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Trial Title:
Use of Virtual Reality in Pain Management in Pediatric Oncology
NCT ID:
NCT05592132
Condition:
Pediatric Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
intervention plus standard care versus standard care
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Virtual reality headset
Description:
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.
Arm group label:
Intervention
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.
Criteria for 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
Gender:
All
Minimum age:
6 Years
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de La Réunion
Address:
City:
Saint-Denis
Zip:
97400
Country:
Réunion
Status:
Recruiting
Contact:
Last name:
Yves REGUERRE, MD
Investigator:
Last name:
Yves REGUERRE, MD
Email:
Principal Investigator
Start date:
January 17, 2023
Completion date:
October 2025
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de la Réunion
Agency class:
Other
Source:
Centre Hospitalier Universitaire de la Réunion
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05592132
