Actively Recruiting
Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia
Led by University Hospital, Clermont-Ferrand · Updated on 2025-12-04
120
Participants Needed
4
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to 16 years with leukemia requiring needle insertion into an implantable port and life expectancy of at least 3 months
- Informed consent given by the child and their parents after being informed about the study
- Children without contraindications to MEOPA® such as the need for 100% oxygen ventilation, intracranial hypertension, or altered consciousness preventing cooperation
- Children without contraindications to virtual reality mask use, including epilepsy and psychiatric illness
- Children and parents able to use the self-assessment scales required in the study
- Enrollment in the Social Security system
You will not qualify if you...
- Children with altered pain perception (e.g., spina bifida)
- Children requiring contact isolation due to contagious conditions
- Children with a history of seizures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
CHU de Bordeaux
Bordeaux, France, 33000
Actively Recruiting
2
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
Actively Recruiting
3
Assistance Publique - Hôpitaux de Marseille
Marseille, France, 13005
Actively Recruiting
4
CHU de Toulouse
Toulouse, France, 31059
Actively Recruiting
Research Team
L
Lise LACLAUTRE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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