Virtual Reality for Preoperative Anxiety in Interventional Cardiology
- Conditions
- Anxiety
- Interventions
- Other: VIRTUAL REALITY
- Registration Number
- NCT04242563
- Lead Sponsor
- University Hospital, Grenoble
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INTERVENTION GROUP VIRTUAL REALITY Patient equipped with Virtual reality in transfer room.
- Primary Outcome Measures
Name Time Method Effectiveness of virutal reality on the management of preoperative anxiety measured by heart rate variability in interventional cardiology room in patient awaiting coronarography Time 1 : 60 minutes Heart rate variability during 20 minutes by a heart rate monitor in transfer room
- Secondary Outcome Measures
Name Time Method Impact of virtual reality on coronarography scopy time Time 2 : 120 minutes scopy time (in minutes)
Evaluation of anxiety level in patient awaiting coronarography TIme 1 : 60 minutes, Time 2 : 120 minutes The Analogical Self-Assessment Scale for Preoperative Anxiety (0 - no anxiety to 10 - uncontrollable anxiety)
Patient satisfaction on the global care in the coronary angiography room Time 3 : 180 minutes Patient satisfaction questionnaire
Impact of virtual reality on coronarography intervention duration Time 2 : 120 minutes Intervention duration (in minutes)
Impact of virtual reality on coronarography irradiation dose Time 2 : 120 minutes Irradiation dose (in Gy.cm²)
Impact of virtual reality on administration of analgesic and anxiolytic drug peri and per coronarography procedure Time 2 : 120 minutes administration of analgesic and anxiolytic drug peri and perprocedure (drug name and dose)
Impact of virtual reality on rate and success of coronarography procedure Time 2 : 120 minutes number and success of PCI
Trial Locations
- Locations (1)
Grenoble University Hospital
🇫🇷Grenoble, France