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

RecruitingNAAges 6 Years - 16 YearsAllUniversity Hospital, Clermont-Ferrand
NCT06697275 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: Children from 6 to 16: * Having a modification of pain\'s integration (spina bifida for example) * Requiring contact isolation (conjunctivitis, contagious skin condition, etc.) * With a history of seizures
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What it tests

  • Hypnotic Virtual reality
  • Interactive virtual reality
  • Standard method
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Where

4 sites
CHU de Bordeaux
Bordeaux, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Assistance Publique - Hôpitaux de Marseille
Marseille, France
CHU de Toulouse
Toulouse, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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