Clinical trial NCT05378581: Use of Virtual Reality Mask During Blood and Skin Allergic Tests in 7 to 13 Children
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 300
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, open-label, two arms parallel, multicenter therapeutic trial
Primary purpose: PREVENTION

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: children's pain hetero-evaluation
timeFrame: during blood test
measure: children's pain hetero-evaluation
timeFrame: during procedure (prick test)
measure: children's pain self-evaluation
timeFrame: 5 min after the care
Secondary outcomes:
measure: change from baseline children's anxiety at just after the care
timeFrame: before the care and 5 min after the care
measure: children's anxiety hetero evaluation
timeFrame: during blood test
measure: children's anxiety hetero evaluation
timeFrame: during procedure (prick tests)
measure: change from baseline parents' anxiety at just after the care
timeFrame: before the care and 5 min after the care
measure: evaluation of the care
timeFrame: 5 min after the care
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Saint-Étienne
country: France
facility: CHU de Saint Etienne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Alexandra USCLADE
role: PRINCIPAL_INVESTIGATOR
References: