NCT05588232CompletedNot Applicable
Prospective Randomized Comparative Study Evaluating the Efficacy of Therapeutic Virtual Reality Versus Pharmacological Sedation on Pain and Anxiety During Interventional Cardiology Procedures
Elsan2 sites in 1 country136 target enrollmentStarted: October 18, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 136
- Locations
- 2
- Primary Endpoint
- Maximum pain during the interventional cardiology procedures
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Virtual Reality as an alternative for sedation with colonoscopy; a questionnairensedated colonoscopy with Virtual RealityNL-OMON19884The department of Medical Psychology, Martini Hospital385
Recruiting
Not Applicable
Use of Virtual Reality Technology as a Sedation Replacement During ColonoscopyPatient SatisfactionNCT05701566Sheba Medical Center60
Completed
Not Applicable
Virtual Reality as a Substitute for Procedural Sedation During Epidural Steroid InjectionsLower Back PainLumbar RadiculopathyNCT04887285Johns Hopkins University146
Recruiting
Not Applicable
Minimally Invasive Superficial Venous Insufficiency Surgery and Digital SedationSuperficial Venous InsufficiencyNCT06228365GCS Ramsay Santé pour l'Enseignement et la Recherche400
Recruiting
Not Applicable
VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee PainPain, ChronicNCT06336447Northwestern University62