Clinical trial NCT06697275: Evaluation of the Efficacy of a Virtual Reality When Placing a Needle on an Implantable Venous Access Device in Children with Leukemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Virtual Reality
Children and Adolescents
Acute Leukemia
Anxiety and Fear
Keywords: acute leukemia
virtual reality mask
children and adolescents from 6 to 16
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, open-label, three arms parallel, multicenter therapeutic trial
Primary purpose: SUPPORTIVE_CARE

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\&#39;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\&amp;amp;#39;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.

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\&#39;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\&#39;s integration (spina bifida for example)
* Requiring contact isolation (conjunctivitis, contagious skin condition, etc.)
* With a history of seizures

Primary outcomes:
measure: Children&#39;s pain self-evaluation
timeFrame: 15 minutes after the care
Secondary outcomes:
measure: Children&#39;s fear evaluation
timeFrame: 15 min before and right after the procedure
measure: Children&#39;s heart rate measurement
timeFrame: 15 min before and right after the procedure
measure: Evaluation of the care
timeFrame: 4 and 12 weeks post-inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Marseille
country: France
facility: Assistance Publique - Hôpitaux de Marseille
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Alexandra USCLADE
role: PRINCIPAL_INVESTIGATOR
References: