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The Effect of Using Virtual Reality Glasses on Anxiety-related Radial Vasospasm in Patients Undergoing Transradial Coronary Angiography

NCT06726031 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-10

No results posted yet for this study

Summary

Compared to transfemoral access, transradial access is a safe and effective method for coronary interventions, associated with lower rates of vascular complications, including major bleeding. Additionally, it facilitates early ambulation and reduces post-procedural hospital stays. As a result, current guidelines now recommend transradial access as the preferred approach for coronary interventional procedures. However, the most commonly recognized limitation of this method is radial artery spasm (RAS).

The radial artery is more susceptible to spasm than other peripheral arteries due to its thicker muscular layer and the predominance of alpha-adrenergic receptors. RAS can sometimes limit the advantages of transradial access, prolong procedural duration, or even lead to procedural failure and termination. Consequently, the prevention of potential causes of RAS has garnered significant interest.

The reported incidence of RAS ranges between 7.8% and 25%. These rates are notably high for diagnostic procedures, underscoring the importance of identifying and addressing risk factors before the intervention. The literature identifies several risk factors for RAS, including female sex, advanced age, smaller radial artery diameter, and the number of interventions performed.

Cardiac procedures frequently induce pain and anxiety in patients. The prevalence of anxiety disorders among patients with cardiovascular diseases can reach up to 15%, with cardiac procedures exacerbating these conditions, resulting in anxiety prevalence rates as high as 72%.

Given the limitations of pharmacological approaches in managing pain and anxiety, innovative digital solutions such as virtual reality (VR) have been proposed. However, VR was not found to have a statistically significant effect on pain levels.

The literature review revealed that, based on the current understanding, no prior studies have investigated the impact of VR headset use on anxiety-induced vasospasm in patients undergoing transradial coronary angiography. Therefore, the study aimed to explore whether VR applications could influence the successful completion of this widely performed procedure worldwide.

Conditions

  • Radial Artery Spasm
  • Radial Artery Access
  • Virtual Reality

Interventions

DEVICE

wearing VR glass

The intervention is the application of VR headsets during the procedure for patients who were previously indicated for transradial coronary angiography and were randomized to the VR headset group.

Sponsors & Collaborators

  • Mersin University

    lead OTHER

Principal Investigators

  • ahmet b KECECI, Research Assistant · Mersin University faculty of medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2025-03-01
Completion
2025-04-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06726031 on ClinicalTrials.gov