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

NCT04892940 | Completed

• 1 other identifier: RC31/20/0447
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis

Keywords

Virtual reality; Scoliosis surgery; Adolescents; Pain management

Outcome Measures

Primary Outcomes (1)

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

  From day 1 to day 3 postoperatively

Secondary Outcomes (10)

• Intensity of pain assessed on a scale of 1 to 10.

  At day 3 postoperatively

• Maximum level of pain assessed on a scale of 1 to 10

  From day 1 to day 6 postoperatively

• Morphine-related side effects

  Between day 1 and day 3 postoperatively

• Treatment prescribed to combat the side effects of morphine

  Between day 1 and day 3 postoperatively

• Dose of treatment prescribed to combat the side effects of morphine

  Between day 1 and day 3 postoperatively

Study Arms (2)

Virtual Reality group

EXPERIMENTAL

Adolescents aged 13 to 18 years who have undergone scoliosis surgery

Device: Virtual Reality (VR) technique; Drug: Analgesic protocol

Control group

ACTIVE COMPARATOR

Adolescents aged 13 to 18 years who have undergone scoliosis surgery

Drug: Analgesic protocol

Interventions

Virtual Reality (VR) technique DEVICE

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.

Virtual Reality group

Analgesic protocol DRUG

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

Control group; Virtual Reality group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Scoliosis; Agnosia

Interventions

Methods

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Servane LE GOAS UGUEN

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: May 19, 2021
• Study Start: February 21, 2022
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)