Clinical trial NCT04892940: Use of Virtual Reality to Reduce Morphine Consumption in Adolescents Undergoing Scoliosis Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis
Keywords: Virtual reality
Scoliosis surgery
Adolescents
Pain management
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 101
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Cumulative amount of morphine (mg) consumed for each participant.
timeFrame: From day 1 to day 3 postoperatively
Secondary outcomes:
measure: Intensity of pain assessed on a scale of 1 to 10.
timeFrame: At day 3 postoperatively
measure: Maximum level of pain assessed on a scale of 1 to 10
timeFrame: From day 1 to day 6 postoperatively
measure: Morphine-related side effects
timeFrame: Between day 1 and day 3 postoperatively
measure: Treatment prescribed to combat the side effects of morphine
timeFrame: Between day 1 and day 3 postoperatively
measure: Dose of treatment prescribed to combat the side effects of morphine
timeFrame: Between day 1 and day 3 postoperatively
measure: Duration of treatment prescribed to combat the side effects of morphine
timeFrame: Between day 1 and day 3 postoperatively
measure: daily dose of morphine
timeFrame: From day 1 to day 6 postoperatively
measure: Cost-effectiveness ratio
timeFrame: From day 1 to day 6 postoperatively
measure: Side effects related to the use of the virtual reality
timeFrame: From day 1 to day 3 postoperatively
measure: Number of drug treatments as well as the purchase price of RV from a hospital perspective
timeFrame: From day 1 to day 6 postoperatively
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Servane LE GOAS UGUEN
role: PRINCIPAL_INVESTIGATOR
References: