- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07469748
Health Belief Model Scale Development for Disability and Abilities in Vestibular Migraine Patients
Development, Validity and Reliability Study of the Health Belief Model Scale Regarding 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kucukcekmece
-
Istanbul, Kucukcekmece, Turkey (Türkiye), 34295
- Istanbul Aydın University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vestibular Migraine Education Intervention
Participants diagnosed with vestibular migraine received a single-session educational and awareness intervention about vestibular migraine.
The intervention aimed to improve health belief levels based on the six constructs of the Health Belief Model: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy.
The Health Belief Model-based scale was administered before and after the intervention to evaluate changes in health belief levels.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Immediately before the intervention and immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Immediately before the intervention and immediately after the intervention.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline assessment
|
|
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.
|
Baseline assessment.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lempert T, Olesen J, Furman J, Waterston J, Seemungal B, Carey J, Bisdorff A, Versino M, Evers S, Newman-Toker D. Vestibular migraine: diagnostic criteria. J Vestib Res. 2012;22(4):167-72. doi: 10.3233/VES-2012-0453.
- Mazarati A, Maroso M, Iori V, Vezzani A, Carli M. High-mobility group box-1 impairs memory in mice through both toll-like receptor 4 and Receptor for Advanced Glycation End Products. Exp Neurol. 2011 Dec;232(2):143-8. doi: 10.1016/j.expneurol.2011.08.012. Epub 2011 Aug 22.
- Williams G. Aromatase up-regulation, insulin and raised intracellular oestrogens in men, induce adiposity, metabolic syndrome and prostate disease, via aberrant ER-alpha and GPER signalling. Mol Cell Endocrinol. 2012 Apr 4;351(2):269-78. doi: 10.1016/j.mce.2011.12.017. Epub 2012 Jan 5.
- Dibbets P, Evers EA, Hurks PP, Bakker K, Jolles J. Differential brain activation patterns in adult attention-deficit hyperactivity disorder (ADHD) associated with task switching. Neuropsychology. 2010 Jul;24(4):413-23. doi: 10.1037/a0018997.
- Glanz K, Rimer BK, Viswanath K. Health Behavior and Health Education: Theory, Research, and Practice. 4th ed. San Francisco: Jossey-Bass; 2008.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IstanbulAU-SBF-MG-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vestibular Migraine
-
Boston Children's HospitalNot yet recruitingVestibular MigraineUnited States
-
Ege UniversityCompletedVestibular Migraine | Vestibular Disorder | Migraine Variant
-
Boston Children's HospitalNot yet recruitingVestibular Migraine | Chronic Dizziness | Persistent Postural Perceptual DizzinessUnited States
-
Massachusetts Eye and Ear InfirmaryWithdrawnMigraine Disorders | Vestibular Diseases | Vestibular MigraineUnited States
-
Otolith LabsMCRACompletedVestibular Migraine | Migraine Associated VertigoUnited States
-
Otolith LabsMCRACompletedBPPV | Vertigo | Benign Paroxysmal Positional Vertigo | Vestibular Migraine | Vestibular Disorder | Meniere Disease | Ménière's Vertigo | Labrynthitis | Migraine Associated Vertigo | Uncompensated Unilateral VestibulopathyUnited States
-
Assiut UniversityNot yet recruiting
-
First Affiliated Hospital of Jiaxing UniversityNot yet recruiting
-
Vanderbilt University Medical CenterWithdrawnVestibular MigraineUnited States
-
University of California, San FranciscoEli Lilly and CompanyCompleted
Clinical Trials on Vestibular Migraine Education / Awareness Session
-
Boston Children's HospitalNot yet recruitingVestibular MigraineUnited States
-
Wake Forest University Health SciencesNational Center for Complementary and Integrative Health (NCCIH)Recruiting
-
Western Norway University of Applied SciencesHaukeland University HospitalCompletedMusculoskeletal Pain | Rehabilitation | Vestibular DiseaseNorway
-
Ente Ospedaliero Cantonale, BellinzonaRecruiting
-
Mayo ClinicHeart Rhythm SocietyCompleted
-
Baylor College of MedicineCompletedDepression | MigraineUnited States
-
The Miriam HospitalNational Institute of Neurological Disorders and Stroke (NINDS)Completed
-
Albert Einstein College of MedicineNational Center for Advancing Translational Sciences (NCATS)Completed
-
Wake Forest University Health SciencesCompleted
-
Simon GregsonNational Institute of Mental Health (NIMH); University of Copenhagen; London... and other collaboratorsCompleted