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

S

Sakarya University

Status

Enrolling

Conditions

Earthquake
Pregnant Women
Support

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07058766
E-16214662-050.01.04-284395-97

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 estimated patients

Sex

Female

Ages

19 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

43 participants in 1 patient group

First stage a qualitative and quantitative (parallel design) research was planned
Experimental group
Description:
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.
Treatment:
Behavioral: positively affects the physical and psychological health of pregnant women in the disaster area.

Trial contacts and locations

1

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Central trial contact

Hatice Tambağ, Prof. Dr.; Döndü SEVİMLİ GÜLER, Dr. Lecturer

Data sourced from clinicaltrials.gov

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