Use of Virtual Reality in Pain Management in Pediatric Oncology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-17

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pediatric Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

intervention plus standard care versus standard care

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Virtual reality headset

Intervention Type OTHER

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.

Standard care

patients randomized in this arm will have standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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