Influence of Role-expectancy on Patient Reported Outcomes Among Patients With Migraine: a Randomized Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-29

Study Completion Date

2023-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Role-expectancy on Patient Reported Outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Monocenter, randomized, double blind, three-armed clinical trial

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Double blind

Study Groups

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Migraine Patient

122 migraine patients assigned the role of "patient"

Group Type EXPERIMENTAL

cover story

Intervention Type BEHAVIORAL

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.

Migraine Healthy

122 migraine patients assigned the role of "healthy participant"

Group Type EXPERIMENTAL

cover story

Intervention Type BEHAVIORAL

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.

headache-free controls

122 headache-free controls with no cover story

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cover story

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* migraine patients following ICHD-3 criteria
* headache free controls

Exclusion Criteria

* any other headache or pain disorder
* known somatic or psychiatric disorder
* pregnacy or breast feeding
* known vestibular disorder or whiplash injury

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes