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Impact of Virtual Reality in Hematology and Oncology During Invasive Procedures in Children, Adolescents and Young Adults, from 7 to Less Than 25 Years Old

NCT05275881 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-16

No results posted yet for this study

Summary

This pilot study will be testing the feasibility of medical hypnosis through virtual reality during invasive médical procédures in children and young adults with cancer. Patients age from 7 to under 25 years whose treatement protocols required a lumbure puncture and a chemotherapy by implantable venous access will be randomly assigned to virtual reality or treatement as usual (nitrous oxide, anxiolytics, opioid analgesics, psychotropic and benzodiazepine). We expect the same benefit by using VR as usual intervention.

Conditions

  • Virtual Reality
  • Pediatrics
  • Cancer
  • Pain
  • Procedural Pain

Interventions

DEVICE

Virtual Reality

In each arm, patients will benefit from an EMLA-type local anesthetic cream, pain and anxiety assessment. During the act, the physiological constants will be recorded (Fr, O2 and pulse). In the the RV group, The session will be started before the gesture and the patient will wear the helmet throughout the act. In case of pain and / or restlessness, the child will receive analgesics.

DRUG

Usual Practices

In each arm, patients will benefit from an EMLA-type local anesthetic cream, pain and anxiety assessment. During the act, the physiological constants will be recorded (Fr, O2 and pulse). In the control group, the child will receive the usual care: nitrous oxide, anxiolytics, opioid analgesics, psychotropic and benzodiazepine

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Principal Investigators

  • Amandine AF FERNANDES · Poitiers University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-13
Primary Completion
2026-11-13
Completion
2026-12-13

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05275881 on ClinicalTrials.gov