Virtual Reality Cyber SicknessVRSQ-FNCT06466590
Reliability and Validity of the French Version of the Virtual Reality Sickness Questionnaire
A study testing Use of Measurement Instrument in people with Virtual Reality Cyber Sickness, run by Pôle Saint Hélier at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality Cyber Sickness
- What is being tested?
- Use of Measurement Instrument
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Jul 2024to 14 May 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 :
Show all 10Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre de Rééducation Fonctionnelle Neurologique PROPARA
Montpellier, 34090
Pôle Saint-Hélier
Rennes
Fondation Ildys
Roscoff, 29684
About this study
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
- Being tested
- Use of Measurement Instrument
- Keywords
- virtual reality, cyber sickness, assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Measurement InstrumentDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Use of Measurement Instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Immediately after exercises
Secondary outcomes (1)
Calculate the minimum detectable change in the questionnaire
Clinimetric quality: Calculation of the standard error of measurement SEM and the minimum detectable change MDC
Measured: Immediately after exercises
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start1 Jul 2024
- Primary completion14 May 2025
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual Reality Cyber SicknessStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pôle Saint Hélier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie LEBLONG, Principal investigator, Pôle Saint Hélier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466590
- Sponsor's protocol ID
- 2023-A02468-37
- Acronym
- VRSQ-F
- Status last verified
- May 2025
- First submitted
- 7 Jun 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the French Version of the Virtual Reality Sickness Questionnaire
- ClinicalTrials.gov ID
- NCT06466590
- Acronym / sponsor ID
- VRSQ-F / 2023-A02468-37
- Conditions
- Virtual Reality Cyber Sickness
- Keywords
- virtual reality, cyber sickness, assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 20 Jun 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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Diagnostic Test: Use of Measurement InstrumentParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Men or women aged 18 to 65
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Use of Measurement InstrumentParticipants 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 | Diagnostic test | Single Group |
Primary outcome
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
1 secondary outcome
Calculate the minimum detectable change in the questionnaire
Time frame: Immediately after exercises
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 28 May 2025.
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.
Emilie LEBLONG principal investigator
Pôle Saint Hélier
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Measurement Instrument in people with Virtual Reality Cyber Sickness, run by Pôle Saint Hélier at 3 sites in France.
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 10 inclusion and 8 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 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Check the validity of the VRSQ-F score by comparing it with the SSQ score (time frame: Immediately after exercises). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2025.