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

NCT06466590 | Completed

• 1 other identifier: 2023-A02468-37
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Virtual Reality Cyber Sickness

Keywords

virtual reality; cyber sickness; assessment

Outcome Measures

Primary Outcomes (2)

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

  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

  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

  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

  Immediately after exercises

Secondary Outcomes (1)

• Calculate the minimum detectable change in the questionnaire

  Immediately after exercises

Study Arms (1)

Single Group

EXPERIMENTAL

Participants will be asked to use the measurement instrument VRSQ-F on two separate occasions under identical conditions to assess its test-retest reliability and asked to use the SSQ for validity. Each session will involve completing the measurement protocol as specified.

Diagnostic Test: Use of Measurement Instrument

Interventions

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

Single Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pôle Saint Hélier: lead

Study Sites (3)

Centre de Rééducation Fonctionnelle Neurologique PROPARA

Montpellier, 34090, France

Location

Pôle Saint-Hélier

Rennes, France

Location

Fondation Ildys

Roscoff, 29684, France

Location

Study Officials

• Emilie LEBLONG

  Pôle Saint Hélier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will perform 4 exercises in virtual reality with HMD (Head Mounted Display). Then, they will use the VRSQ-F instrument under study on 2 times separated by 15 minutes. The primary objective is to assess the reliability and validity of this instrument through repeated measures and comparison to SSQ

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 20, 2024
• Study Start: July 1, 2024
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

FR (3)