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RECRUITING
NCT06697275
NA

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

View on ClinicalTrials.gov

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

DEVICE

Hypnotic Virtual reality

Hypnotic Virtual reality mask Deepsen® with age-appropriate software Birdy®

DEVICE

Interactive virtual reality

Interactive virtual reality mask Deepsen® with age-appropriate software Birdy®

OTHER

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