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

NCT ID: NCT04892940

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-21
• Study Completion Date: 2024-07-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Reality group

Adolescents aged 13 to 18 years who have undergone scoliosis surgery

Group Type: EXPERIMENTAL

Virtual Reality (VR) technique

Intervention Type: 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.

Analgesic protocol

Intervention Type: DRUG

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

Control group

Adolescents aged 13 to 18 years who have undergone scoliosis surgery

Group Type: ACTIVE_COMPARATOR

Analgesic protocol

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DEVICE

Analgesic protocol

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Servane LE GOAS UGUEN

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU Toulouse

Toulouse, , France

Countries

France

Other Identifiers

RC31/20/0447

Identifier Type: -

Identifier Source: org_study_id