Scoliosis
Conditions
Keywords
Virtual reality, Scoliosis surgery, Adolescents, Pain management
Brief summary
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.
Interventions
DEVICEVirtual Reality (VR) technique
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.
DRUGAnalgesic protocol
Patients randomized in the control group receive the usual analgesic protocol of the department postoperatively.
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative amount of morphine (mg) consumed for each participant. | From day 1 to day 3 postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of pain assessed on a scale of 1 to 10. | At day 3 postoperatively | 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. |
| Maximum level of pain assessed on a scale of 1 to 10 | From day 1 to day 6 postoperatively | 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. |
| Morphine-related side effects | Between day 1 and day 3 postoperatively | Number and nature of morphine-related side effects |
| Treatment prescribed to combat the side effects of morphine | Between day 1 and day 3 postoperatively | Nature of treatment |
| Side effects related to the use of the virtual reality | From day 1 to day 3 postoperatively | Number of side effects |
| Duration of treatment prescribed to combat the side effects of morphine | Between day 1 and day 3 postoperatively | Number of days |
| daily dose of morphine | From day 1 to day 6 postoperatively | daily dose of morphine equivalent in milligrams (mg) then related to the weight in milligrams per kilogram (mg/kg) |
| Cost-effectiveness ratio | From day 1 to day 6 postoperatively | 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 |
| Number of drug treatments as well as the purchase price of RV from a hospital perspective | From day 1 to day 6 postoperatively | — |
| Dose of treatment prescribed to combat the side effects of morphine | Between day 1 and day 3 postoperatively | Dose in mg |
Countries
France
Outcome results
None listed