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NCT Number: NCT07842575

DEVELOPMENT AND VALIDATION OF THE URINARY INCONTINENCE KINESIOPHOBIA SEVERITY SCALE

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Kırşehir Ahi Evran Üniversitesi

Kırşehir, 40100, Turkey (Türkiye)

Location status: Recruiting

About this study

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.

Psychometric analyses will be performed to evaluate the validity and reliability of the scale. Based on the findings, the final scale will be established, and a scoring and interpretation guide will be developed.

The study is expected to provide a valid and reliable instrument for assessing urinary incontinence-related kinesiophobia and contribute to the evaluation of movement-related fear and avoidance behaviors in individuals with urinary incontinence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Internal Consistency of the KSS-UI

    Time frame: Baseline (single assessment session; approximately 15-20 minutes).

    The internal consistency of the KSS-UI will be evaluated using Cronbach's alpha coefficient and corrected item-total correlations. The contribution of individual items to scale reliability will also be examined.

  2. Item Discrimination and Item Performance of the KSS-UI

    Time frame: Baseline (single assessment session; approximately 15-20 minutes).

    Item performance will be evaluated by examining item distributions, floor and ceiling effects, and corrected item-total correlations. Item discrimination will be assessed by comparing item scores between the upper and lower 27% of participants based on total scale scores.

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Sponsors and collaborators

Lead sponsor

Ahi Evran University Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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