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

What this Trial Is About

Children and adolescents aged 6 to 16 years with acute leukemia often experience painful and anxiety-inducing treatments, especially during needle insertions into implantable ports used for administering chemotherapy and other therapies. This trial evaluates whether repeated use over three months of interactive or hypnotic virtual reality (VR) can better manage pain and reduce anxiety for the child, their parents, and caregivers compared to the standard distraction methods during these procedures. Participants are randomly assigned to one of three groups: the standard method involving local anesthetic cream and distraction by caregivers or parents, interactive virtual reality using a VR mask with guided virtual environments, or hypnotic virtual reality using a similar mask but with hypnotic software. In both VR groups, the child wears headphones and a headset and is immersed in a virtual world starting about five minutes before the needle insertion and continuing briefly after the procedure, with local anesthetic cream applied in all groups. During the study, children and their parents will be assessed for pain and anxiety using self-evaluation scales, heart rate monitoring, and satisfaction questionnaires after each needle insertion over a three-month period. Pain is primarily measured 15 minutes after the procedure. Researchers will also monitor fear levels and heart rate before and immediately after care to understand the impact of VR on the experience. The total participation spans these repeated care sessions during the three months following randomization.

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