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

Virtual Reality Clinical Trial

— VirtuCardio  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05588232
• Other study ID #: 2021-A01130-41
• Status: Completed
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: February 24, 2022

Study information

• Verified date: October 2022
• Source: Elsan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: February 24, 2022
• Est. primary completion date: December 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Angiography
• Virtual Reality

Intervention

Procedure:
• scheduled outpatient interventions in interventional cardiology
coronary angiography, coronary angioplasty, peripheral angioplasty (carotid arteries or lower limbs)

Locations

Country	Name	City	State
France	Clinique Claude Bernard	Metz

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum pain during the interventional cardiology procedures	measured on a scale of 0 to 10.	1 day