Health TrialsbyHealthPanel

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

ConditionsVirtual RealityChildren and AdolescentsAcute LeukemiaAnxiety and Fear
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Hypnotic Virtual reality

    Device

    Hypnotic Virtual reality mask Deepsen® with age-appropriate software Birdy®

  • Interactive virtual reality

    Device

    Interactive virtual reality mask Deepsen® with age-appropriate software Birdy®

  • Standard method

    Other intervention

    Use of local anesthesic cream + Nurse and/or parents distraction +/- anxioloytic gas

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Standard methodActive comparator 1 intervention
Group B: Interactive virtual realityActive comparator 1 intervention
Group C: Hypnotic virtual realityActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Children's pain self-evaluation

Self-evaluation of children's pain with the visual analog scale in vertical position. Quote from 0 to 10 with 10 being the worst score.

Time frame
15 minutes after the care

Secondary outcomes

1

Children's fear evaluation

Children's fear evaluation by the nurse with the visual analog scale from 0 to 10 with 10 being the worst score

Time frame
15 minutes before the care and right after the procedure
2

Children's heart rate measurement

Heart rate mesure using a digital sensor

Time frame
15 minutes before the care and right after the procedure
3

Evaluation of the care

Satisfaction of the care given to the child filled out by nurses, parents and child using a questionnaire. Score going fro 1 to 3 with 3 being the best score = very satisfied

Time frame
After each care from the date of randomization and assessed during 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Clermont-Ferrand

Lead sponsor

Source ClinicalTrials.gov
Apply now