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Completed

NCT Number: NCT07058766

Development of Post-Disaster Care Protocol for Pregnant Women and Evaluation of Its Effectiveness

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.

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Key information

Conditions

Earthquake Pregnant Women Support

Age range

19 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hatay Mustafa Kemal Üniversitesi

Hatay, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

positively affects the physical and psychological health of pregnant women in the disaster area.

Behavioral

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.

Primary outcomes

  1. 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))

  2. 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

  3. 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)

  4. Determining the level of postpartum depression

    Time frame: The data will be collected between the 4th and 8th weeks postpartum.

    EDINBURG POSTPARTUM DEPRESSION SCALE

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

Development of Post-Disaster Care Protocol for Pregnant Women and Evaluation of Its Effectiveness: Hatay, Narlıca Sample

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 10, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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