Use of Virtual Reality in Pain Management in Pediatric Oncology
ConditionPediatric Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorCentre Hospitalier Universitaire de la Réunion
About this trial
DOREVI is a monocentric randomized controlled study that will evaluate the efficacy of virtual reality helmets for pain prevention during invasive care on 78 oncologic pediatric patients. Two groups of children (between 6 and 11 and between 12 and 18 years old) will be randomized to use helmet plus standard care or standard care alone during invasive procedures (central venous catheter puncture, lumbar puncture, or bone marrow aspiration). The pain intensity will be evaluated using a visual analogic scale during three invasive procedures, and results will be compared between the patients with or without virtual reality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patient who tolerates the virtual reality headset
patient followed in pediatric oncology
patient with a diagnosis of benign tumor or cancer
patient who needs to have painful medical procedure during their treatment
Disqualifiers
patient with visual or hearing impairement
patient with epilepsy or other neurological disease
patient with psychiatric disease
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual reality headset
Other interventionEach patient in this treatment group will use a virtual reality headset during 3 procedures. During each procedure, the pain level will be assessed and compared with the assessed group.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Self pain evaluation
Pain will be assessed by the analogic visual scale (minimal score = 0 (no pain) , maximal score = 10 (maximal pain))
Time frame
before blood sampling on catheter with implantable chamberSponsors and contacts
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Source ClinicalTrials.gov