Skip to main content
OpenTrials
Completed

NCT Number: NCT04892940

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Analgesic protocol

Drug

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

Primary outcomes

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

    Time frame: From day 1 to day 3 postoperatively

Secondary outcomes

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

    Time frame: At day 3 postoperatively

    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.

  2. Maximum level of pain assessed on a scale of 1 to 10

    Time frame: From day 1 to day 6 postoperatively

    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.

  3. Morphine-related side effects

    Time frame: Between day 1 and day 3 postoperatively

    Number and nature of morphine-related side effects

  4. Treatment prescribed to combat the side effects of morphine

    Time frame: Between day 1 and day 3 postoperatively

    Nature of treatment

  5. Dose of treatment prescribed to combat the side effects of morphine

    Time frame: Between day 1 and day 3 postoperatively

    Dose in mg

  6. Duration of treatment prescribed to combat the side effects of morphine

    Time frame: Between day 1 and day 3 postoperatively

    Number of days

  7. daily dose of morphine

    Time frame: From day 1 to day 6 postoperatively

    daily dose of morphine equivalent in milligrams (mg) then related to the weight in milligrams per kilogram (mg/kg)

  8. Cost-effectiveness ratio

    Time frame: From day 1 to day 6 postoperatively

    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

  9. Side effects related to the use of the virtual reality

    Time frame: From day 1 to day 3 postoperatively

    Number of side effects

  10. Number of drug treatments as well as the purchase price of RV from a hospital perspective

    Time frame: From day 1 to day 6 postoperatively

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: ViRAgeSS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 19, 2021
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.