Actively Recruiting

Phase Not Applicable
Age: 6Years - 16Years
All Genders
NCT06697275

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

Age: 6Years - 16Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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