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Clinical Trials/NCT07248579
NCT07248579CompletedNot Applicable

Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of the Pregnancy-Specific Anxiety Tool (PSAT-TR) Among Pregnant Women

Havva Betül Bacak1 site in 1 country300 target enrollmentStarted: September 17, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
300
Locations
1
Primary Endpoint
Psychometric validity and reliability of the Turkish version of the Pregnancy-Specific Anxiety Tool (PSAT-TR)

Study Overview

Brief Summary

The Pregnancy-Specific Anxiety Tool (PSAT) is a newly developed instrument designed to assess anxiety specific to pregnancy across multiple domains. This methodological, cross-sectional study aims to adapt the PSAT into Turkish and to evaluate its psychometric properties among pregnant women in Turkey. The study evaluates the reliability and validity of the Turkish version (PSAT-TR) through internal consistency, factor analysis, and criterion validity analyses using the State-Trait Anxiety Inventory-State (STAI-State) and the Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2). Data were collected from pregnant women attending antenatal care at Gaziosmanpasa Training and Research Hospital. The study hypothesizes that the Turkish version of PSAT is a valid and reliable instrument to assess pregnancy-related anxiety in the Turkish population.

Detailed Description

This methodological, cross-sectional, single-center study was conducted to adapt the Pregnancy-Specific Anxiety Tool (PSAT) into Turkish and to evaluate its psychometric properties. The PSAT is a 33-item scale developed by Harrison et al. (2023) to assess pregnancy-specific anxiety across six domains: (1) severity of anxiety, (2) health and well-being of the baby, (3) labor and maternal well-being, (4) postpartum concerns, (5) career and financial issues, and (6) social support.

The adaptation process followed internationally accepted guidelines, including forward and backward translation, expert committee review, and pilot testing to ensure linguistic and cultural equivalence. The final Turkish version (PSAT-TR) was administered to pregnant women aged 18 years and older, between 12 and 40 weeks of gestation, who attended routine antenatal follow-up at Gaziosmanpasa Training and Research Hospital. Participants provided written informed consent, and the study was approved by the hospital's Non-Interventional Clinical Research Ethics Committee (Approval No: 2025/-, Date: September 17, 2025).

Data were collected between September and October 2025. A total of approximately 300 participants completed the PSAT-TR, STAI-State, and PRAQ-R2 questionnaires. Internal consistency reliability was assessed using Cronbach's alpha coefficients. Construct validity was evaluated through exploratory and confirmatory factor analyses. Criterion validity was examined via correlations between PSAT-TR, STAI-State, and PRAQ-R2 scores. Receiver Operating Characteristic (ROC) analysis was used to determine optimal PSAT cut-off values based on STAI-State (≥40) and PRAQ-R2 (≥30) reference points.

The study aims to provide a culturally adapted, valid, and reliable tool to measure pregnancy-specific anxiety in Turkish-speaking populations. This tool may facilitate early identification of anxiety symptoms and inform preventive strategies in perinatal mental health care.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Pregnant women aged 18-45 years
  • Currently in 12-40 weeks of gestation
  • Able to read and understand Turkish
  • Voluntarily agreed to participate and provided written informed consent
  • Attending routine antenatal care at Gaziosmanpasa Training and Research Hospital

Exclusion Criteria

  • Presence of a diagnosed psychiatric disorder
  • Current use of psychiatric medication
  • High-risk pregnancy or severe obstetric complication
  • Inability to complete self-report questionnaires due to cognitive or literacy limitations

Outcomes

Primary Outcomes

Psychometric validity and reliability of the Turkish version of the Pregnancy-Specific Anxiety Tool (PSAT-TR)

Time Frame: Within 1 month after data collection

The primary outcome is to assess the psychometric properties of the Turkish version of the Pregnancy-Specific Anxiety Tool (PSAT-TR) through exploratory and confirmatory factor analysis, internal consistency (Cronbach's alpha), and test-retest reliability. Validity is examined by comparing PSAT-TR scores with the State-Trait Anxiety Inventory-State (STAI-State) and the Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2).

Secondary Outcomes

  • Determination of optimal PSAT-TR cut-off values for pregnancy-related anxiety(Within 1 month after primary data analysis)

Investigators

Sponsor
Havva Betül Bacak
Sponsor Class
Other Gov
Responsible Party
Sponsor Investigator
Principal Investigator

Havva Betül Bacak

M.D

Gaziosmanpasa Research and Education Hospital

Study Sites (1)

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