Coronary Artery Disease Clinical Trial
— CATH-VROfficial title:
Coronary Angiography THerapeutic Virtual Reality: Investigating the Effect of Virtual Reality on Procedural Anxiety, Pain and Vasospasm
Verified date | November 2021 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of California, Los Angeles | AppliedVR Inc. |
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radial Artery Vasospasm | Presence or Absence of Radial Artery Vasospasm, determined by procedure operator | Day 1 | |
Primary | Pain | Participants will verbalize their level of pain using the Wong-Baker FACESĀ® Score (0 - 10 point scale, 10 points = worst pain, 0 = no pain). | Day 1 | |
Primary | 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 | Total fentanyl sedation | The total dose of fentanyl administered during the procedure | Day 1 | |
Secondary | Total midazolam sedation | The total dose of midazolam administered during the procedure | Day 1 |
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