Virtual RealityREVAPRICKNCT05378581
Use of Virtual Reality Mask During Blood and Skin Allergic Tests in 7 to 13 Children
A study testing Virtual reality mask in people with Virtual Reality and Children, Only, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
Main objective : Evaluate the effect of using a virtual reality mask during the blood test and pricks tests in allergic children aged from 7 to 13 years. Hypothesis : Using virtual reality mask during blood test and pricks tests for allergic kids from 7 to 13 would reduce anxiety and pain Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Virtual Reality, Children, Only, Pain, Procedural
- What is being tested?
- Virtual reality mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Sep 2022to 30 Apr 2026
- 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 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 7 to 13 years old requiring blood test and prick tests in pediatric consultation at the Clermont-Ferrand University Hospital and in the pediatric's day hospital at the Saint-Etienne University Hospital
- Subjects and their parents who were informed about the study and gave informed consent
- Enrollment in the Social Security system
- Children and parents able to use the self-report scales proposed in the study
Who cannot join
- Children from 7 to 13 :
- presenting a contraindication to the use of the virtual reality mask: heart disease, epilepsy, psychiatric illness (major anxiety, post-traumatic stress disorder)
- Having a modification of pain's integration (spina bifida for example)
- Having received an analgesic before the care
- Requiring contact isolation
- With a history of seizures or motion sickness
- Refusal of the parents and/or the child
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
CHU de Saint Etienne
Saint-Etienne, 42000
About this study
Official title: Evaluation of the Use of a Virtual Reality Mask During Blood Tests and Prick Tests Performed in Allergic Children Aged 7 to 13 Years: a Multicenter, Randomized Trial
Main objective :
Evaluate the effect of using a virtual reality mask during the blood test and pricks tests in allergic children aged from 7 to 13 years.
Hypothesis :
Using virtual reality mask during blood test and pricks tests for allergic kids from 7 to 13 would reduce anxiety and pain
Read the detailed description
Investigation of food or respiratory allergy is based on prick tests and serum specific immunoglobulin E assays. The nurse often controls the blood test pain but during the skin tests, many children cry, feeling both fear and pain. This traumatic experience will in most cases be repeated during the child's allergic follow-up.
To date, there are few effective means of limiting anxiety and pain associated with prick tests and therefore little research work on this subject.
Immersion in virtual reality (VR) seems to be an interesting way of distraction for children from 7 to 13 years needing this treatment. Indeed, it makes it possible to saturate the sensorially of the child thus reducing the nociceptive perceptions and the anxiety. The choice of VR mask with pediatric program specific seems interesting for this children This is a randomized, open-label, two-armed parallel, multicenter therapeutic trial comparing an analgesic strategy using authorized medical devices (conventional strategy) with a virtual reality mask distraction technique for allergics tests in children from 7 to 13 years old hospitalized in the pediatric consultation of Clermont Ferrand University Hospital and in the day hospital of Saint-Etienne University Hospital
The control arm is the local anesthetic cream (for the blood test) arm with distraction from nurse/parents +/-anesthesic and anxiolytic gas and the experimental arm is the local anesthetic cream + virtual reality mask distraction
The nurse informs and obtains the consent of the child and his parents. Then she measures child's pain and anxiety before the care, during the blood test, at the third prick test and immediately after the care.
She also notes the anxiety of the parents before and after the care. Finally, the satisfaction of the child, parents, nurses will be collected at the end of the care.
After statistical analysis of these two arms, it will be possible to determine the value of the virtual reality mask to reduce the child's pain and anxiety during the pricks tests.
- Conditions
- Virtual Reality, Children, Only, Pain, Procedural, Anxiety and Fear
- Being tested
- Virtual reality mask, control arm
- Keywords
- virtual reality mask, children from 7 to 13, allergic pricks tests, consultation and pediatric's day hospital
- Medical subject headings
- Pain, Procedural, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality maskDevice
virtual reality mask Deepsen® with age-appropriate software Birdy®
control armOther
usual process
| Study group | Role | What they receive |
|---|---|---|
| standard | Active comparator | Use local anesthesic cream + nurse or parents distraction +/- anesthesic or anxiolytic gas Receives: Other: control arm |
| virtual reality | Experimental | Use local anesthesic cream and virtual reality mask Receives: Device: Virtual reality mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
children's pain hetero-evaluation
children's pain evaluation by the nurse with the visual analog scale quote from 0 to 10, 10=worst score
Measured: during blood test
children's pain hetero-evaluation
children's pain evaluation by the nurse with the visual analog scale from 0 to 10, 10= worst score
Measured: during procedure (prick test)
children's pain self-evaluation
self evaluation of children's pain with the visual analog scale in vertical position quote from 0 to 10, 10=worst score
Measured: 5 min after the care
Secondary outcomes (5)
change from baseline children's anxiety at just after the care
self-evaluation of children's anxiety with the scale "child fear scale" quote from 0 to 4, 4= worst score
Measured: before the care and 5 min after the care
children's anxiety hetero evaluation
children's anxiety evaluation by the nurse with the scale "child fear scale" quote from 0 to 4, 4= worst score
Measured: during blood test
children's anxiety hetero evaluation
children's anxiety evaluation by the nurse with the scale "child fear scale" quote from 0 to 4, 4= worst score
Measured: during procedure (prick tests)
change from baseline parents' anxiety at just after the care
self-evaluation of parents' anxiety with the numerical scale quote from 1 to 10, 10= worst score
Measured: before the care and 5 min after the care
evaluation of the care
satisfaction of the care for children, parents and nurses with satisfaction questionnaire for children : a score from 1 to 3 (3=best score, very satisfied) for parents with a score from 1 to 5 (5= best score, very satisfied) and for nurse with a score from 1 to 5 (5= best score, very satisfied)
Measured: 5 min after the care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start23 Sep 2022
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, open-label, two arms parallel, multicenter therapeutic trial
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra USCLADE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378581
- Sponsor's protocol ID
- GIRCI 2020 USCLADE
- Other IDs
- 2021-A02125-36
- Acronym
- REVAPRICK
- Status last verified
- May 2026
- First submitted
- 2 May 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of a Virtual Reality Mask During Blood Tests and Prick Tests Performed in Allergic Children Aged 7 to 13 Years: a Multicenter, Randomized Trial
- ClinicalTrials.gov ID
- NCT05378581
- Acronym / sponsor ID
- REVAPRICK / GIRCI 2020 USCLADE
- Conditions
- Virtual Reality, Children, Only, Pain, Procedural, Anxiety and Fear
- Keywords
- virtual reality mask, children from 7 to 13, allergic pricks tests, consultation and pediatric's day hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 18 May 2022 (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.
