NCT05592132

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 17, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

3.3 years

First QC Date

June 30, 2022

Last Update Submit

March 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Virtual reality headset

Standard care

NO INTERVENTION

patients randomized in this arm will have standard care.

Interventions

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

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • patient with visual or hearing impairement
  • patient with epilepsy or other neurological disease
  • patient with psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de La Réunion

Saint-Denis, 97400, Reunion

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Yves REGUERRE

    CHU de La Réunion

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: intervention plus standard care versus standard care
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2022

First Posted

October 24, 2022

Study Start

January 17, 2023

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations