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

NCT05588232 | Completed

• 1 other identifier: 2021-A01130-41
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality; Drug Sedation; Coronarography; Angiography

Outcome Measures

Primary Outcomes (1)

• Maximum pain during the interventional cardiology procedures

  measured on a scale of 0 to 10.

  1 day

Study Arms (2)

Patient with virtual reality

EXPERIMENTAL

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.

Procedure: scheduled outpatient interventions in interventional cardiology

Patient with pharmacological sedation

ACTIVE COMPARATOR

Procedure: scheduled outpatient interventions in interventional cardiology

Interventions

scheduled outpatient interventions in interventional cardiology PROCEDURE

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

Patient with pharmacological sedation; Patient with virtual reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Clinique Claude Bernard

Metz, 57070, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, prospective, comparative, randomized, open-label study.

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 20, 2022
• Study Start: October 18, 2021
• Primary Completion: December 11, 2021
• Study Completion: February 24, 2022
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

FR (1)