Use of Virtual Reality in Pain Management in Pediatric Oncology (DOREVI)

Centre Hospitalier Universitaire de la Réunion

Status: Enrolling

Conditions: Pediatric Tumor

Treatments: Other: Virtual reality headset

Study type: Interventional

Funder types: Other

Identifiers

NCT05592132

2022/CHU/11

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Intervention

Experimental group

Description:

Patients randomized in this arm will have the virtual reality headset associated to the standard care

Treatment:

Other: Virtual reality headset

Standard care

No Intervention group

Description:

patients randomized in this arm will have standard care.