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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242563
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : May 19, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : February 2, 2020
Actual Primary Completion Date : July 12, 2021
Actual Study Completion Date : July 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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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
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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 Frame: 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 Frame: 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 Frame: Time 3 : 180 minutes ]
    Patient satisfaction questionnaire

  3. Impact of virtual reality on coronarography intervention duration [ Time Frame: Time 2 : 120 minutes ]
    Intervention duration (in minutes)

  4. Impact of virtual reality on coronarography irradiation dose [ Time Frame: Time 2 : 120 minutes ]
    Irradiation dose (in Gy.cm²)

  5. Impact of virtual reality on coronarography scopy time [ Time Frame: 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 Frame: 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 Frame: Time 2 : 120 minutes ]
    number and success of PCI


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242563


Locations
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France
Grenoble University Hospital
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
More Information
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04242563    
Other Study ID Numbers: 38RC19.116
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Anxiety Disorders
Mental Disorders