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

NCT ID: NCT06697275

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2027-10-01

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.

Detailed Description

Children and adolescents with acute leukemia frequently have anxiety-provoking and painful care in the management of their disease. As soon as the diagnosis is announced, the installation of a central line is recommended to allow the administration of chemotherapy treatments, parenteral nutrition, and blood tests. The implantable port (IP) is more often used than the central catheter. It allows the injection of drugs directly into the implantable port, through the skin using a specific needle whose caliber can be variable. This treatment, which can be repeated weekly, causes pain and anxiety for children. The use of skin anesthetic patches (EMLA®) is recommended to limit pain during needle installation. According to the literature, this system limits the pain associated with needle injections but does not reduce children's anxiety about this upcoming treatment. The repetition of the gesture, often for several months, is a source of discomfort and pain that only increases over time. A memorization of pain increases the apprehension of care by the child, his parents and can also create difficult care conditions for the caregiver. These children receive multiple treatments, which is why a non-drug intervention is recommended for the management of pain and anxiety. Standard distraction (e.g.: speech) is recommended but it is often insufficient. This is why the use of interactive or hypnotic virtual reality (VR) could improve the care of these children and in particular reduce anxiety and fear. The immersion of the child in a three-dimensional environment with sound and visual stimulation potentiates the diversion of his attention. Thus, it seems necessary to evaluate the impact of interactive or hypnotic virtual reality on pain and anxiety during repeated painful care in children with acute leukemia.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard method

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

Group Type: ACTIVE_COMPARATOR

Standard method

Intervention Type: OTHER

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

Interactive virtual reality

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.

Group Type: ACTIVE_COMPARATOR

Interactive virtual reality

Intervention Type: DEVICE

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

Hypnotic virtual reality

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.

Group Type: ACTIVE_COMPARATOR

Hypnotic Virtual reality

Intervention Type: DEVICE

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

Interventions

Hypnotic Virtual reality

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

Intervention Type: DEVICE

Interactive virtual reality

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

Intervention Type: DEVICE

Standard method

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandra USCLADE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Bordeaux

Bordeaux, , France

Site Status: RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Assistance Publique - Hôpitaux de Marseille

Marseille, , France

Site Status: RECRUITING

CHU de Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lise LACLAUTRE

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Facility Contacts

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Other Identifiers

2023-A02154-41

Identifier Type: OTHER

Identifier Source: secondary_id

PHRIP-2022-USCLADE

Identifier Type: -

Identifier Source: org_study_id