An interventional study of Virtual Reality and Fentanyl Injection in Virtual Reality, Atherosclerosis and Coronary Artery Disease, sponsored by University of California, Los Angeles. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-16.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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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.
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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Exclusion Criteria:
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 · Drug: Fentanyl Injection · Drug: Midazolam injection
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 · Drug: Midazolam injection
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.
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.
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.
Radial Artery Vasospasm
Presence or Absence of Radial Artery Vasospasm, determined by procedure operator
Time frame: 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).
Time frame: 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)
Time frame: Day 1
Total fentanyl sedation
The total dose of fentanyl administered during the procedure
Time frame: Day 1
Total midazolam sedation
The total dose of midazolam administered during the procedure
Time frame: Day 1
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jun 2018; primary completion for Jun 2018, 0 months later.
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This study is withdrawn, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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