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

Not Applicable

Completed

• Conditions: Drug Sedation; Angiography; Virtual Reality; Coronarography
• Interventions: Procedure: scheduled outpatient interventions in interventional cardiology

• 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

Study Timeline

• Study Start: 2021-10-18
• Primary Completion: 2021-12-11
• Study Completion: 2022-02-24
• Status Verified: 2022-10
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-20
• Last Update Submitted: 2022-10-20
• Last Update Posted: 2022-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient with pharmacological sedation	scheduled outpatient interventions in interventional cardiology	-
Patient with virtual reality	scheduled outpatient interventions in interventional cardiology	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.

Primary Outcome Measures

Name	Time	Method
Maximum pain during the interventional cardiology procedures	1 day	measured on a scale of 0 to 10.

Trial Locations

Locations (1)

Clinique Claude Bernard; 🇫🇷 Metz, France