ScoliosisViRAgeSSNCT04892940
Use of Virtual Reality to Reduce Morphine Consumption in Adolescents Undergoing Scoliosis Surgery
A study testing Virtual Reality (VR) technique and Analgesic protocol in people with Scoliosis, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Virtual Reality (VR) technique and Analgesic protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2022to 24 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Virtual Reality (VR) technique, Analgesic protocol
- Keywords
- Virtual reality, Scoliosis surgery, Adolescents, Pain management
- Medical subject headings
- Scoliosis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR) techniqueDevice
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 protocolDrug
Patients randomized in the "control" group receive the usual analgesic protocol of the department postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality group | Experimental | Adolescents aged 13 to 18 years who have undergone scoliosis surgery Receives: Device: Virtual Reality (VR) technique; Drug: Analgesic protocol |
| Control group | Active comparator | Adolescents aged 13 to 18 years who have undergone scoliosis surgery Receives: Drug: Analgesic protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative amount of morphine (mg) consumed for each participant.
Measured: From day 1 to day 3 postoperatively
Secondary outcomes (10)
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.
Measured: At day 3 postoperatively
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.
Measured: From day 1 to day 6 postoperatively
Morphine-related side effects
Number and nature of morphine-related side effects
Measured: Between day 1 and day 3 postoperatively
Treatment prescribed to combat the side effects of morphine
Nature of treatment
Measured: Between day 1 and day 3 postoperatively
Dose of treatment prescribed to combat the side effects of morphine
Dose in mg
Measured: Between day 1 and day 3 postoperatively
Duration of treatment prescribed to combat the side effects of morphine
Number of days
Measured: Between day 1 and day 3 postoperatively
daily dose of morphine
daily dose of morphine equivalent in milligrams (mg) then related to the weight in milligrams per kilogram (mg/kg)
Measured: From day 1 to day 6 postoperatively
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
Measured: From day 1 to day 6 postoperatively
Side effects related to the use of the virtual reality
Number of side effects
Measured: From day 1 to day 3 postoperatively
Number of drug treatments as well as the purchase price of RV from a hospital perspective
Measured: From day 1 to day 6 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start21 Feb 2022
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Servane LE GOAS UGUEN, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892940
- Sponsor's protocol ID
- RC31/20/0447
- Acronym
- ViRAgeSS
- Status last verified
- Jan 2025
- First submitted
- 8 Apr 2021
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04892940
- Acronym / sponsor ID
- ViRAgeSS / RC31/20/0447
- Conditions
- Scoliosis
- Keywords
- Virtual reality, Scoliosis surgery, Adolescents, Pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality group | Experimental | Device: Virtual Reality (VR) technique, Drug: Analgesic protocolAdolescents aged 13 to 18 years who have undergone scoliosis surgery |
| Control group | Active comparator | Drug: Analgesic protocolAdolescents aged 13 to 18 years who have undergone scoliosis surgery |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality (VR) techniqueThe "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. | Device | Virtual Reality group |
| Analgesic protocolPatients randomized in the "control" group receive the usual analgesic protocol of the department postoperatively. | Drug | Control group, Virtual Reality group |
Primary outcome
Cumulative amount of morphine (mg) consumed for each participant.
Time frame: From day 1 to day 3 postoperatively
10 secondary outcomes
Intensity of pain assessed on a scale of 1 to 10.
Time frame: At day 3 postoperatively
Maximum level of pain assessed on a scale of 1 to 10
Time frame: From day 1 to day 6 postoperatively
Morphine-related side effects
Time frame: Between day 1 and day 3 postoperatively
Treatment prescribed to combat the side effects of morphine
Time frame: Between day 1 and day 3 postoperatively
Dose of treatment prescribed to combat the side effects of morphine
Time frame: Between day 1 and day 3 postoperatively
Duration of treatment prescribed to combat the side effects of morphine
Time frame: Between day 1 and day 3 postoperatively
daily dose of morphine
Time frame: From day 1 to day 6 postoperatively
Cost-effectiveness ratio
Time frame: From day 1 to day 6 postoperatively
Side effects related to the use of the virtual reality
Time frame: From day 1 to day 3 postoperatively
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Servane LE GOAS UGUEN principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality (VR) technique and Analgesic protocol in people with Scoliosis, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative amount of morphine (mg) consumed for each participant. (time frame: From day 1 to day 3 postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.