Sickness BehaviorNCT04483999
Turkish Validity and Reliability Study of Virtual Reality Sickness Questionnaire
An observational study of Sickness Behavior, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study is planned for the cultural adaptation and validity of the "Virtual Reality Sickness Questionnaire". Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickness Behavior
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2021to 30 Mar 2023
- Phase
- Observational
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy people
Who may be able to join
- Not having mental - cognitive problems,
- Being a volunteer
Who cannot join
- Oculomotor and vestibular disease
- Cardiovascular, neurological and gastrointestinal problems
Trial locations and contacts
1 site in 1 country.
About this study
This study is planned for the cultural adaptation and validity of the "Virtual Reality Sickness Questionnaire".
Read the detailed description
Virtual reality (SG) creates a virtual environment that reflects a real environment and offers various experiences to users. Motion sickness can be observed in people after using virtual reality applications or simulation devices in education. There are questionnaires in the literature such as "Simulator Sickness Questionnaire" and "Motion Sickness Questionnaire". However, these questionnaires are specific surveys to evaluate symptoms that develop after vehicle handling or use of simulation devices for pilot training, while they are not ideal questionnaires to evaluate symptoms that may develop after virtual reality applications. Because there are important differences between virtual reality systems and simulation systems in terms of the appearance of motion disturbance symptoms. For this reason, "Virtual Reality Sickness Questionnaire" has been developed that can evaluate these symptoms.
There is no Turkish version of the "Virtual Reality Sickness Questionnaire" in the literature. For this reason, this study is planned for the cultural adaptation and validity of the "Virtual Reality Sickness Questionnaire".
- Conditions
- Sickness Behavior
- Keywords
- virtual reality, sickness, validity, reliability, turkish
- Medical subject headings
- Illness Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Virtual Reality Sickness Questionnaire
This questionnaire assess virtual reality sickness. This questionnaire consists of 2 subtitles as oculomotor and disorientation. It contains 9 symptoms in total. Each symptom is scored between 0 and 3 with the Likert type scoring system. Each subtitle adapted to be calculated by dividing the total score to a score system in itself like person receives%. The total score of the questionnaire will be obtained by averaging the total scores of the two subtitles.
Measured: Change from Baseline sickness after 1 hour later.
graybiel scale
This questionnaire assess virtual reality sickness. Total score ranges from 0-50. 0-2 points are interpreted as "light susceptibility to motion sickness", 3-7 points as "moderate susceptibility to motion sickness", 8-15 points as "extreme susceptibility to motion sickness", and values above 16 are "Definitive motion sickness".
Measured: Change from Baseline sickness after 1 hour later.
Secondary outcomes (2)
international physical activity questionnaire
This questionnaire assess physical activity level. The physical activity levels are classified as (< 600 MET-min/week), which is the physically inactive level (level I); (600-3000 METmin/week), which is the level in medium-level (level II) and (> 3000 MET-min/week), which is the high physical activity level.
Measured: All of the participants will assess at baseline with this scale.
tampa kinesiophobia scale
This questionnaire assess kinesiophobia. The four-point Likert scoring is used in this scale (1 = I do not agree at all, 4 = I agree completely). The total score is calculated after reversing the items 4, 8, 12 and 16. Scoring ranges between 17 and 68 with the higher scores indicating higher levels of kinesiophobia perception.
Measured: All of the participants will assess at baseline with this scale.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start30 Jun 2021
- Primary completion30 Jan 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickness BehaviorStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HATİCE ÇETİN, Hacettepe University
- Investigators
- NEZİRE KOSE, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483999
- Sponsor's protocol ID
- VRSQ9
- Status last verified
- Apr 2023
- First submitted
- 20 Jul 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim HK, Park J, Choi Y, Choe M. Virtual reality sickness questionnaire (VRSQ): Motion sickness measurement index in a virtual reality environment. Appl Ergon. 2018 May;69:66-73. doi: 10.1016/j.apergo.2017.12.016. Epub 2018 Jan 16.
PubMed 29477332
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability Study of Virtual Reality Sickness Questionnaire
- ClinicalTrials.gov ID
- NCT04483999
- Acronym / sponsor ID
- VRSQ9
- Conditions
- Sickness Behavior
- Keywords
- virtual reality, sickness, validity, reliability, turkish
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 23 Jul 2020 (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 study is planned for the cultural adaptation and validity of the "Virtual Reality Sickness Questionnaire".
Detailed description
Virtual reality (SG) creates a virtual environment that reflects a real environment and offers various experiences to users. Motion sickness can be observed in people after using virtual reality applications or simulation devices in education. There are questionnaires in the literature such as "Simulator Sickness Questionnaire" and "Motion Sickness Questionnaire". However, these questionnaires are specific surveys to evaluate symptoms that develop after vehicle handling or use of simulation devices for pilot training, while they are not ideal questionnaires to evaluate symptoms that may develop after virtual reality applications. Because there are important differences between virtual reality systems and simulation systems in terms of the appearance of motion disturbance symptoms. For this reason, "Virtual Reality Sickness Questionnaire" has been developed that can evaluate these symptoms.
There is no Turkish version of the "Virtual Reality Sickness Questionnaire" in the literature. For this reason, this study is planned for the cultural adaptation and validity of the "Virtual Reality Sickness Questionnaire".
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy people
Key inclusion criteria (2 listed)
- Not having mental - cognitive problems,
- Being a volunteer
Key exclusion criteria (2 listed)
- Oculomotor and vestibular disease
- Cardiovascular, neurological and gastrointestinal problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Virtual Reality Sickness Questionnaire
Time frame: Change from Baseline sickness after 1 hour later.
This questionnaire assess virtual reality sickness. This questionnaire consists of 2 subtitles as oculomotor and disorientation. It contains 9 symptoms in total. Each symptom is scored between 0 and 3 with the Likert type scoring system. Each subtitle adapted to be calculated by dividing the total score to a score system in itself like person receives%. The total score of the questionnaire will be obtained by averaging the total scores of the two subtitles.
graybiel scale
Time frame: Change from Baseline sickness after 1 hour later.
This questionnaire assess virtual reality sickness. Total score ranges from 0-50. 0-2 points are interpreted as "light susceptibility to motion sickness", 3-7 points as "moderate susceptibility to motion sickness", 8-15 points as "extreme susceptibility to motion sickness", and values above 16 are "Definitive motion sickness".
2 secondary outcomes
international physical activity questionnaire
Time frame: All of the participants will assess at baseline with this scale.
tampa kinesiophobia scale
Time frame: All of the participants will assess at baseline with this scale.
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 18 Apr 2023.
- Background: PubMed 29477332Kim HK, Park J, Choi Y, Choe M. Virtual reality sickness questionnaire (VRSQ): Motion sickness measurement index in a virtual reality environment. Appl Ergon. 2018 May;69:66-73. doi: 10.1016/j.apergo.2017.12.016. Epub 2018 Jan 16.
- URLLink provided by the sponsor.
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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.
NEZİRE KOSE principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickness Behavior, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Virtual Reality Sickness Questionnaire (time frame: Change from Baseline sickness after 1 hour later.). 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?
On the ClinicalTrials.gov record for NCT04483999, which also lists 1 linked publication.
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 18 Apr 2023.