Use of Virtual Reality to Reduce Morphine Consumption in Adolescents Undergoing Scoliosis Surgery
- Conditions
- Scoliosis
- Interventions
- Device: Virtual Reality (VR) techniqueDrug: Analgesic protocol
- Registration Number
- NCT04892940
- Lead Sponsor
- University Hospital, Toulouse
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual Reality group Virtual Reality (VR) technique Adolescents aged 13 to 18 years who have undergone scoliosis surgery Virtual Reality group Analgesic protocol Adolescents aged 13 to 18 years who have undergone scoliosis surgery Control group Analgesic protocol Adolescents aged 13 to 18 years who have undergone scoliosis surgery
- Primary Outcome Measures
Name Time Method Cumulative amount of morphine (mg) consumed for each participant. From day 1 to day 3 postoperatively
- Secondary Outcome Measures
Name Time Method 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
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.
Treatment prescribed to combat the side effects of morphine Between day 1 and day 3 postoperatively Nature of treatment
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)
Morphine-related side effects Between day 1 and day 3 postoperatively Number and nature of morphine-related side effects
Dose of treatment prescribed to combat the side effects of morphine Between day 1 and day 3 postoperatively Dose in mg
Duration of treatment prescribed to combat the side effects of morphine Between day 1 and day 3 postoperatively Number of days
Number of drug treatments as well as the purchase price of RV from a hospital perspective From day 1 to day 6 postoperatively 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.
Side effects related to the use of the virtual reality From day 1 to day 3 postoperatively Number of side effects
Trial Locations
- Locations (1)
CHU Toulouse
🇫🇷Toulouse, France