Role-expectancy on Patient Reported OutcomesNCT06322550
Influence of Role-expectancy on Patient Reported Outcomes Among Patients With Migraine: a Randomized Clinical Trial
A study testing cover story in people with Role-expectancy on Patient Reported Outcomes, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This study was preregistered 2019 under https://osf.io/nczhj. Since JAMA requires a registration with ClinicalTrials.gov, we post-register the study here with the identical informations from OSF (see there) Migraine is frequently associated with motion sickness, vestibular symptoms, and abnormal motion and visual… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Role-expectancy on Patient Reported Outcomes
- What is being tested?
- cover story
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteGermany
- Study dates
- 29 Oct 2019to 1 Feb 2023
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- migraine patients following ICHD-3 criteria
- headache free controls
Who cannot join
- any other headache or pain disorder
- known somatic or psychiatric disorder
- pregnacy or breast feeding
- known vestibular disorder or whiplash injury
Trial locations and contacts
1 site in 1 country.
About this study
This study was preregistered 2019 under https://osf.io/nczhj. Since JAMA requires a registration with ClinicalTrials.gov, we post-register the study here with the identical informations from OSF (see there)
Migraine is frequently associated with motion sickness, vestibular symptoms, and abnormal motion and visual processing. Clinical symptoms and underlying brain mechanisms during self-motion visual stimulation were not yet investigated in this population. Therefore the aim is to investigate the behavioral responses from a visually simulated roller coaster ride of patients with migraine and headache-free controls. In order to verify the effect of response bias, part of the patients with migraine will be informed that the study aims to investigate vestibular disorders instead of headache disorders and that they are invited as healthy controls.
Read the detailed description
We have a three group randomized controlled design. Migraine patients from the headache outpatient clinic will randomly be assigned to get two different cover stories via a flyer with study information and through the physician from the outpatient clinic: 50% of patients will receive the information that they will take part to investigate migraine (by watching the visual stimulus (roller coaster video)). The other 50% will receive the information that they will take part as healthy controls for a headache unrelated study (by watching the visual stimulus (roller coaster video)). Sex and age matched healthy controls will take part in the same experiment and get no additional information but that we investigate the perception of a visual stimulus (roller coaster video). The protocol for the intervention is standardized and identical for all participants.
Migraine patients will be randomly given the priming information and therefore their group allocation. Physicians will allocate by pulling from a randomized equally sized stock of flyers (of which 50% inform for healthy controls and 50% for migraine patients).
Migraine Patients for both migraine groups will be recruited and diagnosed by a neurologist from the UKE headache outpatient clinic. Healthy controls will be recruited via an internet platform for job advertisement. Participants will be paid 10€ for participation. Participants must be at least 18 years old and have signed the informed consent. They are excluded if they have 1. History of any neurological disease, 2. Self-report of diagnosis of vestibular disease, 3. History of trauma or pathology of the cervical spine (e.g., whiplash associated disorder), 4. Pregnancy, 5. Other relevant musculoskeletal, systemic or psychiatric disease.
- Being tested
- cover story
- Keywords
- migraine, role expectation, outcomes, social role, response bias, subjective pain reporting
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cover storyBehavioural
After agreeing to participate, migraine patients were randomly given the briefing information and therefore their group allocation. Patients received the cover stories via the allocated flyer with study information and also by the physician from the outpatient clinic. Fifty percent of patients (Migraine as Patients [MP]) received the information that they will take part in a migraine study (compared to healthy controls) and that this study would investigates migraine associated dizziness by watching a visual stimulus (roller coaster video). The protocol for the intervention was standardized and identical for all participants. The other 50% (Migraine as Healthy [MH]) received the information that this study was in cooperation with the University's vertigo Department and that they will take part as controls since they were healthy apart from their migraine.
| Study group | Role | What they receive |
|---|---|---|
| Migraine Patient | Experimental | 122 migraine patients assigned the role of "patient" Receives: Behavioral: cover story |
| Migraine Healthy | Experimental | 122 migraine patients assigned the role of "healthy participant" Receives: Behavioral: cover story |
| headache-free controls | No intervention | 122 headache-free controls with no cover story |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported vestibular symptoms
Patients were encouraged to describe their symptoms according to the Barany's Classification of Vestibular Disorders including its form (internal/external vertigo, dizziness or postural symptoms). Outcome was frequency of occurence of vestibular symptoms classified according to the Barany's Classification.
Measured: 1 time point: study day1
Secondary outcomes (4)
differences in motion sickness susceptibility using a standardized motion sickness questionnaire
Motion sickness susceptibility was tested using the MSSQ- short version questionnaire. The outcome is a sum score.
Measured: 1 time point: study day1
differences in disability level using a standardized motion sickness questionnaire
The disability level related to vestibular symptoms was assessed using the Dizziness Handicap Inventory (DHI-G). The outcome is a sum score.
Measured: 1 time point: study day1
differences in headache days per month
The self-report of headache frequency/month was tested.
Measured: 1 time point: study day1
differences in headache burden and migraine disability questionnaires
All participants filled out a questionnaire (migraine disability assessment score - MIDAS) The outcome is a sum-score
Measured: 1 time point: study day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start29 Oct 2019
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Role-expectancy on Patient Reported OutcomesStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocenter, randomized, double blind, three-armed clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hauke Basedau, MD, Principal investigator, University Clinic Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322550
- Sponsor's protocol ID
- beingapatient
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers meeting the criteria for access to confidential data may access the data upon request, involving the documentation of data access
Publications
May A, Carvalho GF, Schwarz A, Basedau H. Influence of Role Expectancy on Patient-Reported Outcomes Among Patients With Migraine: A Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e243223. doi: 10.1001/jamanetworkopen.2024.3223.
