Menu
Recruiting NCT05592132

Use of Virtual Reality in Pain Management in Pediatric Oncology

No phase Interventional Pediatric Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual reality headset.
Who it may be relevant to
Registry conditions: Pediatric Tumor. Basic parameters: 6 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Reunion
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Use of Virtual Reality in Pain Management During Invasive Gestures in Pediatric Oncology: Randomized Controlled Trial

Overview

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.

Interventions

  • Other Virtual reality headset
    Each 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.

Primary outcome measures

  • Self pain evaluation [Time frame: before blood sampling on catheter with implantable chamber]

Eligibility criteria

Inclusion criteria

  • 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
  • patient whose parents have signed the informed consent
  • patient affiliated with social security or equivalent

Exclusion criteria

  • patient with visual or hearing impairement
  • patient with epilepsy or other neurological disease
  • patient with psychiatric disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Reunion · 1 center
  • CHU de La Réunion — Saint-Denis

Identifiers

NCT: NCT05592132 · 2022/CHU/11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