This pilot study will be testing the feasibility of medical hypnosis through virtual reality during invasive médical procédures in children and young adults with cancer. Patients age from 7 to under 25 years whose treatement protocols required a lumbure puncture and a chemotherapy by implantable venous access will be randomly assigned to virtual reality or treatement as usual (nitrous oxide, anxiolytics, opioid analgesics, psychotropic and benzodiazepine). We expect the same benefit by using VR as usual intervention.
Patients aged 7 to strictly under 25
Follow-ups for hematological or oncological pathology
With a lumbar puncture or to connection to an implantable chamber
Patient understanding French
Children with cognitive impairment
Children in absolute emergency situations
Children with a contraindication to a virtual reality headset (psychiatric pathology, vestibular and proprioceptive disorders, unbalanced epilepsy, impaired vision, hearing aids, claustrophobia, recent lesions of the eyes, face or scalp)
Children who have already participated in the clinical investigation
Parallel
Virtual Reality
DeviceIn each arm, patients will benefit from an EMLA-type local anesthetic cream, pain and anxiety assessment. During the act, the physiological constants will be recorded (Fr, O2 and pulse). In the the RV group, The session will be started before the gesture and the patient will wear the helmet throughout the act. In case of pain and / or restlessness, the child will receive analgesics.
Usual Practices
DrugIn each arm, patients will benefit from an EMLA-type local anesthetic cream, pain and anxiety assessment. During the act, the physiological constants will be recorded (Fr, O2 and pulse). In the control group, the child will receive the usual care: nitrous oxide, anxiolytics, opioid analgesics, psychotropic and benzodiazepine
To assess the effectiveness of virtual reality compared to usual analgesic practices in pain management during the first lumbar puncture or connection to an implantable chamber of the study.
At the inclusion, the primary endpoint will be to assess pain using the Visual Analogue Scale (VAS) after the first invasive act of lumbar puncture or connection to an implantable chamber. The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The EVA (Analogue Visual Assessment) from 0 to 10, is a scale that can be used from the age of 7. It reliably allows self-assessment of pain. The scale will be explained to the child before the act and it will be presented to him after the invasive act for the assessment: * 0: no pain * Between 1 and 3: mild pain * Between 3 and 5: moderate-intensity pain * Between 5 and 7: severe pain * Greater than 7: very intense pain
Comparison, between the control group and the group supported with virtual reality: Pain from the VAS after the 1st connection to the implantable chamber
Pain from the VAS after the 1st connection to the implantable chamber: The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The VAS (Visual Analogue Assessment) from 0 to 10, is a scale that can be used from the age of 7. It reliably allows self-assessment of pain. The scale will be explained to the child before the act and it will be presented to him after the invasive act for the assessment: * 0: no pain * Between 1 and 3: mild pain * Between 3 and 5: moderate-intensity pain * Between 5 and 7: severe pain * Greater than 7: very intense pain
Comparison, between the control group and the group supported with virtual reality: Child's anxiety using the Frankl scale
The Frankl scale, is a scale of hetero-evaluation of anxiety. It will be performed by the caregiver before the invasive procedure (lumbar puncture and connection to an implantable chamber). It is suitable for children from 7 to under 25 years old and is easy to score: * 0: Definitely negative behavior; refuses treatment, shouts forcefully, opposes/cares, * 1: Negative behavior: unwilling to accept care; unwilling to accept care. Some signs of opposition exist but not necessarily declared (sullen air, scowling), * 2: Positive behaviour; accepts treatment with reservation. He is cautious but follows the instructions of the practitioner/caregiver * 3: Definitely positive behavior; good relations/practitioner/caregiver, interested in treatment. He laughs often and seems to enjoy the visit/care.
Comparison, between the control group and the group supported with virtual reality:The type and amount of analgesics consumed during the invasive act (lumbar puncture and / or connection to an implantable chamber)
The type of associated analgesics, the dosage will be collected through the patient's medical record
Comparison, between the control group and the group supported with virtual reality: Heart rate
Heart rate (min \<40 B/min - max \>200 B/min), from a scope connected to the patient before and throughout the duration of the invasive act (lumbar puncture and / or connection to an implantable chamber)
Click on the lead sponsor to view all of their trials.
