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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Bordeaux
RECRUITING
Bordeaux
CHU de Clermont-Ferrand
RECRUITING
Clermont-ferrand
Assistance Publique - Hôpitaux de Marseille
RECRUITING
Marseille
CHU de Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Lise LACLAUTRE
promo_interne_drci@chu-clermontferrand.fr
+33473754963
Time Frame
Start Date: 2024-11-15
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 120
Treatments
Active_comparator: 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
Active_comparator: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Clermont-Ferrand

This content was sourced from clinicaltrials.gov