Use of Virtual Reality in Pain Management in Pediatric Oncology
DOREVI
1 other identifier
interventional
74
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2022
CompletedFirst Posted
Study publicly available on registry
October 24, 2022
CompletedStudy Start
First participant enrolled
January 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedMarch 13, 2026
March 1, 2026
3.3 years
June 30, 2022
March 11, 2026
Conditions
Outcome Measures
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))
before blood sampling on catheter with implantable chamber
Study Arms (2)
Intervention
EXPERIMENTALPatients randomized in this arm will have the virtual reality headset associated to the standard care
Standard care
NO INTERVENTIONpatients randomized in this arm will have standard care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- patient with visual or hearing impairement
- patient with epilepsy or other neurological disease
- patient with psychiatric disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de La Réunion
Saint-Denis, 97400, Reunion
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Yves REGUERRE
CHU de La Réunion
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2022
First Posted
October 24, 2022
Study Start
January 17, 2023
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
March 13, 2026
Record last verified: 2026-03