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

Plain Language Summary

Simplified for easier understanding

This study is testing whether using virtual reality (VR) can reduce pain and anxiety in children with leukemia when a needle is inserted into their implanted port (a device under the skin used to give medications). **You may be eligible if...** - Your child is between 6 and 16 years old and has leukemia - They need regular needle insertions into an implanted port - Their life expectancy is 3 months or more - Both the child and parents have given informed consent **You may NOT be eligible if...** - The child requires 100% oxygen breathing support - They have raised pressure in the skull (intracranial hypertension) - They have altered consciousness that would prevent them from using VR - There are contraindications to the inhaled pain relief used alongside VR (MEOPA) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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