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Clinical Trials/NCT04242563
NCT04242563
Completed
Not Applicable

Virtual Reality for Preoperative Anxiety in Interventional Cardiology

University Hospital, Grenoble1 site in 1 country156 target enrollmentFebruary 2, 2020
ConditionsAnxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
University Hospital, Grenoble
Enrollment
156
Locations
1
Primary Endpoint
Effectiveness of virutal reality on the management of preoperative anxiety measured by heart rate variability in interventional cardiology room in patient awaiting coronarography
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

Improving the management of perioperative anxiety is important. Anxiety can have an impact on the intervention and can increase postoperative complications as well as emotional and behavioral incidents that then have an impact on adherence to care. These findings are also true in interventional cardiology. That is why, for several months, the Grenoble University hospital paramedical team, in collaboration with the medical profession, improved by using several techniques (educational sheet, therapeutic communication). Following a survey of the patients of Grenoble university hospital, a gray area persists in their care. The room where the patient attends his examination. The investigators would then use the new technology that makes virtual reality in the transfer room to evaluate its benefit in a random study on preoperative anxiety in interventional cardiology.

Registry
clinicaltrials.gov
Start Date
February 2, 2020
End Date
July 12, 2021
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Major male or female patient
  • Coronarography procedure programmed for exploration of coronary artery disease following a positive ischemia test, realized in ambulatory
  • Patient who has given written consent to participate in the study

Exclusion Criteria

  • Arrhythmia patient and / or patient with a pacemaker
  • Hemodynamic instability
  • Patient who has already had coronarography
  • Prior revascularization by coronary bypass
  • End-stage renal disease (Creatinine clearance \<30 ml / min),
  • Allergy to iodine contrast agent
  • Blind or visually impaired patient (high degree)
  • Deaf or hard of hearing patient
  • Patient with claustrophobia or unable to wear a mask over the eyes
  • Patient whose physical or psychological state could compromise obtaining informed consent and compliance with protocol requirements

Outcomes

Primary Outcomes

Effectiveness of virutal reality on the management of preoperative anxiety measured by heart rate variability in interventional cardiology room in patient awaiting coronarography

Time Frame: Time 1 : 60 minutes

Heart rate variability during 20 minutes by a heart rate monitor in transfer room

Secondary Outcomes

  • Impact of virtual reality on coronarography scopy time(Time 2 : 120 minutes)
  • Evaluation of anxiety level in patient awaiting coronarography(TIme 1 : 60 minutes, Time 2 : 120 minutes)
  • Patient satisfaction on the global care in the coronary angiography room(Time 3 : 180 minutes)
  • Impact of virtual reality on coronarography intervention duration(Time 2 : 120 minutes)
  • Impact of virtual reality on coronarography irradiation dose(Time 2 : 120 minutes)
  • Impact of virtual reality on administration of analgesic and anxiolytic drug peri and per coronarography procedure(Time 2 : 120 minutes)
  • Impact of virtual reality on rate and success of coronarography procedure(Time 2 : 120 minutes)

Study Sites (1)

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