NCT07469748

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

March 4, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

Vestibular MigraineScale DevelopmentHealth Belief ModelReliabilityValidity

Outcome Measures

Primary Outcomes (1)

  • Change in Vestibular Migraine Health Belief Scale Score

    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 Outcomes (1)

  • Change in Health Belief Model Sub-Dimension Scores

    Immediately before the intervention and immediately after the intervention.

Other Outcomes (2)

  • Psychometric Properties of the Vestibular Migraine Health Belief Scale

    Baseline assessment

  • Quality of Life in Vestibular Migraine Patients

    Baseline assessment.

Study Arms (1)

Vestibular Migraine Education Intervention

EXPERIMENTAL

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.

Behavioral: Vestibular Migraine Education / Awareness Session

Interventions

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.

Vestibular Migraine Education Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydın University

Istanbul, Kucukcekmece, 34295, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    RESULT
  • 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.

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This study used a single-group interventional design. Patients diagnosed with vestibular migraine first completed the Health Belief Model-based scale as a pre-test. Following the baseline assessment, participants received a single-session educational and awareness intervention about vestibular migraine. The intervention focused on improving health belief levels across the six constructs of the Health Belief Model: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy. After the intervention, the scale was administered again as a post-test to evaluate changes in health belief levels.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 13, 2026

Study Start

December 1, 2024

Primary Completion

January 28, 2026

Study Completion

February 28, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to ethical and confidentiality considerations. The data contain sensitive personal health information, and sharing them publicly may compromise participant privacy. Only aggregated and anonymized results will be reported in scientific publications.

Locations