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

NCT ID: NCT07058766

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-09
• Study Completion Date: 2026-03-15

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hatice Tambağ, Prof.Dr.

Role: STUDY_DIRECTOR

Hatay Mustafa Kemal Üniversitesi

Locations

Hatay Mustafa Kemal Üniversitesi

Hatay, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Döndü SEVİMLİ GÜLER, Dr. Lecturer

Role: CONTACT

donduguler@subu.edu.tr

+905057736638

Hatice Tambağ, Prof. Dr.

Role: CONTACT

htambag@mku.edu.tr

05326529462

Facility Contacts

Hatice Tambağ, Prof.Dr.

Role: primary

htambag@mku.edu.tr

05326529462

Other Identifiers

E-16214662-050.01.04-284395-97

Identifier Type: -

Identifier Source: org_study_id