Skip to main content
OpenTrials
Completed

NCT Number: NCT05378581

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand, Clermont-Ferrand, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality mask

Device

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

Control Arm

Other

usual process

Primary outcomes

  1. children's pain hetero-evaluation

    Time frame: during blood test

    children's pain evaluation by the nurse with the visual analog scale quote from 0 to 10, 10=worst score

  2. children's pain hetero-evaluation

    Time frame: during procedure (prick test)

    children's pain evaluation by the nurse with the visual analog scale from 0 to 10, 10= worst score

  3. children's pain self-evaluation

    Time frame: 5 min after the care

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

Secondary outcomes

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

    Time frame: before the care and 5 min after the care

    self-evaluation of children's anxiety with the scale "child fear scale" quote from 0 to 4, 4= worst score

  2. children's anxiety hetero evaluation

    Time frame: during blood test

    children's anxiety evaluation by the nurse with the scale "child fear scale" quote from 0 to 4, 4= worst score

  3. children's anxiety hetero evaluation

    Time frame: during procedure (prick tests)

    children's anxiety evaluation by the nurse with the scale "child fear scale" quote from 0 to 4, 4= worst score

  4. change from baseline parents' anxiety at just after the care

    Time frame: before the care and 5 min after the care

    self-evaluation of parents' anxiety with the numerical scale quote from 1 to 10, 10= worst score

  5. evaluation of the care

    Time frame: 5 min after 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study 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

Acronym: REVAPRICK

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 18, 2022
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.