Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Children's pain self-evaluation — 15 minutes after the care
  Self-evaluation of children's pain with the visual analog scale in vertical position. Quote from 0 to 10 with 10 being the worst score.

Trial sites (4)

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