EarthquakeNCT07058766
Development of Post-Disaster Care Protocol for Pregnant Women and Evaluation of Its Effectiveness
A study testing positively affects the physical and psychological health of pregnant women in the disaster area. in people with Earthquake and Pregnant Women, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
It was designed as a randomized controlled experimental study to determine whether the care protocol planned for pregnant women in the disaster area positively affects their physical and psychological health. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Earthquake, Pregnant Women, Support
- What is being tested?
- positively affects the physical and psychological health of pregnant women in the disaster area.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2025to 15 Mar 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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Over the age of 18,
- Positive (+) pregnancy,
- Able to read and write Turkish and speak and understand Turkish,
- No mental or psychological disorder that would cause difficulty in expressing oneself,
- Not receiving a score between 20-27 (severe depression) on HSA-9,
- No chronic disease or high-risk pregnancy diagnosis requiring hospitalization and follow-up,
- Volunteer to participate in the study
Who cannot join
- Under 18 years of age,
- Foreign nationals who cannot read or write Turkish and are inadequate in speaking or understanding Turkish,
- Those with any mental or psychological disorder/diagnosis,
- Those who score between 20-27 (severe depression) on HSA-9,
- Those with a chronic disease or a diagnosis of high-risk pregnancy requiring hospitalization and follow-up,
- Those who do not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Post-Disaster Care Protocol for Pregnant Women and Evaluation of Its Effectiveness: Hatay, Narlıca Sample
It was designed as a randomized controlled experimental study to determine whether the care protocol planned for pregnant women in the disaster area positively affects their physical and psychological health.
Read the detailed description
The results of this study suggest that spousal and family support has a positive impact on psychosocial health during pregnancy for women who become pregnant after an earthquake. It was determined that participants had difficulties in accessing health services and exhibited symptoms of fear, sleep disorders, depression and trauma. However, pregnancy, even if unplanned, was considered a hope for a new beginning for many women after a devastating earthquake. The study also emphasizes the importance of pregnant women's need for spiritual care, support and especially attention during this process. In summary, comprehensive mental health support will play a critical role in improving the well-being of earthquake-affected pregnant women.
- Conditions
- Earthquake, Pregnant Women, Support
- Being tested
- positively affects the physical and psychological health of pregnant women in the disaster area.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positively affects the physical and psychological health of pregnant women in the disaster area.Behavioural
As time passes after the earthquake, psychological first aid services are not sufficient. Developing a care protocol to provide physical and psychosocial support to pregnant women who are earthquake victims, especially those in the vulnerable group, during the post-disaster disappointment period (months 2-36), is an important unique value of this project.
| Study group | Role | What they receive |
|---|---|---|
| First stage a qualitative and quantitative (parallel design) research was planned | Experimental | In the second stage, Stevens' Star Model: Transformation of Information model will be used while developing the draft Care Protocol.. Necessary permissions have been obtained from Stevens for the use of this model.
For the applicability and comprehensibility of the care protocol, which was developed as a draft after expert opinions, a pre-application/pilot application will be made with 5-7 pregnant women and the final version will be given. At the end of this stage, a Post-Disaster Care Training Manual for Pregnant Women will be developed. In the third stage, a randomized controlled experimental study will be conducted to determine whether the care protocol to be developed positively affects the physical and psychological health of pregnant women in the disaster area. In line with this goal, 43 pregnant women will be included in the intervention group and 43 pregnant women will be included in the control group. Receives: Behavioral: positively affects the physical and psychological health of pregnant women in the disaster area. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining patient health level
PATIENT HEALTH QUESTIONNAIRE - 9 (PHQ-9))
Measured: The first data will be collected up to the 16th week of pregnancy, the second data between the 36th and 38th weeks, and the last data between the 4th and 8th weeks postpartum.
Determining the level of psychosocial health during pregnancy
PSYCHOSOCIAL HEALTH ASSESSMENT SCALE IN PREGNANCY
Measured: The first data will be collected up to the 16th week of pregnancy, the second data between the 36th and 38th weeks.
Determining the level of trauma after an earthquake
POST-EARTHQUAKE TRAUMA LEVEL DETERMINATION SCALE (PSTDBÖ) POST-EARTHQUAKE TRAUMA LEVEL DETERMINATION SCALE (PSTDBÖ)
Measured: The first data will be collected up to the 16th week of pregnancy, the second data between the 36th and 38th weeks, and the last data between the 4th and 8th weeks postpartum.
Determining the level of postpartum depression
EDINBURG POSTPARTUM DEPRESSION SCALE
Measured: The data will be collected between the 4th and 8th weeks postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start9 Mar 2025
- Primary completion15 Nov 2025
- Study completion15 Mar 2026
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 Sakarya 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- . With this research, the physical and psychosocial needs of pregnant women in the disaster area will be determined. In the second stage, Stevens' Star Model: Transformation of Information model will be used while developing the draft Care Protocol.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hatice Tambağ, Prof.Dr., Study director, Hatay Mustafa Kemal Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058766
- Sponsor's protocol ID
- E-16214662-050.01.04-284395-97
- Status last verified
- Jul 2026
- First submitted
- 10 Mar 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Post-Disaster Care Protocol for Pregnant Women and Evaluation of Its Effectiveness: Hatay, Narlıca Sample
- ClinicalTrials.gov ID
- NCT07058766
- Acronym / sponsor ID
- E-16214662-050.01.04-284395-97
- Conditions
- Earthquake, Pregnant Women, Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 9 Mar 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 10 Jul 2025 (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.
