Virtual Reality for Preoperative Anxiety in Interventional Cardiology (No PANIC)
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
VIRTUAL REALITY
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring interventional cardiopathy, preoperative anxiety, virtual reality
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
Sites / Locations
- Grenoble University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
CONTROL GROUP
INTERVENTION GROUP
Arm Description
No virtual reality
Patient equipped with Virtual reality in transfer room.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Evaluation of anxiety level in patient awaiting coronarography
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
Patient satisfaction questionnaire
Impact of virtual reality on coronarography intervention duration
Intervention duration (in minutes)
Impact of virtual reality on coronarography irradiation dose
Irradiation dose (in Gy.cm²)
Impact of virtual reality on coronarography scopy time
scopy time (in 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)
Impact of virtual reality on rate and success of coronarography procedure
number and success of PCI
Full Information
NCT ID
NCT04242563
First Posted
December 30, 2019
Last Updated
May 18, 2022
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT04242563
Brief Title
Virtual Reality for Preoperative Anxiety in Interventional Cardiology
Acronym
No PANIC
Official Title
Virtual Reality for Preoperative Anxiety in Interventional Cardiology
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 2, 2020 (Actual)
Primary Completion Date
July 12, 2021 (Actual)
Study Completion Date
July 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
interventional cardiopathy, preoperative anxiety, virtual reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CONTROL GROUP
Arm Type
No Intervention
Arm Description
No virtual reality
Arm Title
INTERVENTION GROUP
Arm Type
Experimental
Arm Description
Patient equipped with Virtual reality in transfer room.
Intervention Type
Other
Intervention Name(s)
VIRTUAL REALITY
Intervention Description
Patient equipped with virtual reality in transfer room
Primary Outcome Measure Information:
Title
Effectiveness of virutal reality on the management of preoperative anxiety measured by heart rate variability in interventional cardiology room in patient awaiting coronarography
Description
Heart rate variability during 20 minutes by a heart rate monitor in transfer room
Time Frame
Time 1 : 60 minutes
Secondary Outcome Measure Information:
Title
Evaluation of anxiety level in patient awaiting coronarography
Description
The Analogical Self-Assessment Scale for Preoperative Anxiety (0 - no anxiety to 10 - uncontrollable anxiety)
Time Frame
TIme 1 : 60 minutes, Time 2 : 120 minutes
Title
Patient satisfaction on the global care in the coronary angiography room
Description
Patient satisfaction questionnaire
Time Frame
Time 3 : 180 minutes
Title
Impact of virtual reality on coronarography intervention duration
Description
Intervention duration (in minutes)
Time Frame
Time 2 : 120 minutes
Title
Impact of virtual reality on coronarography irradiation dose
Description
Irradiation dose (in Gy.cm²)
Time Frame
Time 2 : 120 minutes
Title
Impact of virtual reality on coronarography scopy time
Description
scopy time (in minutes)
Time Frame
Time 2 : 120 minutes
Title
Impact of virtual reality on administration of analgesic and anxiolytic drug peri and per coronarography procedure
Description
administration of analgesic and anxiolytic drug peri and perprocedure (drug name and dose)
Time Frame
Time 2 : 120 minutes
Title
Impact of virtual reality on rate and success of coronarography procedure
Description
number and success of PCI
Time Frame
Time 2 : 120 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Grenoble University Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Virtual Reality for Preoperative Anxiety in Interventional Cardiology
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