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DOREVI: Use of Virtual Reality in Pain Management in Pediatric Oncology

Sponsor
Centre Hospitalier Universitaire de la Réunion (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05592132
Collaborator
(none)
74
Enrollment
2
Arms
28
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual reality headset
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
intervention plus standard care versus standard careintervention plus standard care versus standard care
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Use of Virtual Reality in Pain Management During Invasive Gestures in Pediatric Oncology: Randomized Controlled Trial
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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

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.
No Intervention: Standard care

patients randomized in this arm will have standard care.

Outcome Measures

Primary Outcome Measures

  1. Self pain evaluation [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))

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de la Réunion

Investigators

  • Principal Investigator: Yves REGUERRE, CHU de La Réunion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier:
NCT05592132
Other Study ID Numbers:
  • 2022/CHU/11
First Posted:
Oct 24, 2022
Last Update Posted:
Oct 24, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Oct 24, 2022