Virtual Reality for Preoperative Anxiety in Interventional Cardiology (No PANIC)

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Other: VIRTUAL REALITY

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Grenoble University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: CONTROL GROUP; No virtual reality
Experimental: INTERVENTION GROUP; Patient equipped with Virtual reality in transfer room.	Other: VIRTUAL REALITY; Patient equipped with virtual reality in transfer room

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Publications and helpful links

General Publications

• Larsson CE, Cabassut V, Peretout P, Marliere S, Vautrin E, Piliero N, Salvat M, Riou L, Vanzetto G, Vilotitch A, Bosson JL, Barone-Rochette G. Assessment of the Objective Effect of Virtual Reality for Preoperative Anxiety in Interventional Cardiology. Am J Cardiol. 2023 Oct 15;205:207-213. doi: 10.1016/j.amjcard.2023.07.130. Epub 2023 Aug 21.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2020
• Primary Completion (Actual): July 12, 2021
• Study Completion (Actual): July 12, 2021

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: virtual reality; preoperative anxiety; interventional cardiopathy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 38RC19.116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No