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

June 30, 2025 updated by: Sakarya University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Hatay, Turkey
        • Recruiting
        • Hatay Mustafa Kemal Üniversitesi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: First stage a qualitative and quantitative (parallel design) research was planned

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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
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
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
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
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)
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
Time Frame: The data will be collected between the 4th and 8th weeks postpartum.
EDINBURG POSTPARTUM DEPRESSION SCALE
The data will be collected between the 4th and 8th weeks postpartum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sakarya University

Investigators

  • Study Director: Hatice Tambağ, Prof.Dr., Hatay Mustafa Kemal Üniversitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2025

Primary Completion (Estimated)

November 15, 2025

Study Completion (Estimated)

March 15, 2026

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

June 30, 2025

First Posted (Actual)

July 10, 2025

Study Record Updates

Last Update Posted (Actual)

July 10, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • E-16214662-050.01.04-284395-97

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnant Women

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe