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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-16
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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

Qualifiers

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

Patient requiring 100% oxygen ventilation

Intracranial hypertension

Disqualifiers

Having a modification of pain's integration (spina bifida for example)

Requiring contact isolation (conjunctivitis, contagious skin condition, etc.)

With a history of seizures

Trial design

Treatments tested in this trial

  • Hypnotic Virtual reality
  • Interactive virtual reality
  • Standard method

Treatment groups

120 Participants
are divided into 3 treatment groups