ClaustrophobiaLIVENCT04536116
Virtual Reality As Anxiety Management Tool for Preparing Children for MR Exam
A study testing Virtual Reality headset in people with Claustrophobia, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The access to MRI examination is limited due to the duration of the acquisitions, the noise and the narrow patient space of the device. A child can, therefore, be anxious, less cooperative and move more during the acquisition, affecting the quality of the examination and the medical diagnosis. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Claustrophobia
- What is being tested?
- Virtual Reality headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2020to 18 Oct 2023
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child from 6 to 12 years old,
- Child who will have an MRI for the first time,
- Outpatient child,
- Child dependent on a parent affiliated to or beneficiary of a social security scheme,
- Child who has received age-appropriate information on the organization of the research,
- Child whose parents (or the only parent present with parental authority) have been fully informed about the organization of the research and have signed informed consent.
Who cannot join
- Conditions that not allow the realization of a virtual MRI sceanrio or not allow to respond the scales (epilepsy, mental disorders, language, ...),
- Child with a contraindication to performing an MRI,
- Child who has benefited from another MRI simulation system before ("IRM en Jeu" for instance)
- Child's opposition to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EvaLuation De L'apport De L'Irm Virtuelle Sur La Qualité De La Prise En Charge Des Enfants En Irm
The access to MRI examination is limited due to the duration of the acquisitions, the noise and the narrow patient space of the device. A child can, therefore, be anxious, less cooperative and move more during the acquisition, affecting the quality of the examination and the medical diagnosis. General anesthesia or sedation, may be considered to obtain diagnostic quality examinations. Our hypothesis is that a scenario as close as possible to reality to prepare children before the MR exam could reduce their anxiety, improve the quality of the exams and reduce its duration.
The purpose of this study is to evaluate the effect of virtual reality on MRI exam preparation to reduce the anxiety of children (aged from 6 to 12 years) who are referred to their first MRI exam, as compared to the current practice.
- Conditions
- Claustrophobia
- Being tested
- Virtual Reality headset
- Medical subject headings
- Claustrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality headsetDevice
MRI simulation with a Virtual Reality headset
| Study group | Role | What they receive |
|---|---|---|
| MRI simulation | Experimental | MRI simulation with a Virtual Reality headset Receives: Device: Virtual Reality headset |
| Standard medical care | No intervention | Standard medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Anxiety measurement before and after MRI by Visual Analogue Scale between 0 and 10
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start4 Nov 2020
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClaustrophobiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Servait Coralie, Central Hospital, Nancy, France
- Investigators
- Coralie SERVAIT, PI, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536116
- Sponsor's protocol ID
- 2019-A03072-55
- Acronym
- LIVE
- Status last verified
- Feb 2024
- First submitted
- 5 Aug 2020
- Last updated
- 30 Jan 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 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EvaLuation De L'apport De L'Irm Virtuelle Sur La Qualité De La Prise En Charge Des Enfants En Irm
- ClinicalTrials.gov ID
- NCT04536116
- Acronym / sponsor ID
- LIVE / 2019-A03072-55
- Conditions
- Claustrophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 2 Sep 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.
The access to MRI examination is limited due to the duration of the acquisitions, the noise and the narrow patient space of the device. A child can, therefore, be anxious, less cooperative and move more during the acquisition, affecting the quality of the examination and the medical diagnosis. General anesthesia or sedation, may be considered to obtain diagnostic quality examinations. Our hypothesis is that a scenario as close as possible to reality to prepare children before the MR exam could reduce their anxiety, improve the quality of the exams and reduce its duration.
The purpose of this study is to evaluate the effect of virtual reality on MRI exam preparation to reduce the anxiety of children (aged from 6 to 12 years) who are referred to their first MRI exam, as compared to the current practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI simulation | Experimental | Device: Virtual Reality headsetMRI simulation with a Virtual Reality headset |
| Standard medical care | No intervention | –Standard medical care |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child from 6 to 12 years old,
- Child who will have an MRI for the first time,
- Outpatient child,
- Child dependent on a parent affiliated to or beneficiary of a social security scheme,
- Child who has received age-appropriate information on the organization of the research,
Key exclusion criteria (4 listed)
- Conditions that not allow the realization of a virtual MRI sceanrio or not allow to respond the scales (epilepsy, mental disorders, language, ...),
- Child with a contraindication to performing an MRI,
- Child who has benefited from another MRI simulation system before ("IRM en Jeu" for instance)
- Child's opposition to participate.
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 |
|---|---|---|
| Virtual Reality headsetMRI simulation with a Virtual Reality headset | Device | MRI simulation |
Primary outcome
Anxiety
Time frame: 2 hours
Anxiety measurement before and after MRI by Visual Analogue Scale between 0 and 10
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 30 Jan 2025.
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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.
Coralie SERVAIT, PI principal investigator
CHRU de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality headset in people with Claustrophobia, run by Central Hospital, Nancy, France at 1 site 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 6 inclusion and 4 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 30 Jan 2025. 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 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?
Anxiety (time frame: 2 hours). 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 30 Jan 2025.