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

University Hospital, Toulouse101 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

101

Conditions

Scoliosis

Interventions

Virtual Reality (VR) techniqueDEVICE

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.

Analgesic protocolDRUG

Patients randomized in the "control" group receive the usual analgesic protocol of the department postoperatively.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

CHU Toulouse

Toulouse, France

Outcomes

Primary Outcomes

Cumulative amount of morphine (mg) consumed for each participant.

Time frame: From day 1 to day 3 postoperatively

Secondary Outcomes

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.

Time frame: 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.

Time frame: From day 1 to day 6 postoperatively

Morphine-related side effects

Number and nature of morphine-related side effects

Time frame: Between day 1 and day 3 postoperatively

Treatment prescribed to combat the side effects of morphine

Nature of treatment

Time frame: Between day 1 and day 3 postoperatively

Dose of treatment prescribed to combat the side effects of morphine

Dose in mg

Time frame: Between day 1 and day 3 postoperatively

Duration of treatment prescribed to combat the side effects of morphine

Number of days

Time frame: 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)

Data from ClinicalTrials.gov

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