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

NCT05378581 | Recruiting

• 2 other identifiers: GIRCI 2020 USCLADE2021-A02125-36
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (3)

• 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

  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

  during procedure (prick test)

• children's pain self-evaluation

  self evaluation of children's pain with the visial analog scale in vertical position quote from 0 to 10, 10=worst score

  5 min after the care

Secondary Outcomes (5)

• change from baseline children's anxiety at just after the care

  before the care and 5 min after the care

• children's anxiety hetero evaluation

  during blood test

• children's anxiety hetero evaluation

  during procedure (prick tests)

• change from baseline parents' anxiety at just after the care

  before the care and 5 min after the care

• evaluation of the care

  5 min after the care

Study Arms (2)

standard

ACTIVE COMPARATOR

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

Other: control arm

virtual reality

EXPERIMENTAL

Use local anesthesic cream and virtual reality mask

Device: Virtual reality mask

Interventions

Virtual reality mask DEVICE

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

virtual reality

control arm OTHER

usual process

standard

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (2)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

CHU de Saint Etienne

Saint-Etienne, 42000, France

RECRUITING

MeSH Terms

Conditions

Pain, Procedural; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Alexandra USCLADE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, open-label, two arms parallel, multicenter therapeutic trial

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 18, 2022
• Study Start: September 23, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)