It was designed as a randomized controlled experimental study to determine whether the care protocol planned for pregnant women in the disaster area positively affects their physical and psychological health.
Detailed description
The results of this study suggest that spousal and family support has a positive impact on psychosocial health during pregnancy for women who become pregnant after an earthquake. It was determined that participants had difficulties in accessing health services and exhibited symptoms of fear, sleep disorders, depression and trauma. However, pregnancy, even if unplanned, was considered a hope for a new beginning for many women after a devastating earthquake. The study also emphasizes the importance of pregnant women's need for spiritual care, support and especially attention during this process. In summary, comprehensive mental health support will play a critical role in improving the well-being of earthquake-affected pregnant women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- . With this research, the physical and psychosocial needs of pregnant women in the disaster area will be determined. In the second stage, Stevens' Star Model: Transformation of Information model will be used while developing the draft Care Protocol.
| Arm | Type | Receives |
|---|---|---|
| First stage a qualitative and quantitative (parallel design) research was planned | Experimental | Behavioral: positively affects the physical and psychological health of pregnant women in the disaster area.In the second stage, Stevens' Star Model: Transformation of Information model will be used while developing the draft Care Protocol.. Necessary permissions have been obtained from Stevens for the use of this model. For the applicability and comprehensibility of the care protocol, which was developed as a draft after expert opinions, a pre-application/pilot application will be made with 5-7 pregnant women and the final version will be given. At the end of this stage, a Post-Disaster Care Training Manual for Pregnant Women will be developed. In the third stage, a randomized controlled experimental study will be conducted to determine whether the care protocol to be developed positively affects the physical and psychological health of pregnant women in the disaster area. In line with this goal, 43 pregnant women will be included in the intervention group and 43 pregnant women will be included in the control group. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Over the age of 18,
- Positive (+) pregnancy,
- Able to read and write Turkish and speak and understand Turkish,
- No mental or psychological disorder that would cause difficulty in expressing oneself,
- Not receiving a score between 20-27 (severe depression) on HSA-9,
Key exclusion criteria (6 listed)
- Under 18 years of age,
- Foreign nationals who cannot read or write Turkish and are inadequate in speaking or understanding Turkish,
- Those with any mental or psychological disorder/diagnosis,
- Those who score between 20-27 (severe depression) on HSA-9,
- Those with a chronic disease or a diagnosis of high-risk pregnancy requiring hospitalization and follow-up,
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 |
|---|---|---|
| positively affects the physical and psychological health of pregnant women in the disaster area.As time passes after the earthquake, psychological first aid services are not sufficient. Developing a care protocol to provide physical and psychosocial support to pregnant women who are earthquake victims, especially those in the vulnerable group, during the post-disaster disappointment period (months 2-36), is an important unique value of this project. | Behavioural | First stage a qualitative and quantitative (parallel design) research was planned |
Primary outcome
Determining patient health level
Time frame: The first data will be collected up to the 16th week of pregnancy, the second data between the 36th and 38th weeks, and the last data between the 4th and 8th weeks postpartum.
PATIENT HEALTH QUESTIONNAIRE - 9 (PHQ-9))
Determining the level of psychosocial health during pregnancy
Time frame: The first data will be collected up to the 16th week of pregnancy, the second data between the 36th and 38th weeks.
PSYCHOSOCIAL HEALTH ASSESSMENT SCALE IN PREGNANCY
Determining the level of trauma after an earthquake
Time frame: The first data will be collected up to the 16th week of pregnancy, the second data between the 36th and 38th weeks, and the last data between the 4th and 8th weeks postpartum.
POST-EARTHQUAKE TRAUMA LEVEL DETERMINATION SCALE (PSTDBÖ) POST-EARTHQUAKE TRAUMA LEVEL DETERMINATION SCALE (PSTDBÖ)
Determining the level of postpartum depression
Time frame: The data will be collected between the 4th and 8th weeks postpartum.
EDINBURG POSTPARTUM DEPRESSION SCALE
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 28 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Earthquake
Active, not recruitingObservational study
The Perspectives of Those Who Experienced the Kahramanmaraş Earthquake
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Home Visit Simulation-based Earthquake Preparedness Training for Nursing Students
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Effects of the Integrated Grief Therapy on Psychological Resilience, Post-Traumatic Growth, Traumatic Stress, and Grief Processes in Earthquake Survivors
Post-traumatic Stress Disorder (PTSD), Grief (Traumatic Grief and Existential Grief)
Not yet recruiting
Mind-Body Intervention in Earthquake Survivors: 6 mo RCT
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Creative Drama on Gender Role Stress, Attitudes Toward Violence Against Women, and Aggression
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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.
Hatice Tambağ, Prof.Dr. study director
Hatay Mustafa Kemal Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positively affects the physical and psychological health of pregnant women in the disaster area. in people with Earthquake and Pregnant Women, run by Sakarya 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 7 inclusion and 6 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 28 Jul 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?
Determining patient health level (time frame: The first data will be collected up to the 16th week of pregnancy, the second data between the 36th and 38th weeks, and the last data between the 4th and 8th weeks postpartum.). The study lists 4 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 28 Jul 2026.