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

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.

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Key information

Conditions

Virtual Reality Angiography Coronarography Drug Sedation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Claude Bernard

Metz, 57070, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

scheduled outpatient interventions in interventional cardiology

Procedure

coronary angiography, coronary angioplasty, peripheral angioplasty (carotid arteries or lower limbs)

Primary outcomes

Maximum pain during the interventional cardiology procedures

Time frame: 1 day

measured on a scale of 0 to 10.

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study title

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

Acronym: VirtuCardio

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2022
First posted: Oct 20, 2022
Registry last updated: Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed