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

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

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 Overview

• Status: Completed
• Conditions: Scoliosis
• Intervention / Treatment: Device: Virtual Reality (VR) technique; Drug: Analgesic protocol

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • Chu Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality group; Adolescents aged 13 to 18 years who have undergone scoliosis surgery	Device: Virtual 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.; Drug: Analgesic protocol; Patients randomized in the "control" group receive the usual analgesic protocol of the department postoperatively.
Active Comparator: Control group; Adolescents aged 13 to 18 years who have undergone scoliosis surgery	Drug: Analgesic protocol; Patients randomized in the "control" group receive the usual analgesic protocol of the department postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Servane LE GOAS UGUEN, Chu Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2022
• Primary Completion (Actual): July 24, 2024
• Study Completion (Actual): July 24, 2024

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Adolescents; Pain management; Virtual reality; Scoliosis surgery
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: RC31/20/0447

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No