Coronary Angiography THerapeutic Virtual Reality (CATH-VR)

Coronary Angiography THerapeutic Virtual Reality: Investigating the Effect of Virtual Reality on Procedural Anxiety, Pain and Vasospasm

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.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease; Atherosclerosis; Anxiety; Pain, Acute; Virtual Reality; Vasospasm;Peripheral
• Intervention / Treatment: Device: Virtual Reality; Drug: Fentanyl Injection; Drug: Midazolam injection

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial Artery Vasospasm	Presence or Absence of Radial Artery Vasospasm, determined by procedure operator	Day 1
Pain	Participants will verbalize their level of pain using the Wong-Baker FACES® Score (0 - 10 point scale, 10 points = worst pain, 0 = no pain).	Day 1
Anxiety	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)	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total fentanyl sedation	The total dose of fentanyl administered during the procedure	Day 1
Total midazolam sedation	The total dose of midazolam administered during the procedure	Day 1

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.
• Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.
• Buffum MD, Sasso C, Sands LP, Lanier E, Yellen M, Hayes A. A music intervention to reduce anxiety before vascular angiography procedures. J Vasc Nurs. 2006 Sep;24(3):68-73; quiz 74. doi: 10.1016/j.jvn.2006.04.001.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2018
• Primary Completion (Anticipated): June 30, 2018
• Study Completion (Anticipated): June 30, 2018

Study Registration Dates

• First Submitted: March 30, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 6, 2018

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: pain; anxiety; virtual reality; vasospasm; VR; coronary artery angiography; angiogram
• Additional Relevant MeSH Terms: Mental Disorders; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Coronary Artery Disease; Anxiety Disorders; Acute Pain; Atherosclerosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Fentanyl; Midazolam
• Other Study ID Numbers: IRB#18-000026

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
• product manufactured in and exported from the U.S.: No