Vestibular MigraineNCT07469748
Health Belief Model Scale Development for Disability and Abilities in Vestibular Migraine Patients
A study testing Vestibular Migraine Education / Awareness Session in people with Vestibular Migraine, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vestibular Migraine
- What is being tested?
- Vestibular Migraine Education / Awareness Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Aydın University
Istanbul, Kucukcekmece, 34295
About this study
Official title: 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.
Read the 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.
- Conditions
- Vestibular Migraine
- Being tested
- Vestibular Migraine Education / Awareness Session
- Keywords
- Vestibular Migraine, Scale Development, Health Belief Model, Reliability, Validity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Migraine Education / Awareness SessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Vestibular Migraine Education / Awareness Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before the intervention and immediately after the intervention
Secondary outcomes (1)
Change in Health Belief Model Sub-Dimension Scores
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.
Measured: Immediately before the intervention and immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Dec 2024
- Primary completion28 Jan 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vestibular MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mümine Görgülü, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469748
- Sponsor's protocol ID
- IstanbulAU-SBF-MG-01
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 21884699Williams 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.
PubMed 22233684Dibbets 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.
PubMed 20604616Glanz K, Rimer BK, Viswanath K. Health Behavior and Health Education: Theory, Research, and Practice. 4th ed. San Francisco: Jossey-Bass; 2008.
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.
PubMed 23142830
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Validity and Reliability Study of the Health Belief Model Scale Regarding Disability and Abilities in Vestibular Migraine Patients
- ClinicalTrials.gov ID
- NCT07469748
- Acronym / sponsor ID
- IstanbulAU-SBF-MG-01
- Conditions
- Vestibular Migraine
- Keywords
- Vestibular Migraine, Scale Development, Health Belief Model, Reliability, Validity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vestibular Migraine Education Intervention | Experimental | Behavioral: Vestibular Migraine Education / Awareness SessionParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular Migraine Education / Awareness SessionParticipants 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. | Behavioural | Vestibular Migraine Education Intervention |
Primary outcome
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.
1 secondary outcome
Change in Health Belief Model Sub-Dimension Scores
Time frame: Immediately before the intervention and immediately after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Results publication: PubMed 21884699Mazarati 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.
- Results publication: PubMed 22233684Williams 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.
- Results publication: PubMed 20604616Dibbets 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.
- Results publicationGlanz K, Rimer BK, Viswanath K. Health Behavior and Health Education: Theory, Research, and Practice. 4th ed. San Francisco: Jossey-Bass; 2008.
- Results publication: PubMed 23142830Lempert 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.
- Vestibular Migraine Diagnostic Criteria (ICHD-3)Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Migraine Education / Awareness Session in people with Vestibular Migraine, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vestibular Migraine Health Belief Scale Score (time frame: Immediately before the intervention and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07469748, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.