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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: Virtual reality mask
* Other: control arm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled, open-label, two arms parallel, multicenter therapeutic trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard<br>Use local anesthesic cream + nurse or parents distraction +/- anesthesic or anxiolytic gas | Other: control arm<br>* usual process<br>|
| Experimental: virtual reality<br>Use local anesthesic cream and virtual reality mask | Device: Virtual reality mask<br>* virtual reality mask Deepsen® with age-appropriate software Birdy®<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality mask, children from 7 to 13, allergic pricks tests, consultation and pediatric's day hospital