Post-Traumatic Stress SymptomsNCT07781904
Psychoeducation-Supported Breathing and Relaxation for Earthquake Survivors
A study testing Psychoeducation-Supported Breathing and Relaxation Program in people with Post-Traumatic Stress Symptoms and Poor Sleep Quality, run by Rana Ceviz at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study evaluated whether a structured program combining psychoeducation, breathing exercises, and relaxation techniques could reduce post-traumatic stress symptoms and improve sleep quality among adult earthquake survivors living in temporary accommodation in Malatya, Türkiye. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Symptoms, Poor Sleep Quality
- What is being tested?
- Psychoeducation-Supported Breathing and Relaxation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Oct 2025to 31 Jan 2026
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Experienced the February 6, 2023 earthquakes
- Aged 18 to 65 years
- Able to read and understand Turkish
- Provided written informed consent to participate
Who cannot join
- Incomplete or invalid questionnaires
- Inability to attend the intervention sessions regularly
- Self-reported history of a severe psychiatric diagnosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Malatya Teknokent Temporary Accommodation Center
Malatya, 44330
About this study
Official title: The Effects of Psychoeducation-Supported Breathing and Relaxation Exercises on Post-Traumatic Stress Symptoms and Sleep Quality in Earthquake Survivors
This randomized controlled study evaluated whether a structured program combining psychoeducation, breathing exercises, and relaxation techniques could reduce post-traumatic stress symptoms and improve sleep quality among adult earthquake survivors living in temporary accommodation in Malatya, Türkiye.
A total of 90 participants were randomly assigned in equal numbers to an intervention group or a control group. The intervention group attended six face-to-face group sessions delivered twice weekly over three weeks. The program included education about trauma and stress, diaphragmatic breathing, progressive muscle relaxation, coping strategies, sleep hygiene, cognitive restructuring, positive imagery, and guidance for continued practice. The control group received no structured intervention and continued its usual daily routine.
Post-traumatic stress symptoms and sleep quality were assessed before and after the intervention using the Post-Traumatic Stress Disorder Short Scale and the Pittsburgh Sleep Quality Index. The study compared changes in these outcomes between the intervention and control groups.
- Conditions
- Post-Traumatic Stress Symptoms, Poor Sleep Quality
- Being tested
- Psychoeducation-Supported Breathing and Relaxation Program
- Keywords
- Earthquake Survivors, Psychoeducation, Breathing Exercises, Relaxation Techniques, Diaphragmatic Breathing, Progressive Muscle Relaxation, Post-Traumatic Stress Symptoms, Sleep Quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation-Supported Breathing and Relaxation ProgramBehavioural
Participants attended six face-to-face group sessions delivered twice weekly over three weeks. Each session lasted approximately 60-75 minutes. The program included psychoeducation about trauma and stress responses, diaphragmatic breathing with approximately 4 seconds of inhalation and 6-8 seconds of exhalation, progressive muscle relaxation, adaptive coping strategies, sleep hygiene, cognitive restructuring, positive imagery, and relapse-prevention guidance. Participants were encouraged to practice diaphragmatic breathing for at least 10 minutes daily and to use the relaxation techniques before sleep. Make-up sessions were offered when necessary.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation-Supported Breathing and Relaxation | Experimental | Participants received six face-to-face group sessions over three weeks, with two sessions per week. The program included psychoeducation about trauma and stress, diaphragmatic breathing, progressive muscle relaxation, coping strategies, sleep hygiene, cognitive restructuring, positive imagery, and guidance for continued practice. Receives: Behavioral: Psychoeducation-Supported Breathing and Relaxation Program |
| Control Group | No intervention | Participants received no structured training or study intervention and continued their usual daily routines in the temporary accommodation center during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-Traumatic Stress Symptoms Assessed by the PTSD-SS
Post-traumatic stress symptoms were assessed using the 9-item Post-Traumatic Stress Disorder Short Scale (PTSD-SS). Each item is scored from 0 to 4, producing a total score ranging from 0 to 36. Higher scores indicate more severe post-traumatic stress symptoms. Change from baseline to the post-intervention assessment was evaluated.
Measured: Baseline and immediately after the 3-week intervention
Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of seven component scores and produces a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality, and scores above 5 indicate poor sleep quality. Change from baseline to the post-intervention assessment was evaluated.
Measured: Baseline and immediately after the 3-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start11 Oct 2025
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress SymptomsStudies of the same condition, open and under way.
