Completed

NCT Number: NCT06466590

Reliability and Validity of the French Version of the Virtual Reality Sickness Questionnaire

This is a multicenter, controlled, non-randomized interventional clinical study, with minimal risks and constraints, aimed at verifying the reliability of the French version of the VRSQ questionnaire (VRSQ-F) and the validity of the VRSQ-F score by comparing it with the SSQ score.

Completed

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Key information

Conditions

Virtual Reality Cyber Sickness

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Rééducation Fonctionnelle Neurologique PROPARA, Montpellier, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For Healthy people :

Men or women aged 18 to 65
Person affiliated to a social security scheme
Healthy person with no particular medical condition
Having given their consent to participate in the research

For patients :

Men or women aged 18 to 65
Persons affiliated to a social security scheme
People undergoing regular rehabilitation, walking or in a wheelchair, who can use a virtual reality solution as part of their care.
Having given their consent to take part in the research

Exclusion criteria

Vestibular and cardiac pathologies, and major visual disorders not compatible with virtual reality rehabilitation
Cognitive and language disorders
Persons under legal protection
Pregnant women
MSSQ greater than 15
People suffering from photosensitive epilepsy
Persons under the influence of medication that may impair drugs or alcohol
Participant with an implanted medical device that may be affected by radio waves emitted by compatible third-party equipment (e.g. : Pacemaker)

Treatment and study plan

Use of Measurement Instrument

Diagnostic Test

Participants will complete the measurement procedure twice, with sessions scheduled one week apart, using the same instrument under standardized conditions. The results from both sessions will be compared to assess the instrument's consistency and accuracy

Primary outcomes

Check the validity of the VRSQ-F score by comparing it with the SSQ score

Time frame: Immediately after exercises

Criteria validity between SSQ and VRSQ-F. SSQ questionnaire with 16 questions scoring from 0 to 48 VRSQ-F questionnaire with 9 questions from 0 to 27
Reliability of VRSQ-F (Virtual Reality Sickness Questionnaire) using the intraclass correlation coefficient between measurements immediately after VR exercises and 15 min after and Cronbach coefficient of the VRSQ-F questionnaire

Time frame: Immediately after exercises

Reliability of VRSQ-F (Virtual Reality Sickness Questionnaire) using the intraclass correlation coefficient between measurements immediately after VR exercises and 15 min after and Cronbach coefficient of the VRSQ-F questionnaire

Secondary outcomes

Calculate the minimum detectable change in the questionnaire

Time frame: Immediately after exercises

Clinimetric quality: Calculation of the standard error of measurement SEM and the minimum detectable change MDC

Sponsors and collaborators

Lead sponsor

Pôle Saint Hélier

Other

Registry information

Acronym: VRSQ-F

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jun 20, 2024
Registry last updated: May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.