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NCT Number: NCT06726031

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

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.

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Key information

Conditions

Radial Artery Spasm Anxiety Disorders Mental Disorders Radial Artery Access Virtual Reality

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mersin University Faculty of Medicine

Mersin, Yenisehir, 33343, Turkey (Türkiye)

Location contact

ahmet b kececi, Research Assistant

CONTACT

[email protected]

+90 554 557 1249

ahmet b kececi, Research Assistant

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. the Visual Analog Scale (VAS)

    Time frame: day 1

    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.

Secondary outcomes

  1. the State-Trait Anxiety Inventory (STAI)

    Time frame: day 1

    The STAI (State-Trait Anxiety Inventory) is a psychological tool developed to assess individuals' anxiety levels and consists of a total of 40 questions. The scale addresses anxiety in two distinct dimensions: State Anxiety and Trait Anxiety. State anxiety measures the individual's temporary level of anxiety in response to a specific and transient situation, while trait anxiety evaluates the individual's general tendency to experience anxiety and their predisposition to perceive anxiety as a personality trait. Both subscales consist of 20 questions, and individuals are asked to indicate how much the given statements apply to them.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmet B KECECI, Research Assistant

CONTACT

[email protected]

+90 554 557 1249

Emrah YEŞİL, specialist doctor

CONTACT

[email protected]

+90 505 654 12 73

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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