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

Primary Purpose

Scoliosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual Reality (VR) technique
Analgesic protocol
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Scoliosis focused on measuring Virtual reality, Scoliosis surgery, Adolescents, Pain management

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

  • CHU ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality group

Control group

Arm Description

Adolescents aged 13 to 18 years who have undergone scoliosis surgery

Adolescents aged 13 to 18 years who have undergone scoliosis surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Morphine-related side effects
Number and nature of morphine-related side effects
Treatment prescribed to combat the side effects of morphine
Nature of treatment
Dose of treatment prescribed to combat the side effects of morphine
Dose in mg
Duration of treatment prescribed to combat the side effects of morphine
Number of days
daily dose of morphine
daily dose of morphine equivalent in milligrams (mg) then related to the weight in milligrams per kilogram (mg/kg)
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
Side effects related to the use of the virtual reality
Number of side effects
Number of drug treatments as well as the purchase price of RV from a hospital perspective

Full Information

First Posted
April 8, 2021
Last Updated
May 17, 2022
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT04892940
Brief Title
Use of Virtual Reality to Reduce Morphine Consumption in Adolescents Undergoing Scoliosis Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
Virtual reality, Scoliosis surgery, Adolescents, Pain management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality group
Arm Type
Experimental
Arm Description
Adolescents aged 13 to 18 years who have undergone scoliosis surgery
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Adolescents aged 13 to 18 years who have undergone scoliosis surgery
Intervention Type
Device
Intervention Name(s)
Virtual Reality (VR) technique
Intervention Description
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
Drug
Intervention Name(s)
Analgesic protocol
Intervention Description
Patients randomized in the "control" group receive the usual analgesic protocol of the department postoperatively.
Primary Outcome Measure Information:
Title
Cumulative amount of morphine (mg) consumed for each participant.
Time Frame
From day 1 to day 3 postoperatively
Secondary Outcome Measure Information:
Title
Intensity of pain assessed on a scale of 1 to 10.
Description
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.
Time Frame
At day 3 postoperatively
Title
Maximum level of pain assessed on a scale of 1 to 10
Description
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.
Time Frame
From day 1 to day 6 postoperatively
Title
Morphine-related side effects
Description
Number and nature of morphine-related side effects
Time Frame
Between day 1 and day 3 postoperatively
Title
Treatment prescribed to combat the side effects of morphine
Description
Nature of treatment
Time Frame
Between day 1 and day 3 postoperatively
Title
Dose of treatment prescribed to combat the side effects of morphine
Description
Dose in mg
Time Frame
Between day 1 and day 3 postoperatively
Title
Duration of treatment prescribed to combat the side effects of morphine
Description
Number of days
Time Frame
Between day 1 and day 3 postoperatively
Title
daily dose of morphine
Description
daily dose of morphine equivalent in milligrams (mg) then related to the weight in milligrams per kilogram (mg/kg)
Time Frame
From day 1 to day 6 postoperatively
Title
Cost-effectiveness ratio
Description
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
Time Frame
From day 1 to day 6 postoperatively
Title
Side effects related to the use of the virtual reality
Description
Number of side effects
Time Frame
From day 1 to day 3 postoperatively
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Servane LE GOAS UGUEN
Phone
0534558702
Email
legoasuguen.s@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Servane LE GOAS UGUEN
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Servane LE GOAS UGUEN
Phone
0534558702
Email
legoasuguen.s@chu-toulouse.fr

12. IPD Sharing Statement

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

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