- 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
- Participants were randomly assigned in a 1:1 ratio to either the intervention group or the control group.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rana Ceviz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rana Ceviz, Malatya Turgut Ozal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781904
- Sponsor's protocol ID
- OZAL-TN-RC-02
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article will be shared. These data may include relevant sociodemographic and earthquake-related characteristics, group assignment, and baseline and post-intervention PTSD-SS and PSQI scores. Direct personal identifiers will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Psychoeducation-Supported Breathing and Relaxation Exercises on Post-Traumatic Stress Symptoms and Sleep Quality in Earthquake Survivors
- ClinicalTrials.gov ID
- NCT07781904
- Acronym / sponsor ID
- OZAL-TN-RC-02
- Conditions
- Post-Traumatic Stress Symptoms, Poor Sleep Quality
- Keywords
- Earthquake Survivors, Psychoeducation, Breathing Exercises, Relaxation Techniques, Diaphragmatic Breathing, Progressive Muscle Relaxation, Post-Traumatic Stress Symptoms, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Rana CevizUniversity, hospital or other
- Study start
- 11 Oct 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 24 Aug 2026 (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.
This randomized controlled study evaluated whether a structured program combining psychoeducation, breathing exercises, and relaxation techniques could reduce post-traumatic stress symptoms and improve sleep quality among adult earthquake survivors living in temporary accommodation in Malatya, Türkiye.
A total of 90 participants were randomly assigned in equal numbers to an intervention group or a control group. The intervention group attended six face-to-face group sessions delivered twice weekly over three weeks. The program included education about trauma and stress, diaphragmatic breathing, progressive muscle relaxation, coping strategies, sleep hygiene, cognitive restructuring, positive imagery, and guidance for continued practice. The control group received no structured intervention and continued its usual daily routine.
Post-traumatic stress symptoms and sleep quality were assessed before and after the intervention using the Post-Traumatic Stress Disorder Short Scale and the Pittsburgh Sleep Quality Index. The study compared changes in these outcomes between the intervention and control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either the intervention group or the control group.
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation-Supported Breathing and Relaxation | Experimental | Behavioral: Psychoeducation-Supported Breathing and Relaxation ProgramParticipants received six face-to-face group sessions over three weeks, with two sessions per week. The program included psychoeducation about trauma and stress, diaphragmatic breathing, progressive muscle relaxation, coping strategies, sleep hygiene, cognitive restructuring, positive imagery, and guidance for continued practice. |
| Control Group | No intervention | –Participants received no structured training or study intervention and continued their usual daily routines in the temporary accommodation center during the study period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Experienced the February 6, 2023 earthquakes
- Aged 18 to 65 years
- Able to read and understand Turkish
- Provided written informed consent to participate
Key exclusion criteria (3 listed)
- Incomplete or invalid questionnaires
- Inability to attend the intervention sessions regularly
- Self-reported history of a severe psychiatric diagnosis
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 |
|---|---|---|
| Psychoeducation-Supported Breathing and Relaxation ProgramParticipants attended six face-to-face group sessions delivered twice weekly over three weeks. Each session lasted approximately 60-75 minutes. The program included psychoeducation about trauma and stress responses, diaphragmatic breathing with approximately 4 seconds of inhalation and 6-8 seconds of exhalation, progressive muscle relaxation, adaptive coping strategies, sleep hygiene, cognitive restructuring, positive imagery, and relapse-prevention guidance. Participants were encouraged to practice diaphragmatic breathing for at least 10 minutes daily and to use the relaxation techniques before sleep. Make-up sessions were offered when necessary. | Behavioural | Psychoeducation-Supported Breathing and Relaxation |
Primary outcome
Change in Post-Traumatic Stress Symptoms Assessed by the PTSD-SS
Time frame: Baseline and immediately after the 3-week intervention
Post-traumatic stress symptoms were assessed using the 9-item Post-Traumatic Stress Disorder Short Scale (PTSD-SS). Each item is scored from 0 to 4, producing a total score ranging from 0 to 36. Higher scores indicate more severe post-traumatic stress symptoms. Change from baseline to the post-intervention assessment was evaluated.
Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index
Time frame: Baseline and immediately after the 3-week intervention
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of seven component scores and produces a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality, and scores above 5 indicate poor sleep quality. Change from baseline to the post-intervention assessment was evaluated.
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 25 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published article will be shared. These data may include relevant sociodemographic and earthquake-related characteristics, group assignment, and baseline and post-intervention PTSD-SS and PSQI scores. Direct personal identifiers will not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation-Supported Breathing and Relaxation Program in people with Post-Traumatic Stress Symptoms and Poor Sleep Quality, run by Rana Ceviz 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 4 inclusion and 3 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 25 Aug 2026. 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?
Change in Post-Traumatic Stress Symptoms Assessed by the PTSD-SS (time frame: Baseline and immediately after the 3-week intervention). 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 25 Aug 2026.