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

NCT ID: NCT07248579

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-17

Study Completion Date

2025-10-07

Brief Summary

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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

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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.

Conditions

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Pregnancy-related Anxiety Antenatal Anxiety Perinatal Mental Health

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Survey Administration

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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PSAT-TR; STAI-State; PRAQ-R2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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İstanbul Gaziosmanpaşa Training and Research Hospital

UNKNOWN

Sponsor Role collaborator

Havva Betül Bacak

OTHER_GOV

Sponsor Role lead

Responsible Party

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Havva Betül Bacak

M.D

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Bayrampour H, Hohn RE, Tamana SK, Sawatzky R, Janssen PA, Bone JN, Fairbrother N, Joseph KS. Pregnancy-Specific Anxiety Tool (PSAT): Instrument Development and Psychometric Evaluation. J Clin Psychiatry. 2023 Apr 19;84(3):22m14696. doi: 10.4088/JCP.22m14696.

Reference Type RESULT
PMID: 37074299 (View on PubMed)

Other Identifiers

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psat turkish validation

Identifier Type: -

Identifier Source: org_study_id

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