MedTrace Logo

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

NCT06322550 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2024-03-21

No results posted yet for this study

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 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.

Conditions

  • Role-expectancy on Patient Reported Outcomes

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Hauke Basedau, MD · University Clinic Hamburg

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-29
Primary Completion
2023-02-01
Completion
2023-02-01

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06322550 on ClinicalTrials.gov