Use of Virtual Reality in Pain Management in Pediatric Oncology

Not Applicable

Recruiting

• Conditions: Pediatric Tumor
• Interventions: Other: Virtual reality headset

• Registration Number: NCT05592132
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-30
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-24
• Study Start: 2023-01-17
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-10-02
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Virtual reality headset	Patients randomized in this arm will have the virtual reality headset associated to the standard care

Primary Outcome Measures

Name	Time	Method
Self pain evaluation	before blood sampling on catheter with implantable chamber	Pain will be assessed by the analogic visual scale (minimal score = 0 (no pain) , maximal score = 10 (maximal pain))

Trial Locations

Locations (1)

CHU de La Réunion; 🇷🇪 Saint-Denis, Réunion