Clinical trial NCT04242563: Virtual Reality for Preoperative Anxiety in Interventional Cardiology
Official title: Virtual Reality for Preoperative Anxiety in Interventional Cardiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: interventional cardiopathy
preoperative anxiety
virtual reality
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Effectiveness of virutal reality on the management of preoperative anxiety measured by heart rate variability in interventional cardiology room in patient awaiting coronarography
timeFrame: Time 1 : 60 minutes
Secondary outcomes:
measure: Evaluation of anxiety level in patient awaiting coronarography
timeFrame: TIme 1 : 60 minutes, Time 2 : 120 minutes
measure: Patient satisfaction on the global care in the coronary angiography room
timeFrame: Time 3 : 180 minutes
measure: Impact of virtual reality on coronarography intervention duration
timeFrame: Time 2 : 120 minutes
measure: Impact of virtual reality on coronarography irradiation dose
timeFrame: Time 2 : 120 minutes
measure: Impact of virtual reality on coronarography scopy time
timeFrame: Time 2 : 120 minutes
measure: Impact of virtual reality on administration of analgesic and anxiolytic drug peri and per coronarography procedure
timeFrame: Time 2 : 120 minutes
measure: Impact of virtual reality on rate and success of coronarography procedure
timeFrame: Time 2 : 120 minutes
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
Study officials:
References: