Pediatric TumorDOREVINCT05592132
Use of Virtual Reality in Pain Management in Pediatric Oncology
A study testing Virtual reality headset in people with Pediatric Tumor, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Pediatric Tumor
- What is being tested?
- Virtual reality headset
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteReunion
- Study dates
- 17 Jan 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- patient with visual or hearing impairement
- patient with epilepsy or other neurological disease
- patient with psychiatric disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Reunion1 site, 1 recruiting
- Recruiting
CHU de La Réunion
Saint-Denis, 97400
Yves REGUERRE, MD
Yves REGUERRE, MD
About this study
Official title: Use of Virtual Reality in Pain Management During Invasive Gestures in Pediatric Oncology: Randomized Controlled Trial
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.
- Conditions
- Pediatric Tumor
- Being tested
- Virtual reality headset
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headsetOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients randomized in this arm will have the virtual reality headset associated to the standard care Receives: Other: Virtual reality headset |
| Standard care | No intervention | patients randomized in this arm will have standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self pain evaluation
Pain will be assessed by the analogic visual scale (minimal score = 0 (no pain) , maximal score = 10 (maximal pain))
Measured: before blood sampling on catheter with implantable chamber
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start17 Jan 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention plus standard care versus standard care
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves REGUERRE, Principal investigator, CHU de La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592132
- Sponsor's protocol ID
- 2022/CHU/11
- Acronym
- DOREVI
- Status last verified
- Mar 2026
- First submitted
- 30 Jun 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality in Pain Management During Invasive Gestures in Pediatric Oncology: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05592132
- Acronym / sponsor ID
- DOREVI / 2022/CHU/11
- Conditions
- Pediatric Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention plus standard care versus standard care
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Virtual reality headsetPatients randomized in this arm will have the virtual reality headset associated to the standard care |
| Standard care | No intervention | –patients randomized in this arm will have standard care. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- patient with visual or hearing impairement
- patient with epilepsy or other neurological disease
- patient with psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality headsetEach 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. | Other | Intervention |
Primary outcome
Self pain evaluation
Time frame: 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))
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yves REGUERRE principal investigator
CHU de La Réunion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality headset in people with Pediatric Tumor, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yves REGUERRE (+262262905676, yves.reguerre@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self pain evaluation (time frame: before blood sampling on catheter with implantable chamber). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.