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Completed

NCT Number: NCT07469748

Health Belief Model Scale Development for Disability and Abilities in Vestibular Migraine Patients

Vestibular migraine (VM) is a neurological condition characterized by recurrent episodes of dizziness, imbalance, and migraine-related symptoms. Individuals' responses to health problems are influenced by their health beliefs. The Health Belief Model (HBM) is widely used to evaluate health beliefs, including perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy.

The aim of this study is to develop a Health Belief Model-based scale regarding disability and abilities in patients with vestibular migraine and to evaluate its psychometric properties. During the scale development process, expert opinions from specialists in audiology, psychiatry, neurology, and linguistics will be obtained to assess the content validity of the scale items.

The developed scale will be administered to patients diagnosed with vestibular migraine. In addition, participants in the research group will receive information and awareness training about vestibular migraine in order to increase health belief levels related to disability and abilities. Statistical analyses will be performed to evaluate the psychometric properties of the scale and the applicability of the intervention model.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Aydın University

Istanbul, Kucukcekmece, 34295, Turkey (Türkiye)

About this study

Vestibular migraine (VM) is a neurological condition characterized by recurrent episodes of vertigo, dizziness, imbalance, and migraine-related symptoms. These symptoms may affect daily functioning, participation in social activities, and quality of life. Because vestibular migraine is a chronic and recurrent condition, individuals' health behaviors and coping strategies are considered important in disease management. These behaviors may be influenced by patients' health beliefs.

Health beliefs are commonly conceptualized using the Health Belief Model (HBM), which includes six major constructs: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy. These constructs are used to explain how individuals perceive health risks and how they adopt or maintain health-related behaviors.

The aim of this study is to develop a new measurement scale based on the Health Belief Model for patients with vestibular migraine in the field of Audiology and to evaluate the psychometric properties of the scale. During the scale development process, content validity will be assessed through expert review. A multidisciplinary expert panel consisting of audiology specialists, a psychiatrist, a neurologist, and linguistics specialists will evaluate the item pool in terms of relevance, clarity, and representativeness of the Health Belief Model constructs. Based on expert feedback, the items will be revised and finalized.

The revised scale will be administered to patients diagnosed with vestibular migraine. Psychometric analyses will be conducted to evaluate the factor structure, validity, and reliability of the scale. These analyses will include content validity assessment, factor analysis, and internal consistency evaluation.

Following the scale development phase, an interventional component will be conducted to evaluate the applicability of the developed scale. Patients diagnosed with vestibular migraine will complete the scale at baseline. Subsequently, a single-session educational intervention focusing on vestibular migraine awareness and management will be provided. The intervention will aim to improve patients' health belief levels by addressing the six sub-dimensions of the Health Belief Model: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy.

After the intervention session, the scale will be administered again to assess changes in participants' health belief levels over time. In addition, the relationship between the developed vestibular migraine health belief scale and quality of life will be evaluated using the World Health Organization Quality of Life Scale (WHOQOL-BREF).

Participant flow and study procedures will be reported according to the CONSORT 2010 flow diagram. Statistical analyses will be conducted using SmartPLS 3 and SPSS version 25.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with vestibular migraine
  • Currently undergoing active treatment for vestibular migraine
  • Literate and able to complete questionnaires
  • Willing to participate and able to cooperate with study procedures

Exclusion criteria

  • Presence of hearing loss
  • History of systemic diseases unrelated to vestibular migraine
  • Presence of otologic or neurological pathologies
  • Inability to complete follow-up procedures
  • Lack of cooperation with study procedures
  • Presence of balance disorders other than vestibular migraine
  • Presence of vertigo caused by conditions other than vestibular migraine

Treatment and study plan

Vestibular Migraine Education / Awareness Session

Behavioral

Participants diagnosed with vestibular migraine received a single-session educational and awareness intervention about vestibular migraine. The intervention aimed to improve patients' health beliefs based on the six constructs of the Health Belief Model: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy.

Primary outcomes

  1. Change in Vestibular Migraine Health Belief Scale Score

    Time frame: Immediately before the intervention and immediately after the intervention

    Assessment of change in the total score of the Health Belief Model Scale for Disability and Abilities in Vestibular Migraine Patients following a single-session educational intervention.

    The scale evaluates six constructs of the Health Belief Model:

    perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy.

    The scale consists of Likert-type items scored from 1 to 5, where higher scores indicate stronger health belief levels regarding disability and abilities in vestibular migraine.

Secondary outcomes

  1. Change in Health Belief Model Sub-Dimension Scores

    Time frame: Immediately before the intervention and immediately after the intervention.

    Assessment of changes in the six sub-dimensions of the Health Belief Model Scale for Disability and Abilities in Vestibular Migraine Patients, including: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, self-efficacy. Each sub-dimension is scored using Likert-type items ranging from 1 to 5, with higher scores indicating stronger health belief levels.

Other outcomes

  1. Psychometric Properties of the Vestibular Migraine Health Belief Scale

    Time frame: Baseline assessment

    Evaluation of the psychometric properties of the Health Belief Model Scale for Disability and Abilities in Vestibular Migraine Patients, including: exploratory factor analysis, internal consistency analysis (Cronbach's alpha). These analyses will be conducted to examine the construct validity and reliability of the scale.

  2. Quality of Life in Vestibular Migraine Patients

    Time frame: Baseline assessment.

    Quality of life will be assessed using the World Health Organization Quality of Life Scale - WHOQOL-BREF. The WHOQOL-BREF consists of four domains (physical health, psychological health, social relationships, and environment). Domain scores range from 0 to 100, where higher scores indicate better quality of life.

Sponsors and collaborators

Lead sponsor

Istanbul Aydın University

Other

Registry information

Official study title

Development, Validity and Reliability Study of the Health Belief Model Scale Regarding Disability and Abilities in Vestibular Migraine Patients

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Mar 13, 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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