跳至主要内容
临床试验/NCT07842575
NCT07842575招募中不适用

Development of the Kinesiophobia Severity Scale in Urinary Incontinence: A Validity and Reliability Study

Ahi Evran University Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Content Validity of the Kinesiophobia Severity Scale in Urinary Incontinence (KSS-UI)

研究概览

简要总结

This study aims to develop and validate a novel Turkish-language self-report instrument, the Kinesiophobia Severity Scale in Urinary Incontinence (KSS-UI), to assess movement avoidance and fear of movement associated with concerns about urinary leakage in individuals with urinary incontinence. Following scale development, its validity and reliability will be evaluated through psychometric analyses in accordance with the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) recommendations.

详细描述

This methodological study aims to develop and evaluate the validity and reliability of the Kinesiophobia Severity Scale in Urinary Incontinence (KSS-UI), a novel Turkish-language self-report instrument designed to assess fear of movement and movement avoidance associated with concerns about urinary leakage.

The study will include individuals with urinary incontinence, including stress, urgency, and mixed urinary incontinence. Participants will be recruited exclusively from individuals reporting urinary incontinence among relatives of patients attending the Physical Therapy and Rehabilitation Center. Individuals who meet the eligibility criteria and voluntarily agree to participate will be enrolled in the study. Written informed consent will be obtained from all participants before data collection.

Initially, an item pool was developed through a comprehensive literature review, semi-structured interviews with 15-20 individuals with urinary incontinence, and recommendations from experts in relevant clinical disciplines. Following ethical approval, the items will undergo content validity assessment by a multidisciplinary panel of at least 10 experts. Item relevance, clarity, simplicity, and necessity will be evaluated using the Content Validity Ratio (CVR), Content Validity Index (CVI), and modified kappa statistics.

Subsequently, face validity and comprehensibility will be assessed through cognitive interviews with 8-12 individuals. Items will be revised based on participant feedback. Pilot testing will be conducted to examine item distributions, floor and ceiling effects, corrected item-total correlations, internal consistency, and item discrimination.

Following these preliminary evaluations, the revised scale will be administered to eligible participants during a single assessment session. Questionnaire completion is expected to take approximately 15-20 minutes.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Being 18 years of age or older
  • •Reporting symptoms of incontinence at least once a week for the past 3 months (ICIQ-SF score ≥ 1)
  • •Having the ability to read and comprehend Turkish
  • •Having been informed about the study and provided written informed consent

排除标准

  • •Having an active lower urinary tract infection
  • •Inability to complete the scales independently due to cognitive impairment, advanced dementia, or limited literacy
  • •Individuals who refuse to participate in the study or do not sign the informed consent form

研究组 & 干预措施

Incontinance

This group will consist of individuals with urinary incontinence, including stress, urgency, and mixed urinary incontinence, who are recruited from among relatives of patients attending the Physical Therapy and Rehabilitation Center. Eligible participants who voluntarily agree to participate will complete the newly developed Kinesiophobia Severity Scale in Urinary Incontinence (KSS-UI) to assess fear of movement and movement avoidance associated with concerns about urinary leakage. The scale will undergo psychometric evaluation to assess its validity and reliability. No therapeutic intervention will be administered as part of the study.

结局指标

主要结局

Content Validity of the Kinesiophobia Severity Scale in Urinary Incontinence (KSS-UI)

时间窗: During the initial expert evaluation, before participant recruitment for the main validation study.

The content validity of the newly developed scale will be evaluated by a multidisciplinary panel of at least 10 experts. Item relevance, clarity, simplicity, and necessity will be assessed using the Content Validity Ratio (CVR), Item-level Content Validity Index (I-CVI), Scale-level Content Validity Index (S-CVI), and modified kappa statistics.

次要结局

  • Internal Consistency of the KSS-UI(Baseline (single assessment session; approximately 15-20 minutes).)
  • Item Discrimination and Item Performance of the KSS-UI(Baseline (single assessment session; approximately 15-20 minutes).)

研究者

发起方
Ahi Evran University Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra BAYRAMOĞLU DEMİRDÖĞEN

Lecturer

Ahi Evran University Education and Research Hospital

研究点 (1)

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