Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT03490903
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.
Study:
NCT03490903
Study Brief:
Protocol Section:
NCT03490903