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

NCT06697275 | Recruiting

• 2 other identifiers: PHRIP-2022-USCLADE2023-A02154-41
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

acute leukemia; virtual reality mask; children and adolescents from 6 to 16

Outcome Measures

Primary Outcomes (1)

• Children's pain self-evaluation

  Self-evaluation of children's pain with the visual analog scale in vertical position. Quote from 0 to 10 with 10 being the worst score.

  15 minutes after the care

Secondary Outcomes (3)

• Children's fear evaluation

  15 minutes before the care and right after the procedure

• Children's heart rate measurement

  15 minutes before the care and right after the procedure

• Evaluation of the care

  After each care from the date of randomization and assessed during 3 months

Study Arms (3)

Standard method

ACTIVE COMPARATOR

In this standard method, before the treatment, the procedure of inserting the needle into the implantable port is explained to the child. The patient is comfortably installed and the treatment start using the standard method which consist on distracting the patient by singing, story telling, talking etc.. Use of local anesthesic cream and +/- anxiolytic gas

Other: Standard method

Interactive virtual reality

ACTIVE COMPARATOR

Before the treatment, the caregiver explains the procedure of inserting the needle into the implantable port. A general explanation is given on the VR device (how the headphones and headsets are placed), presentation of the virtual worlds to choose from, description of the course of the session (virtual travel is guided by a voice). For the interactive virtual reality, the mode of operation will be explained as the actions are validated using the eyes. The patient is then installed comfortably. The caregiver helps the child to put on the headphones and headset correctly. Before starting the care procedure, the caregiver will wait about 5 minutes after the start of the viewing to make sure the child is completely immersed in the virtual reality. The software is turned off about 3 minutes after the end of the care procedure. Use of local anesthesic cream.

Device: Interactive virtual reality

Hypnotic virtual reality

ACTIVE COMPARATOR

Before the treatment, the caregiver explains the procedure of inserting the needle into the implantable port to the child. A general explanation is given on the VR device (how the headphones and headsets are placed), presentation of the virtual worlds to choose from, description of the course of the session (virtual travel is guided by a voice). The patient is then installed comfortably. The caregiver helps the child to put on the headphones and headset correctly. Before starting the care procedure, the caregiver will wait about 5 minutes after the start of the viewing to make sure the child is completely immersed in the virtual reality. The software is turned off about 3 minutes after the end of the care procedure. Use of local anesthesic cream.

Device: Hypnotic Virtual reality

Interventions

Hypnotic Virtual reality DEVICE

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

Hypnotic virtual reality

Standard method OTHER

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

Standard method

Interactive virtual reality DEVICE

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

Interactive virtual reality

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children from 6 to 16 years old suffering from leukemia requiring needle insertion into an implantable port and having a life expectancy greater than or equal to 3 months
• Subjects and their parents who have been informed of the study and having expressed their informed consent
• Children without contraindications to the use of MEOPA® :
• Patient requiring 100% oxygen ventilation
• Intracranial hypertension
• Any alteration in the state of consciousness preventing the patient\'s cooperation
• Children without contraindication to the use of the virtual reality mask:
• Epilepsy
• Psychiatric illness
• Children and parents able to use the self-assessment scales proposed in the study
• Enrolment in the Social Security system

You may not qualify if:

• Children from 6 to 16:
• Having a modification of pain\'s integration (spina bifida for example)
• Requiring contact isolation (conjunctivitis, contagious skin condition, etc.)
• With a history of seizures

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (4)

CHU de Bordeaux

Bordeaux, 33000, France

RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Assistance Publique - Hôpitaux de Marseille

Marseille, 13005, France

RECRUITING

CHU de Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Alexandra USCLADE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, open-label, three arms parallel, multicenter therapeutic trial

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)