Coronary Angiography THerapeutic Virtual Reality
Sleutelwoorden
Abstract
Omschrijving
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.
Datums
| Laatst geverifieerd: | 04/30/2018 |
| Eerste ingediend: | 03/29/2018 |
| Geschatte inschrijving ingediend: | 03/29/2018 |
| Eerst geplaatst: | 04/05/2018 |
| Laatste update ingediend: | 05/03/2018 |
| Laatste update geplaatst: | 05/06/2018 |
| Werkelijke startdatum van het onderzoek: | 05/31/2018 |
| Geschatte primaire voltooiingsdatum: | 06/29/2018 |
| Geschatte voltooiingsdatum van het onderzoek: | 06/29/2018 |
Conditie of ziekte
Interventie / behandeling
Device: VR with or without Moderate Sedation
Drug: Fentanyl Injection
Drug: Midazolam injection
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| 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: VR with or without Moderate Sedation 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. |
| 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. |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 18 Years Naar 18 Years |
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| 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. |
Resultaat
Primaire uitkomstmaten
1. Radial Artery Vasospasm [Day 1]
2. Pain [Day 1]
3. Anxiety [Day 1]
Secundaire uitkomstmaten
1. Total fentanyl sedation [Day 1]
2. Total midazolam sedation [Day 1]
