Use of Virtual Reality in Pain Management in Pediatric Oncology

Pediatric Tumor Clinical Trial

— DOREVI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05592132
• Other study ID #: 2022/CHU/11
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: October 2025

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Yves REGUERRE
• Phone: +262262905676
• Email: yves.reguerre[@]chu-reunion.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Pediatric Tumor

Intervention

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.

Locations

Country	Name	City	State
Réunion	CHU de La Réunion	Saint-Denis

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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