the Effectiveness of Therapeutic Virtual Reality Versus Pharmacological Sedation on Pain and Anxiety During Interventional Cardiology Procedures

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Comparative Study Evaluating the Efficacy of Therapeutic Virtual Reality Versus Pharmacological Sedation on Pain and Anxiety During Interventional Cardiology Procedures

Conditions
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Virtual Reality, Drug Sedation, Coronarography, Angiography

Intervention / Treatment
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* Procedure: scheduled outpatient interventions in interventional cardiology


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Monocentric, prospective, comparative, randomized, open-label study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with virtual reality<br>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. | Procedure: scheduled outpatient interventions in interventional cardiology<br>* coronary angiography, coronary angioplasty, peripheral angioplasty (carotid arteries or lower limbs)<br>|
| Active Comparator: Patient with pharmacological sedation<br> | Procedure: scheduled outpatient interventions in interventional cardiology<br>* coronary angiography, coronary angioplasty, peripheral angioplasty (carotid arteries or lower limbs)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum pain during the interventional cardiology procedures | measured on a scale of 0 to 10. | 1 day |