RecruitingNot ApplicableNCT06697275

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

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

Sponsor

University Hospital, Clermont-Ferrand

Enrollment

120 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Leukemia Virtual Reality Children and Adolescents Anxiety and Fear

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

Min Age: 6 YearsMax Age: 16 Years

Inclusion Criteria11

Children from 6 to 16 years old suffering from leukemia requiring needle insertion into an implantable port and having a life expectancy greater than or equal to 3 months
Subjects and their parents who have been informed of the study and having expressed their informed consent
Children without contraindications to the use of MEOPA® :
Patient requiring 100% oxygen ventilation
Intracranial hypertension
Any alteration in the state of consciousness preventing the patient\'s cooperation
Children without contraindication to the use of the virtual reality mask:
Epilepsy
Psychiatric illness
Children and parents able to use the self-assessment scales proposed in the study
Enrolment in the Social Security system