Virtual Reality Clinical Trial
— REVAPRICKOfficial 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
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
Status | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Clermont-Ferrand | Clermont-Ferrand | |
France | CHU de Saint Etienne | Saint-Étienne |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
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 |
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