Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia
Recruiting now · Not applicable
Conditions studied: Virtual Reality, Children and Adolescents, Acute Leukemia, Anxiety and Fear
In brief
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.
Key facts
- Study ID
- NCT06697275
- Run by
- University Hospital, Clermont-Ferrand
- People needed
- 120
- Starts
- 2024-11-15
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2025-12-04
Who can join
Age: 6 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- CHU de Bordeaux — Bordeaux, France (enrolling)
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (enrolling)
- Assistance Publique - Hôpitaux de Marseille — Marseille, France (enrolling)
- CHU de Toulouse — Toulouse, France (enrolling)
Full record on ClinicalTrials.gov
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