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临床试验/NCT07248579
NCT07248579已完成不适用

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

Havva Betül Bacak1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年9月17日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Psychometric validity and reliability of the Turkish version of the Pregnancy-Specific Anxiety Tool (PSAT-TR)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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).

次要结局

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

研究者

发起方
Havva Betül Bacak
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Havva Betül Bacak

M.D

Gaziosmanpasa Research and Education Hospital

研究点 (1)

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