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

Toulouse University Hospital

Status: Completed

Conditions: Scoliosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04892940

RC31/20/0447

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Virtual Reality group

Experimental group

Description:

Adolescents aged 13 to 18 years who have undergone scoliosis surgery

Treatment:

Drug: Analgesic protocol

Device: Virtual Reality (VR) technique

Control group

Active Comparator group

Description:

Adolescents aged 13 to 18 years who have undergone scoliosis surgery

Treatment:

Drug: Analgesic protocol