Virtual Reality for Preoperative Anxiety in Interventional Cardiology

Study Overview
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Brief Summary
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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.

Official Title
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Virtual Reality for Preoperative Anxiety in Interventional Cardiology

Conditions
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Anxiety

Intervention / Treatment
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* Other: VIRTUAL REALITY


Participation Criteria
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Eligibility Criteria
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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 Patient under administrative or judicial supervision Foreign patient who does not understand French Major patient protected by law (article L1121-8 and L1121-5) Pregnant or lactating patient Patient not affiliated with social security

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CONTROL GROUP<br>No virtual reality | |
| Experimental: INTERVENTION GROUP<br>Patient equipped with Virtual reality in transfer room. | Other: VIRTUAL REALITY<br>* Patient equipped with virtual reality in transfer room<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of virutal reality on the management of preoperative anxiety measured by heart rate variability in interventional cardiology room in patient awaiting coronarography | Heart rate variability during 20 minutes by a heart rate monitor in transfer room | Time 1 : 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of anxiety level in patient awaiting coronarography | The Analogical Self-Assessment Scale for Preoperative Anxiety (0 - no anxiety to 10 - uncontrollable anxiety) | TIme 1 : 60 minutes, Time 2 : 120 minutes | 
| Patient satisfaction on the global care in the coronary angiography room | Patient satisfaction questionnaire | Time 3 : 180 minutes | 
| Impact of virtual reality on coronarography intervention duration | Intervention duration (in minutes) | Time 2 : 120 minutes | 
| Impact of virtual reality on coronarography irradiation dose | Irradiation dose (in Gy.cm²) | Time 2 : 120 minutes | 
| Impact of virtual reality on coronarography scopy time | scopy time (in minutes) | Time 2 : 120 minutes | 
| Impact of virtual reality on administration of analgesic and anxiolytic drug peri and per coronarography procedure | administration of analgesic and anxiolytic drug peri and perprocedure (drug name and dose) | Time 2 : 120 minutes | 
| Impact of virtual reality on rate and success of coronarography procedure | number and success of PCI | Time 2 : 120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interventional cardiopathy, preoperative anxiety, virtual reality