Use of Virtual Reality Mask During Blood and Skin Allergic Tests in 7 to 13 Children (REVAPRICK)

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Anxiety and Fear; Children, Only; Virtual Reality; Pain, Procedural

Treatments: Other: control arm; Device: Virtual reality mask

Study type: Interventional

Funder types: Other

Identifiers

NCT05378581

2021-A02125-36 (Other Identifier)

GIRCI 2020 USCLADE

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 7 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

standard

Active Comparator group

Description:

Use local anesthesic cream + nurse or parents distraction +/- anesthesic or anxiolytic gas

Treatment:

Other: control arm

virtual reality

Experimental group

Description:

Use local anesthesic cream and virtual reality mask

Treatment:

Device: Virtual reality mask