Main objective :
Evaluate the effect of using a virtual reality mask during the blood test and pricks tests in allergic children aged from 7 to 13 years.
Hypothesis :
Using virtual reality mask during blood test and pricks tests for allergic kids from 7 to 13 would reduce anxiety and pain
Detailed description
Investigation of food or respiratory allergy is based on prick tests and serum specific immunoglobulin E assays. The nurse often controls the blood test pain but during the skin tests, many children cry, feeling both fear and pain. This traumatic experience will in most cases be repeated during the child's allergic follow-up.
To date, there are few effective means of limiting anxiety and pain associated with prick tests and therefore little research work on this subject.
Immersion in virtual reality (VR) seems to be an interesting way of distraction for children from 7 to 13 years needing this treatment. Indeed, it makes it possible to saturate the sensorially of the child thus reducing the nociceptive perceptions and the anxiety. The choice of VR mask with pediatric program specific seems interesting for this children This is a randomized, open-label, two-armed parallel, multicenter therapeutic trial comparing an analgesic strategy using authorized medical devices (conventional strategy) with a virtual reality mask distraction technique for allergics tests in children from 7 to 13 years old hospitalized in the pediatric consultation of Clermont Ferrand University Hospital and in the day hospital of Saint-Etienne University Hospital
The control arm is the local anesthetic cream (for the blood test) arm with distraction from nurse/parents +/-anesthesic and anxiolytic gas and the experimental arm is the local anesthetic cream + virtual reality mask distraction
The nurse informs and obtains the consent of the child and his parents. Then she measures child's pain and anxiety before the care, during the blood test, at the third prick test and immediately after the care.
She also notes the anxiety of the parents before and after the care. Finally, the satisfaction of the child, parents, nurses will be collected at the end of the care.
After statistical analysis of these two arms, it will be possible to determine the value of the virtual reality mask to reduce the child's pain and anxiety during the pricks tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, open-label, two arms parallel, multicenter therapeutic trial
| Arm | Type | Receives |
|---|---|---|
| standard | Active comparator | Other: control armUse local anesthesic cream + nurse or parents distraction +/- anesthesic or anxiolytic gas |
| virtual reality | Experimental | Device: Virtual reality maskUse local anesthesic cream and virtual reality mask |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children from 7 to 13 years old requiring blood test and prick tests in pediatric consultation at the Clermont-Ferrand University Hospital and in the pediatric's day hospital at the Saint-Etienne University Hospital
- Subjects and their parents who were informed about the study and gave informed consent
- Enrollment in the Social Security system
- Children and parents able to use the self-report scales proposed in the study
Key exclusion criteria (7 listed)
- presenting a contraindication to the use of the virtual reality mask: heart disease, epilepsy, psychiatric illness (major anxiety, post-traumatic stress disorder)
- Having a modification of pain's integration (spina bifida for example)
- Having received an analgesic before the care
- Requiring contact isolation
- With a history of seizures or motion sickness
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 maskvirtual reality mask Deepsen® with age-appropriate software Birdy® | Device | virtual reality |
| control armusual process | Other | standard |
Primary outcome
children's pain hetero-evaluation
Time frame: during blood test
children's pain evaluation by the nurse with the visual analog scale quote from 0 to 10, 10=worst score
children's pain hetero-evaluation
Time frame: during procedure (prick test)
children's pain evaluation by the nurse with the visual analog scale from 0 to 10, 10= worst score
children's pain self-evaluation
Time frame: 5 min after the care
self evaluation of children's pain with the visual analog scale in vertical position quote from 0 to 10, 10=worst score
5 secondary outcomes
change from baseline children's anxiety at just after the care
Time frame: before the care and 5 min after the care
children's anxiety hetero evaluation
Time frame: during blood test
children's anxiety hetero evaluation
Time frame: during procedure (prick tests)
change from baseline parents' anxiety at just after the care
Time frame: before the care and 5 min after the care
evaluation of the care
Time frame: 5 min after the care
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 8 May 2026.
- Individual participant dataSharing planned: No
Related trials for Virtual Reality
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
Not yet recruiting
Virtual Reality Training Dose for Arm Recovery After Stroke: Clinical and Blood Biomarker Responses
Stroke, Upper Extremity Paresis
Recruiting
Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
Traumatic Brain Injury
Not yet recruiting
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
Physical Activity, Intellectual Disabilities
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.
Alexandra USCLADE principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality mask in people with Virtual Reality and Children, Only, run by University Hospital, Clermont-Ferrand at 2 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 4 inclusion and 7 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 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
children's pain hetero-evaluation (time frame: during blood test). The study lists 3 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 8 May 2026.