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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality group | Experimental | Adolescents aged 13 to 18 years who have undergone scoliosis surgery |
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| Control group | Active Comparator | Adolescents aged 13 to 18 years who have undergone scoliosis surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative amount of morphine (mg) consumed for each participant. | From day 1 to day 3 postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Maximum level of pain assessed on a scale of 1 to 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Servane LE GOAS UGUEN | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Toulouse | Toulouse | France |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Analgesic protocol | Drug | Patients randomized in the "control" group receive the usual analgesic protocol of the department 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.
| From day 1 to day 6 postoperatively |
| Morphine-related side effects | Number and nature of morphine-related side effects | Between day 1 and day 3 postoperatively |
| Treatment prescribed to combat the side effects of morphine | Nature of treatment | Between day 1 and day 3 postoperatively |
| Dose of treatment prescribed to combat the side effects of morphine | Dose in mg | Between day 1 and day 3 postoperatively |
| Duration of treatment prescribed to combat the side effects of morphine | Number of days | 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) | 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 | From day 1 to day 6 postoperatively |
| Side effects related to the use of the virtual reality | Number of side effects | From day 1 to day 3 postoperatively |
| Number of drug treatments as well as the purchase price of RV from a hospital perspective | From day 1 to day 6 postoperatively |
| D010468 |
| Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |