Angiography, Coronarography, Drug Sedation, Virtual Reality
Conditions
Brief summary
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.
Interventions
PROCEDUREscheduled outpatient interventions in interventional cardiology
coronary angiography, coronary angioplasty, peripheral angioplasty (carotid arteries or lower limbs)
Sponsors
Elsan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Monocentric, prospective, comparative, randomized, open-label study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient * who must benefit from one of the following scheduled interventional cardiology outpatient procedures: coronary angiography, coronary angioplasty, peripheral angioplasty (lower limbs) * Affiliation to a social security scheme or beneficiary of such a scheme. * Patient having signed the free and informed consent
Exclusion criteria
* Dementia * Language barrier * Claustrophobia * Nausea * History of intolerance to Virtual Reality * Patient with epilepsy * Refusal to participate in the study * Protected patient: minor, adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision * Pregnant, breastfeeding or parturient woman * Unstable patient (state of shock, respiratory or neurological distress)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum pain during the interventional cardiology procedures | 1 day | measured on a scale of 0 to 10. |
Countries
France
Outcome results
None listed