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

Virtual Reality Clinical Trial

— REVAPRICK  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05378581
• Other study ID #: GIRCI 2020 USCLADE
• Secondary ID: 2021-A02125-36
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: June 2025

Study information

• Verified date: March 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety and Fear
• Children, Only
• Pain, Procedural
• Testicular Diseases
• Virtual Reality

Intervention

Device:
• Virtual reality mask
virtual reality mask Deepsen® with age-appropriate software Birdy®

Other:
• control arm
usual process

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	CHU de Saint Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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