Virtual Reality, Children and Adolescents, Acute Leukemia, Anxiety and Fear
Conditions
Keywords
acute leukemia, virtual reality mask, children and adolescents from 6 to 16
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.
Interventions
DEVICEHypnotic Virtual reality
Hypnotic Virtual reality mask Deepsen® with age-appropriate software Birdy®
Interactive virtual reality mask Deepsen® with age-appropriate software Birdy®
OTHERStandard method
Use of local anesthesic cream + Nurse and/or parents distraction +/- anxioloytic gas
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized, controlled, open-label, three arms parallel, multicenter therapeutic trial
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Children's pain self-evaluation | 15 minutes after the care | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Children's fear evaluation | 15 minutes before the care and right after the procedure | Children's fear evaluation by the nurse with the visual analog scale from 0 to 10 with 10 being the worst score |
| Children's heart rate measurement | 15 minutes before the care and right after the procedure | Heart rate mesure using a digital sensor |
| Evaluation of the care | After each care from the date of randomization and assessed during 3 months | Satisfaction of the care given to the child filled out by nurses, parents and child using a questionnaire. Score going fro 1 to 3 with 3 being the best score = very satisfied |
Countries
France
Contacts
Primary ContactLise LACLAUTRE
Outcome results
None listed