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

NCT06726031 | Not Yet Recruiting

• 1 other identifier: MersinU-CAR-ABK-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

radial artery spasm; virtual reality; anxiety

Outcome Measures

Primary Outcomes (1)

• the Visual Analog Scale (VAS)

  Visual Analog Scale (VAS) is used to convert certain non-quantifiable values into numerical data. A 100-mm line is marked with two extreme descriptions of the parameter being evaluated at each end. Patients are asked to indicate their current state on the line by drawing a mark, placing a dot, or pointing to a specific location. For example, in the case of pain, one end of the line might read "no pain at all," and the other end "worst imaginable pain." The patient marks the point on the line that best represents their current pain level. The distance from the "no pain" end to the point marked by the patient represents the intensity of the pain they are experiencing. The length of the line between these two points serves as a measure of the patient's subjective experience.

  day 1

Secondary Outcomes (1)

• the State-Trait Anxiety Inventory (STAI)

  day 1

Study Arms (2)

control group

NO INTERVENTION

Participants in this group will not undergo VR glasses application during transradial coronary angiography.

VR Glass Group

ACTIVE COMPARATOR

Participants in this group will use VR glasses during transradial coronary angiography. With the help of VR glasses, patients will be shown visuals based on nature and listen to calming sounds.

Device: wearing VR glass

Interventions

wearing VR glass DEVICE

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.

VR Glass Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indicated for coronary angiography via the transradial approach for reasons other than Acute Coronary Syndrome.
• Patients with no prior history of coronary angiography
• Patients aged 18 years and older
• Patients who are conscious, oriented, cooperative, and able to read and understand Turkish.
• Patients without any physical issues that would prevent the use of virtual reality glasses.
• Patients with no known malignancy, neuropsychiatric disorders, or diagnosed anxiety disorders.
• Patients who agree to participate in the study and sign the "Informed Consent Form" will be included.

You may not qualify if:

• Patients indicated for coronary angiography due to Acute Coronary Syndrome,
• Patients undergoing coronary angiography via an approach other than the transradial route,
• Patients under the age of 18,
• Patients who are unconscious, disoriented, or uncooperative,
• Patients who cannot read or understand Turkish,
• Patients with physical issues preventing the use of virtual reality glasses,
• Patients with known neuropsychiatric disorders, diagnosed anxiety disorders, or those receiving antidepressant or anxiolytic treatment,
• Patients with malignancy,
• Patients who do not agree to participate or who do not sign the "Informed Consent Form" will be excluded.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University Faculty of Medicine

Mersin, Yenisehir, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• ahmet b KECECI, Research Assistant

  Mersin University faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmet B KECECI, Research Assistant

CONTACT

+90 554 557 1249; aburakkececi@gmail.com

Emrah YEŞİL, specialist doctor

CONTACT

+90 505 654 12 73; emrhyesil@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher doctor

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 10, 2024
• Study Start: December 10, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

TU (1)