Use of Virtual Reality to Reduce Morphine Consumption in Adolescents Undergoing Scoliosis Surgery

Study Overview
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Brief Summary
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The objective is to evaluate the effect of the association of virtual reality sessions with usual management on the cumulative consumption of morphine equivalent post-operatively in adolescents aged 13 to 18 years who have undergone scoliosis surgery.

Official Title
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Use of Virtual Reality to Reduce Morphine Consumption in Adolescents Undergoing Scoliosis Surgery: A Prospective Randomized Open-label Study. Virtual Reality for Analgesia in Spine Surgery

Conditions
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Scoliosis

Intervention / Treatment
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* Device: Virtual Reality (VR) technique
* Drug: Analgesic protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient between 13 and 18 years old, i.e. the age to use a virtual reality helmet according to the manufacturer's recommendations. Patient with an indication for idiopathic scoliosis surgery. Free, informed and signed consent by patients (or parents/parental guardians) and the investigator (no later than the day of inclusion and prior to any review required by the research) Exclusion Criteria: Patient undergoing surgery for neurological scoliosis. Impossibility to use the VR helmet (blindness, eye infection, helmet wound, epilepsy, psychiatric or cognitive disorder incompatible with VR). History of adverse effects while wearing an VR helmet (nausea, vomiting, headache, visual disturbances) Patient with a contraindication to the use of morphinics Patient whose both parents benefit from a legal protection measure (guardianship, curatorship, safeguard of justice)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality group<br>Adolescents aged 13 to 18 years who have undergone scoliosis surgery | Device: Virtual Reality (VR) technique<br>* The PICO G2 4k helmet from the Chinese manufacturer Pico which is an autonomous virtual reality helmet will be used. The sessions proposed last 20 minutes with a child pain protocol. The teenager will be able to choose his universe (forest, beach, mountain, aquatic, space), the voice that accompanies him (man, woman, none), the sound environment of music therapy (6 to choose from). Each patient in the experimental group benefits from a virtual reality program including two daily sessions during their stay in the continuing care unit from the first post-operative day until the third post-operative day. Each session is proposed by a nurse anesthetist from the pain team and trained in the proper use of the equipment.This virtual reality program will be added to the standard analgesic protocol for the experimental group.<br>Drug: Analgesic protocol<br>* Patients randomized in the control group receive the usual analgesic protocol of the department postoperatively.<br>|
| Active Comparator: Control group<br>Adolescents aged 13 to 18 years who have undergone scoliosis surgery | Drug: Analgesic protocol<br>* Patients randomized in the control group receive the usual analgesic protocol of the department postoperatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative amount of morphine (mg) consumed for each participant. |  | From day 1 to day 3 postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain assessed on a scale of 1 to 10. | The patient will assess his pain on a scale ranging from 1 to 10, 1 being a very low pain to 10 very strong pain. | At day 3 postoperatively | 
| Maximum level of pain assessed on a scale of 1 to 10 | The patient will assess his pain on a scale ranging from 1 to 10, 1 being a very low pain to 10 very strong pain. | From day 1 to day 6 postoperatively | 
| Morphine-related side effects | Number and nature of morphine-related side effects | Between day 1 and day 3 postoperatively | 
| Treatment prescribed to combat the side effects of morphine | Nature of treatment | Between day 1 and day 3 postoperatively | 
| Dose of treatment prescribed to combat the side effects of morphine | Dose in mg | Between day 1 and day 3 postoperatively | 
| Duration of treatment prescribed to combat the side effects of morphine | Number of days | Between day 1 and day 3 postoperatively | 
| daily dose of morphine | daily dose of morphine equivalent in milligrams (mg) then related to the weight in milligrams per kilogram (mg/kg) | From day 1 to day 6 postoperatively | 
| Cost-effectiveness ratio | Calculated by taking into account the costs collected from the point of view of health insurance and the number of patients having avoided side effects at 6 days | From day 1 to day 6 postoperatively | 
| Side effects related to the use of the virtual reality | Number of side effects | From day 1 to day 3 postoperatively | 
| Number of drug treatments as well as the purchase price of RV from a hospital perspective |  | From day 1 to day 6 postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality, Scoliosis surgery, Adolescents, Pain management