earthquakes
A study testing Exercise and lifestyle advice in people with Earthquake and Stress Disorders, Post-Traumatic, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Earthquake, Stress Disorders, Post-Traumatic
- What is being tested?
- Exercise and lifestyle advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-30
- being directly affected by the earthquake in Mardin
- providing voluntary consent to participating in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Earthquake, Stress Disorders, Post-Traumatic
- Being tested
- Exercise, lifestyle advice
- Keywords
- natural disaster, earthquake, exercise, post-traumatic stress disorder, sleep quality, physiotherapy and rehabilitation
- Medical subject headings
- Stress Disorders, Post-Traumatic, Motor Activity, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called lifestyle advice
Members of the exercise group received an exercise intervention twice a week for six weeks accompanied by a physiotherapist.
lifestyle adviceOther
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.).
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise group did aerobic exercise during 6 weeks. Also this group took advice including lifestyle. Receives: Other: Exercise; Other: lifestyle advice |
| control | Experimental | Control group only took advice including lifestyle. Receives: Other: lifestyle advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Apr 2023
- Primary completion15 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EarthquakeStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- there are 2 groups; exercise and control
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Bahar Anaforoglu, Ankara Yildirim Beyazıt University
- Investigators
- bahar külünkoğlu, assoc. prof., Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388876
- Sponsor's protocol ID
- AnkaraYBUbk
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06388876
- Acronym / sponsor ID
- AnkaraYBUbk
- Conditions
- Earthquake, Stress Disorders, Post-Traumatic
- Keywords
- natural disaster, earthquake, exercise, post-traumatic stress disorder, sleep quality, physiotherapy and rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- there are 2 groups; exercise and control
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Exercise, Other: lifestyle adviceExercise group did aerobic exercise during 6 weeks. Also this group took advice including lifestyle. |
| control | Experimental | Other: lifestyle adviceControl group only took advice including lifestyle. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18-30
- being directly affected by the earthquake in Mardin
- providing voluntary consent to participating in the study
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: lifestyle adviceMembers of the exercise group received an exercise intervention twice a week for six weeks accompanied by a physiotherapist. | Other | Exercise |
| lifestyle adviceAt 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.). | Other | Exercise, control |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
bahar külünkoğlu, assoc. prof. principal investigator
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and lifestyle advice in people with Earthquake and Stress Disorders, Post-Traumatic, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic Stress Disorder Short Scale (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.