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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Testicular Diseases; Pain, Procedural; Virtual Reality; Children, Only; Anxiety and Fear
• Intervention / Treatment: Other: control arm; Device: Virtual reality mask

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand
  • Saint-Étienne, France, 42000
    • CHU de Saint Etienne
    • Principal Investigator: Christine REDURON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: standard; Use local anesthesic cream + nurse or parents distraction +/- anesthesic or anxiolytic gas	Other: control arm; usual process
EXPERIMENTAL: virtual reality; Use local anesthesic cream and virtual reality mask	Device: Virtual reality mask; virtual reality mask Deepsen® with age-appropriate software Birdy®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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)	5 min after the care

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2022
• Primary Completion (ANTICIPATED): June 1, 2025
• Study Completion (ANTICIPATED): June 1, 2025

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (ACTUAL): May 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: virtual reality mask; children from 7 to 13; allergic pricks tests; consultation and pediatric's day hospital
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endocrine System Diseases; Gonadal Disorders; Pain, Procedural; Testicular Diseases
• Other Study ID Numbers: GIRCI 2020 USCLADE; 2021-A02125-36 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No