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

NCT ID: NCT05378581

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-23
• Study Completion Date: 2026-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

standard

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

Group Type: ACTIVE_COMPARATOR

control arm

Intervention Type: OTHER

usual process

virtual reality

Use local anesthesic cream and virtual reality mask

Group Type: EXPERIMENTAL

Virtual reality mask

Intervention Type: DEVICE

virtual reality mask Deepsen® with age-appropriate software Birdy®

Interventions

Virtual reality mask

virtual reality mask Deepsen® with age-appropriate software Birdy®

Intervention Type: DEVICE

control arm

usual process

Intervention Type: OTHER

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandra USCLADE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

CHU de Saint Etienne

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lise LACLAUTRE

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Facility Contacts

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Other Identifiers

2021-A02125-36

Identifier Type: OTHER

Identifier Source: secondary_id

GIRCI 2020 USCLADE

Identifier Type: -

Identifier Source: org_study_id