Clinical trial NCT06726031: The Effect of Using Virtual Reality Glasses on Anxiety-related Radial Vasospasm in Patients Undergoing Transradial Coronary Angiography
Official title: The Effect of Using Virtual Reality Glasses on Anxiety-related Radial Vasospasm in Patients Undergoing Transradial Coronary Angiography
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Radial Artery Spasm
Radial Artery Access
Virtual Reality
Keywords: radial artery spasm
virtual reality
anxiety
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: the Visual Analog Scale (VAS)
timeFrame: day 1
Secondary outcomes:
measure: the State-Trait Anxiety Inventory (STAI)
timeFrame: day 1
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University Faculty of Medicine
state: Yenisehir
Study officials:
affiliation: Mersin University faculty of medicine
name: ahmet b KECECI, Research Assistant
role: PRINCIPAL_INVESTIGATOR
References: