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Clinical Trials/NCT05588232
NCT05588232
Completed
Not Applicable

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

Elsan1 site in 1 country136 target enrollmentOctober 18, 2021
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ConditionsVirtual RealityDrug SedationCoronarographyAngiography

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Virtual Reality
Sponsor
Elsan
Enrollment
136
Locations
1
Primary Endpoint
Maximum pain during the interventional cardiology procedures
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 18, 2021
End Date
February 24, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Elsan
Responsible Party
Sponsor

Eligibility Criteria

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

  • •Language barrier
  • •Claustrophobia
  • •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)

Outcomes

Primary Outcomes

Maximum pain during the interventional cardiology procedures

Time Frame: 1 day

measured on a scale of 0 to 10.

Study Sites (1)

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