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

Elsan

Status: Completed

Conditions: Coronarography; Angiography; Drug Sedation; Virtual Reality

Treatments: Procedure: scheduled outpatient interventions in interventional cardiology

Study type: Interventional

Funder types: Other

Identifiers

NCT05588232

2021-A01130-41

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Patient with virtual reality

Experimental group

Description:

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.

Treatment:

Procedure: scheduled outpatient interventions in interventional cardiology

Patient with pharmacological sedation

Active Comparator group

Treatment:

Procedure: scheduled outpatient interventions in interventional cardiology