Clinical trial NCT03490903: Coronary Angiography THerapeutic Virtual Reality
Official title: Coronary Angiography THerapeutic Virtual Reality: Investigating the Effect of Virtual Reality on Procedural Anxiety, Pain and Vasospasm
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Virtual Reality
Atherosclerosis
Coronary Artery Disease
Anxiety
Pain, Acute
Vasospasm;Peripheral
Keywords: virtual reality
anxiety
vasospasm
pain
coronary artery angiography
angiogram
VR
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: AppliedVR Inc.
First posted: 2018-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Radial Artery Vasospasm
timeFrame: Day 1
measure: Pain
timeFrame: Day 1
measure: Anxiety
timeFrame: Day 1
Secondary outcomes:
measure: Total fentanyl sedation
timeFrame: Day 1
measure: Total midazolam sedation
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Los Angeles
name: David Cho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.