NCT06697275 Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia
| NCT ID | NCT06697275 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Virtual Reality |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2027-10-01 |
Trial Parameters
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Brief 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 Criteria
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