No PANIC: Virtual Reality for Preoperative Anxiety in Interventional Cardiology

• Sponsor: University Hospital, Grenoble (Other)
• Overall Status: Completed
• CT.gov ID: NCT04242563
• Collaborator: (none)
• Enrollment: 156
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.3
• Patients Per Site Per Month: 9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Other: VIRTUAL REALITY	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 156 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Virtual Reality for Preoperative Anxiety in Interventional Cardiology
• Actual Study Start Date: Feb 2, 2020
• Actual Primary Completion Date: Jul 12, 2021
• Actual Study Completion Date: Jul 12, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. Patient satisfaction on the global care in the coronary angiography room [Time 3 : 180 minutes]

   Patient satisfaction questionnaire

3. Impact of virtual reality on coronarography intervention duration [Time 2 : 120 minutes]

   Intervention duration (in minutes)

4. Impact of virtual reality on coronarography irradiation dose [Time 2 : 120 minutes]

   Irradiation dose (in Gy.cm²)

5. Impact of virtual reality on coronarography scopy time [Time 2 : 120 minutes]

   scopy time (in minutes)

6. 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)

7. Impact of virtual reality on rate and success of coronarography procedure [Time 2 : 120 minutes]

   number and success of PCI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grenoble University Hospital	Grenoble		France	38043

Sponsors and Collaborators

• University Hospital, Grenoble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT04242563
• Other Study ID Numbers: 38RC19.116
• First Posted: Jan 27, 2020
• Last Update Posted: May 19, 2022
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Grenoble: interventional cardiopathy; preoperative anxiety; virtual reality
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of May 19, 2022