Turkish Validation of the Pregnancy-Specific Anxiety Tool (PSAT) (PSAT-TR)

November 18, 2025 updated by: Havva Betül Bacak

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

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

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

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

Sampling Method

Non-Probability Sample

Study Population

The study population consisted of pregnant women aged 18-45 years who attended routine antenatal follow-up at Gaziosmanpasa Training and Research Hospital. Participants were healthy, low-risk pregnancies without any known psychiatric or obstetric complications.

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant Women
Pregnant women aged 18 years and older who attended routine antenatal care at Gaziosmanpasa Training and Research Hospital between September and October 2025. Participants completed three self-report questionnaires: the Turkish version of the Pregnancy-Specific Anxiety Tool (PSAT-TR), the State-Trait Anxiety Inventory-State (STAI-State), and the Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2). No medical, pharmacological, or procedural intervention was applied.
Other: Survey Administration
Administration of three self-report questionnaires for psychometric validation: the Turkish version of the Pregnancy-Specific Anxiety Tool (PSAT-TR), the State-Trait Anxiety Inventory-State (STAI-State), and the Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2). Participants completed the questionnaires during a single antenatal clinic visit. No medical, pharmacological, or procedural intervention was applied.
Other Names:
  • PSAT-TR; STAI-State; PRAQ-R2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Within 1 month after data collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of optimal PSAT-TR cut-off values for pregnancy-related anxiety
Time Frame: Within 1 month after primary data analysis
The secondary outcome is to determine optimal cut-off scores of the PSAT-TR for detecting elevated pregnancy-related anxiety. Receiver Operating Characteristic (ROC) analysis will be performed using STAI-State (≥40) and PRAQ-R2 (≥30) as external reference standards to evaluate sensitivity, specificity, and area under the curve (AUC) values.
Within 1 month after primary data analysis

Collaborators and Investigators

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

Sponsor

Havva Betül Bacak

Collaborators

İstanbul Gaziosmanpaşa Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 17, 2025

Primary Completion (Actual)

October 1, 2025

Study Completion (Actual)

October 7, 2025

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • psat turkish validation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant-level data are not intended for public sharing due to ethical and institutional restrictions.

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.

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