Coronary Angiography THerapeutic Virtual Reality

Coronary Artery Disease Clinical Trial

— CATH-VR  

Official title:

Coronary Angiography THerapeutic Virtual Reality: Investigating the Effect of Virtual Reality on Procedural Anxiety, Pain and Vasospasm

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03490903
• Other study ID #: IRB#18-000026
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: November 2021
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Acute Pain
• Anxiety
• Anxiety Disorders
• Atherosclerosis
• Coronary Artery Disease
• Pain, Acute
• Vasospasm;Peripheral
• Virtual Reality

Intervention

Device:
• Virtual Reality
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.

Drug:
• Fentanyl Injection
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 injection
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	AppliedVR Inc.

References & Publications (3)

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

Outcome

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 FACES® 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