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

NCT07058766 | Recruiting

• 1 other identifier: E-16214662-050.01.04-284395-97
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Earthquake; Pregnant Women; Support

Outcome Measures

Primary Outcomes (4)

• Determining patient health level

  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

  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

  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

  EDINBURG POSTPARTUM DEPRESSION SCALE

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

Study Arms (1)

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.

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

Interventions

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.

First stage a qualitative and quantitative (parallel design) research was planned

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Hatay Mustafa Kemal Üniversitesi

Hatay, Turkey (Türkiye)

RECRUITING

Study Officials

• Hatice Tambağ, Prof.Dr.

  Hatay Mustafa Kemal Üniversitesi

  STUDY DIRECTOR

Central Study Contacts

Döndü SEVİMLİ GÜLER, Dr. Lecturer

CONTACT

+905057736638; donduguler@subu.edu.tr

Hatice Tambağ, Prof. Dr.

CONTACT

05326529462; htambag@mku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: . 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.

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: July 10, 2025
• Study Start: March 9, 2025
• Primary Completion: November 15, 2025
• Study Completion: March 15, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)