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Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children With Leukemia

NCT06697275 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-04

No results posted yet for this study

Summary

Main objective:

Evaluate the effectiveness of the repeated use of interactive or hypnotic virtual reality compared to standard treatment, on pain, during each needle placement on PAC for 3 months on children or adolescents (6 to 16 years old) with acute leukemia

Hypothesis:

Repeated use over 3 months of hypnotic or interactive virtual reality provides more benefits in terms of :

* pain management
* anxiety of the child and his parents
* satisfaction of the child's care, of his parents and of the caregivers compared to the standard method when inserting a needle into an implantable port in the pediatric oncology department or day hospital.

Conditions

  • Virtual Reality
  • Children and Adolescents
  • Acute Leukemia
  • Anxiety and Fear

Interventions

DEVICE

Hypnotic Virtual reality

Hypnotic Virtual reality mask Deepsen® with age-appropriate software Birdy®

DEVICE

Interactive virtual reality

Interactive virtual reality mask Deepsen® with age-appropriate software Birdy®

OTHER

Standard method

Use of local anesthesic cream + Nurse and/or parents distraction +/- anxioloytic gas

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Alexandra USCLADE · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2027-10-01
Completion
2027-10-01

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 NCT06697275 on ClinicalTrials.gov