The Effect of Using Virtual Reality Glasses on Anxiety-related Radial Vasospasm in Patients Undergoing Transradial Coronary Angiography
NCT ID: NCT06726031
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2024-12-10
2025-04-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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control group
Participants in this group will not undergo VR glasses application during transradial coronary angiography.
No interventions assigned to this group
VR Glass Group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
Yes
Sponsors
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Mersin University
OTHER
Responsible Party
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Ahmet Burak KECECİ
researcher doctor
Principal Investigators
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ahmet b KECECI, Research Assistant
Role: PRINCIPAL_INVESTIGATOR
Mersin University faculty of medicine
Locations
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Mersin University Faculty of Medicine
Mersin, Yenisehir, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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ahmet b kececi, Research Assistant
Role: primary
Other Identifiers
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MersinU-CAR-ABK-01
Identifier Type: -
Identifier Source: org_study_id