Virtual Reality for Preoperative Anxiety in Interventional Cardiology

Anxiety Clinical Trial

— No PANIC  

Official title:

Virtual Reality for Preoperative Anxiety in Interventional Cardiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04242563
• Other study ID #: 38RC19.116
• Status: Completed
• Phase: N/A
• Start date: February 2, 2020
• Est. completion date: July 12, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: July 12, 2021
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• VIRTUAL REALITY
Patient equipped with virtual reality in transfer room

Locations

Country	Name	City	State
France	Grenoble University Hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Patient satisfaction on the global care in the coronary angiography room	Patient satisfaction questionnaire	Time 3 : 180 minutes
Secondary	Impact of virtual reality on coronarography intervention duration	Intervention duration (in minutes)	Time 2 : 120 minutes
Secondary	Impact of virtual reality on coronarography irradiation dose	Irradiation dose (in Gy.cm²)	Time 2 : 120 minutes
Secondary	Impact of virtual reality on coronarography scopy time	scopy time (in minutes)	Time 2 : 120 minutes
Secondary	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
Secondary	Impact of virtual reality on rate and success of coronarography procedure	number and success of PCI	Time 2 : 120 minutes