PubMed 38656579
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Role-expectancy on Patient Reported Outcomes Among Patients With Migraine: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06322550
- Acronym / sponsor ID
- beingapatient
- Keywords
- migraine, role expectation, outcomes, social role, response bias, subjective pain reporting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 21 Mar 2024 (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.
This study was preregistered 2019 under https://osf.io/nczhj. Since JAMA requires a registration with ClinicalTrials.gov, we post-register the study here with the identical informations from OSF (see there)
Migraine is frequently associated with motion sickness, vestibular symptoms, and abnormal motion and visual processing. Clinical symptoms and underlying brain mechanisms during self-motion visual stimulation were not yet investigated in this population. Therefore the aim is to investigate the behavioral responses from a visually simulated roller coaster ride of patients with migraine and headache-free controls. In order to verify the effect of response bias, part of the patients with migraine will be informed that the study aims to investigate vestibular disorders instead of headache disorders and that they are invited as healthy controls.
Detailed description
We have a three group randomized controlled design. Migraine patients from the headache outpatient clinic will randomly be assigned to get two different cover stories via a flyer with study information and through the physician from the outpatient clinic: 50% of patients will receive the information that they will take part to investigate migraine (by watching the visual stimulus (roller coaster video)). The other 50% will receive the information that they will take part as healthy controls for a headache unrelated study (by watching the visual stimulus (roller coaster video)). Sex and age matched healthy controls will take part in the same experiment and get no additional information but that we investigate the perception of a visual stimulus (roller coaster video). The protocol for the intervention is standardized and identical for all participants.
Migraine patients will be randomly given the priming information and therefore their group allocation. Physicians will allocate by pulling from a randomized equally sized stock of flyers (of which 50% inform for healthy controls and 50% for migraine patients).
Migraine Patients for both migraine groups will be recruited and diagnosed by a neurologist from the UKE headache outpatient clinic. Healthy controls will be recruited via an internet platform for job advertisement. Participants will be paid 10€ for participation. Participants must be at least 18 years old and have signed the informed consent. They are excluded if they have 1. History of any neurological disease, 2. Self-report of diagnosis of vestibular disease, 3. History of trauma or pathology of the cervical spine (e.g., whiplash associated disorder), 4. Pregnancy, 5. Other relevant musculoskeletal, systemic or psychiatric disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Monocenter, randomized, double blind, three-armed clinical trial
| Arm | Type | Receives |
|---|---|---|
| Migraine Patient | Experimental | Behavioral: cover story122 migraine patients assigned the role of "patient" |
| Migraine Healthy | Experimental | Behavioral: cover story122 migraine patients assigned the role of "healthy participant" |
| headache-free controls | No intervention | –122 headache-free controls with no cover story |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- migraine patients following ICHD-3 criteria
- headache free controls
Key exclusion criteria (4 listed)
- any other headache or pain disorder
- known somatic or psychiatric disorder
- pregnacy or breast feeding
- known vestibular disorder or whiplash injury
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 |
|---|---|---|
| cover storyAfter agreeing to participate, migraine patients were randomly given the briefing information and therefore their group allocation. Patients received the cover stories via the allocated flyer with study information and also by the physician from the outpatient clinic. Fifty percent of patients (Migraine as Patients [MP]) received the information that they will take part in a migraine study (compared to healthy controls) and that this study would investigates migraine associated dizziness by watching a visual stimulus (roller coaster video). The protocol for the intervention was standardized and identical for all participants. The other 50% (Migraine as Healthy [MH]) received the information that this study was in cooperation with the University's vertigo Department and that they will take part as controls since they were healthy apart from their migraine. | Behavioural | Migraine Healthy, Migraine Patient |
Primary outcome
self-reported vestibular symptoms
Time frame: 1 time point: study day1
Patients were encouraged to describe their symptoms according to the Barany's Classification of Vestibular Disorders including its form (internal/external vertigo, dizziness or postural symptoms). Outcome was frequency of occurence of vestibular symptoms classified according to the Barany's Classification.
4 secondary outcomes
differences in motion sickness susceptibility using a standardized motion sickness questionnaire
Time frame: 1 time point: study day1
differences in disability level using a standardized motion sickness questionnaire
Time frame: 1 time point: study day1
differences in headache days per month
Time frame: 1 time point: study day1
differences in headache burden and migraine disability questionnaires
Time frame: 1 time point: study day1
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 21 Mar 2024.
- Derived from this study: PubMed 38656579May A, Carvalho GF, Schwarz A, Basedau H. Influence of Role Expectancy on Patient-Reported Outcomes Among Patients With Migraine: A Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e243223. doi: 10.1001/jamanetworkopen.2024.3223.
- Individual participant dataSharing planned: Yes. Researchers meeting the criteria for access to confidential data may access the data upon request, involving the documentation of data access
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.
Hauke Basedau, MD principal investigator
University Clinic Hamburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cover story in people with Role-expectancy on Patient Reported Outcomes, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 2 inclusion and 4 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 21 Mar 2024. 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 Germany. 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?
self-reported vestibular symptoms (time frame: 1 time point: study day1). 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 NCT06322550, which also lists 1 linked publication.
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 21 Mar 2024.