the Effectiveness of Therapeutic Virtual Reality Versus Pharmacological Sedation on Pain and Anxiety During Interventional Cardiology Procedures
- Conditions
- Drug SedationAngiographyVirtual RealityCoronarography
- Registration Number
- NCT05588232
- Lead Sponsor
- Elsan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Maximum pain during the interventional cardiology procedures 1 day measured on a scale of 0 to 10.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Clinique Claude Bernard
🇫🇷Metz, France
Clinique Claude Bernard🇫🇷Metz, France