Impact of Virtual Reality in Pediatric Hematology and Oncology

Study Overview
=================
Brief Summary
-----------------
This pilot study will be testing the feasibility of medical hypnosis through virtual reality during invasive médical procédures in children with cancer. Patients age from 7 to under 18 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.

Detailed Description
-----------------
Nationally, around 2,150 new cases of cancer are diagnosed per year in children aged 0 to 18. The main locations are leukemia, central system tumors and lymphomas. The onco-pediatrics unit of the Poitiers University Hospital is recruiting around 70 patients per year from 0 to under 18 years old. 1482 invasive procedures have been done in 2019. The diagnostic and therapeutic methods for these children remain aggressive and involve patients in chronic care. They repeatedly undergo painful and anxiety-inducing care. In pediatrics, nitrous oxide is chosen as the first-line choice in these various procedures, but its effectiveness is not always conclusive, due to habituation, and can induce side effects. For some children, it becomes difficult to obtain their consent to care, despite the range of different analgesics offered, and forces prescribers to increase the drugs. Virtual reality (VR) has already been shown to be effective on pain and anxiety in children and adolescents. This devices uses distraction and hypnosis techniques by establishing a state of hypnosedation and mediation through the work of breathing and sophrology. With this study, we expect the same benefit by using VR as usual pratices. After explaining the treatment protocol, the potentially eligible patient will be informed by the investigator of the possibility of participating in this clinical trial. After checking the eligibility criteria and including the patient, the investigator can randomize the patient in the control group or the experimental group. As part of this study, patients will be followed for 1 month and for each act of lumbar puncture and connection to an implantable chamber.

Official Title
-----------------
Impact of Virtual Reality in Pediatric Hematology and Oncology for the Management of Pain During Invasive Procedures in Children 7 to Under 18 Years in a Pilot Study

Conditions
-----------------
Virtual Reality, Pediatrics, Cancer, Pain, Procedural Pain

Intervention / Treatment
-----------------
* Device: Virtual Reality
* Drug: Usual Practices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 7 to strictly under 18 Follow-ups for hematological or oncological pathology With a lumbar puncture or to connection to an implantable chamber Patient understanding French Consent of parents or guardians with parental authority. Child informed and having given his assent Exclusion Criteria: 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 Refusal to participate in the study Patients not benefiting from a social security system or not benefiting from it by the intermediary of a third person

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is an exploratory interventional, comparative, single-center, randomized research into 2 parallel groups. The study will compare the use of virtual reality versus usual practices for two iterative and painful acts: lumbar puncture and connection to an implantable chamber.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality headset Group<br>30 patients will be included in the virtual reality arm | Device: Virtual Reality<br>* In 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.<br>|
| Active Comparator: Control group with usual practices<br>30 patients will be included the usual practices | Drug: Usual Practices<br>* In 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to one month | 
| 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 18 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. | up to one month | 
| 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 | up to one month | 
| 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) | up to one month | 
| Comparison, between the control group and the group supported with virtual reality:oxygen saturation | oxygen saturation (min <90% - max >100%) 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) | up to one month | 
| Comparison, between the control group and the group supported with virtual reality: Respiratory rate | Respiratory rate (min <10 - max > 50) 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) | up to one month | 
| Comparison, between the control group and the group supported with virtual reality: Tolerance | Tolerance, in number of episodes of confusion, agitation, dizziness, nausea, vomiting, headache, hallucinations and temporary amnesia during the performance of the invasive act and within 2 hours of post-act monitoring for a lumbar puncture and 30 minutes for a connection to an implantable chamber | up to one month | 
| Comparison, between the control group and the group supported with virtual reality: Pain after each act from the VAS | A patient may have several consecutive invasive acts. 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: 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 | up to one month | 
| Comparison, between the control group and the group supported with virtual reality: Pain from the VAS after the 1st connection to an implantable chamber | Pain from the VAS after the 1st connection to an implantable chamber the : 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 | up to one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual Reality, Pediatrics, Cancerology, Pain, Invasive Acts