Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Immersion sedation in virtual reality could be an alternative to conventional pharmacological sedation, during interventional cardiology acts on pain and anxiety control.
The objective of this study is to determine whether virtual reality immersion is non-inferior to drug sedation on pain and anxiety, during coronary angiography or angioplasty.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with virtual reality | Experimental | The virtual reality sedation-analgesia solution developed by Deepsen combines 3D environment content with medical hypnosis techniques. The technology includes a wearable visual headset that contains head movement sensors, enabling patient interaction in the virtual environment, as well as isolating headphones. |
|
| Patient with pharmacological sedation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| scheduled outpatient interventions in interventional cardiology | Procedure | coronary angiography, coronary angioplasty, peripheral angioplasty (carotid arteries or lower limbs) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum pain during the interventional cardiology procedures | measured on a scale of 0 to 10. | 1 day |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Claude Bernard | Metz | 57070 | France |
Not provided
Monocentric, prospective, comparative, randomized, open-label study.
Not provided
Not provided
Not provided
Not provided