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Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia
Sponsor: University Hospital, Clermont-Ferrand
Summary
Main objective: Evaluate the effectiveness of the repeated use of interactive or hypnotic virtual reality compared to standard treatment, on pain, during each needle placement on PAC for 3 months on children or adolescents (6 to 16 years old) with acute leukemia Hypothesis: Repeated use over 3 months of hypnotic or interactive virtual reality provides more benefits in terms of : * pain management * anxiety of the child and his parents * satisfaction of the child's care, of his parents and of the caregivers compared to the standard method when inserting a needle into an implantable port in the pediatric oncology department or day hospital.
Official title: Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia: Randomized Multicenter Trial
Key Details
Gender
All
Age Range
6 Years - 16 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-11-15
Completion Date
2027-10-01
Last Updated
2025-12-04
Healthy Volunteers
No
Interventions
Hypnotic Virtual reality
Hypnotic Virtual reality mask Deepsen® with age-appropriate software Birdy®
Interactive virtual reality
Interactive virtual reality mask Deepsen® with age-appropriate software Birdy®
Standard method
Use of local anesthesic cream + Nurse and/or parents distraction +/- anxioloytic gas
Locations (4)
CHU de Bordeaux
Bordeaux, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Assistance Publique - Hôpitaux de Marseille
Marseille, France
CHU de Toulouse
Toulouse, France