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

Scoliosis Clinical Trial

— ViRAgeSS  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04892940
• Other study ID #: RC31/20/0447
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: September 2023

Study information

• Verified date: May 2022
• Source: University Hospital, Toulouse
• Contact: Servane LE GOAS UGUEN
• Phone: 0534558702
• Email: legoasuguen.s[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Scoliosis

Intervention

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.

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative amount of morphine (mg) consumed for each participant.		From day 1 to day 3 postoperatively
Secondary	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
Secondary	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
Secondary	Morphine-related side effects	Number and nature of morphine-related side effects	Between day 1 and day 3 postoperatively
Secondary	Treatment prescribed to combat the side effects of morphine	Nature of treatment	Between day 1 and day 3 postoperatively
Secondary	Dose of treatment prescribed to combat the side effects of morphine	Dose in mg	Between day 1 and day 3 postoperatively
Secondary	Duration of treatment prescribed to combat the side effects of morphine	Number of days	Between day 1 and day 3 postoperatively
Secondary	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
Secondary	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
Secondary	Side effects related to the use of the virtual reality	Number of side effects	From day 1 to day 3 postoperatively
Secondary	Number of drug treatments as well as the purchase price of RV from a hospital perspective		From day 1 to day 6 postoperatively