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Coronary Angiography THerapeutic Virtual Reality (CATH-VR)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490903
Recruitment Status : Not yet recruiting
First Posted : April 6, 2018
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
AppliedVR Inc.
Information provided by (Responsible Party):
David J. Cho, MD, MBA, University of California, Los Angeles

Brief Summary:
The CATH-VR study will investigate the effect of virtual reality (VR) on patient pain, anxiety, and radial artery vasospasm during coronary angiography. Our hypothesis is that the use of VR will decrease patient anxiety and pain via validated scoring systems, as well as show a low rate of vasospasm of the radial artery. In addition, we hypothesize that the amount of opioid and benzodiazepine medications utilized for procedural sedation will be lower in the intervention arm. VR has gained recent attraction as an alternative or adjunctive treatment option for pain, but its effect on reducing procedural sedation has not been studied. We propose a single center, randomized control pilot study to further investigate. The patient population will include adults older than 18 years who present for outpatient diagnostic coronary angiography.

Condition or disease Intervention/treatment Phase
Virtual Reality Atherosclerosis Coronary Artery Disease Anxiety Pain, Acute Vasospasm;Peripheral Device: Virtual Reality Drug: Fentanyl Injection Drug: Midazolam injection Not Applicable

Detailed Description:

We plan to conduct a prospective, unblinded, randomized control pilot study to test our hypothesis that the use of VR will decrease patient anxiety and pain via validated scoring systems, as well as show a low rate of vasospasm of the radial artery.

Patients will be eligible if they are greater than 18 years of age and undergoing an elective outpatient coronary angiogram with or without percutaneous intervention. Exclusion criteria will include patients with claustrophobia, seizure disorder, motion sickness, stroke within the past year, dementia, nausea, isolation status for infection control or those who do not wish to participate.

Outpatients undergoing routine coronary angiography with or without possible percutaneous intervention will be screened for enrollment criteria. Those who agree to participate will be randomized to either the intervention or control arm. Those randomized to the intervention arm and agree to participate in the study will wear a VR Headset and headphones; those who are randomized to the control will receive the standard of care, which is moderate sedation for patient anxiolysis and pain control during the case. In both arms, the patient and operator will still be able to communicate verbally if needed to assess for pain, to ask questions, or to ask for anxiolytic or analgesic medications as needed. The procedure will be completed when vascular sheaths are just about to be removed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Coronary Angiography THerapeutic Virtual Reality: Investigating the Effect of Virtual Reality on Procedural Anxiety, Pain and Vasospasm
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: VR with or without Moderate Sedation

Patients randomized to receive a Virtual Reality Intervention will be fitted with a VR headset and headphones and undergo a continuous immersive meditation experience. This will begin immediately prior to the start of the procedure, and continue until the procedure is completed.

Patient pain and anxiety levels will be frequently assessed by procedure operator and circulating nurse, and pain medication or anxiolytic medications will be administered in the absence of contraindications. Baseline amounts of sedation pre-procedurally will not be used in either arm. Pain and Anxiety Scores will be assessed pre, intra, and post-procedurally. If no contraindications, the operator will decide upon how much sedation medication to administer if indicated or requested. This is the usual manner in which pain and anxiety is treated in the cath lab.

Device: Virtual Reality
Subjects undergoing the Virtual Reality Intervention will be fitted with a VR headset and headphones, and undergo an immersive meditation experience provided by AppliedVR, Inc. The headphones will not be noise-cancelling, and the subject will be able to communicate with the physician or circulating nurse if needed.

Drug: Fentanyl Injection
Fentanyl is commonly administered to treat pain during invasive procedures such as coronary angiography. Intravenous fentanyl injection dosages are determined by the physician operator, and administered by the circulating nurse.

Drug: Midazolam injection
Midazolam is commonly administered to treat anxiety during invasive procedures such as coronary angiography. Intravenous midazolam injection dosages are determined by the physician operator, and administered by the circulating nurse.

Active Comparator: Moderate Sedation without VR
Subjects randomized to the comparison arm will not undergo the Virtual Reality Intervention. Baseline amounts of sedation pre-procedurally will not be used in either arm. Subjects will be assessed periodically by physicians and/or circulating nurses for their pain and anxiety levels. The patient may also prompt the staff that they are anxious or in pain, and if no contraindications, the operator will decide upon how much medication to administer. This is the usual manner in which pain and anxiety is treated in the cath lab.
Drug: Fentanyl Injection
Fentanyl is commonly administered to treat pain during invasive procedures such as coronary angiography. Intravenous fentanyl injection dosages are determined by the physician operator, and administered by the circulating nurse.

Drug: Midazolam injection
Midazolam is commonly administered to treat anxiety during invasive procedures such as coronary angiography. Intravenous midazolam injection dosages are determined by the physician operator, and administered by the circulating nurse.




Primary Outcome Measures :
  1. Radial Artery Vasospasm [ Time Frame: Day 1 ]
    Presence or Absence of Radial Artery Vasospasm, determined by procedure operator

  2. Pain [ Time Frame: Day 1 ]
    Participants will verbalize their level of pain using the Wong-Baker FACES® Score (0 - 10 point scale, 10 points = worst pain, 0 = no pain).

  3. Anxiety [ Time Frame: Day 1 ]
    Participants will verbalize their level of anxiety by using the abbreviated State-Trait Anxiety Inventory 6 Score (Score Range 20-80, higher numbers correlate with higher levels of anxiety in a certain moment)


Secondary Outcome Measures :
  1. Total fentanyl sedation [ Time Frame: Day 1 ]
    The total dose of fentanyl administered during the procedure

  2. Total midazolam sedation [ Time Frame: Day 1 ]
    The total dose of midazolam administered during the procedure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Age greater than or equal to 18 years undergoing diagnostic coronary angiogram

Exclusion Criteria:

  • Claustrophobia
  • Seizure disorder
  • Motion sickness
  • Stroke within the past year
  • Dementia
  • Nausea
  • Isolation status for infection control
  • Do not wish to participate.

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): NCT03490903


Contacts
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Contact: David Cho, MD 310-206-6766 ext 28110 djcho@mednet.ucla.edu
Contact: Weiyi Tan, MD 310-206-6766 ext 28149 weiyitan@mednet.ucla.edu

Sponsors and Collaborators
University of California, Los Angeles
AppliedVR Inc.
Investigators
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Principal Investigator: David Cho, MD University of California, Los Angeles

Publications:
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Responsible Party: David J. Cho, MD, MBA, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03490903    
Other Study ID Numbers: IRB#18-000026
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by David J. Cho, MD, MBA, University of California, Los Angeles:
virtual reality
anxiety
vasospasm
pain
coronary artery angiography
angiogram
VR
Additional relevant MeSH terms:
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Coronary Artery Disease
Atherosclerosis
Acute Pain
Anxiety Disorders
Mental Disorders
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Midazolam
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Hypnotics and Sedatives
Anti-Anxiety Agents