NCT07248579

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

14 days

First QC Date

November 18, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

Pregnancy-Specific Anxiety Tool (PSAT)PSAT-TRPregnancy anxietyAntenatal anxietyPerinatal mental healthScale validationPsychometric analysisReliability and validityTurkish adaptationCross-sectional study

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (1)

  • Determination of optimal PSAT-TR cut-off values for pregnancy-related anxiety

    Within 1 month after primary data analysis

Study Arms (1)

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

Interventions

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.

Also known as: PSAT-TR; STAI-State; PRAQ-R2
Pregnant Women

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

September 17, 2025

Primary Completion

October 1, 2025

Study Completion

October 7, 2025

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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

Locations