Radial Artery SpasmNCT06726031
The Effect of Using Virtual Reality Glasses on Anxiety-related Radial Vasospasm in Patients Undergoing Transradial Coronary Angiography
A study testing wearing VR glass in people with Radial Artery Spasm and Radial Artery Access, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radial Artery Spasm, Radial Artery Access, Virtual Reality
- What is being tested?
- wearing VR glass
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Mersin University Faculty of Medicine
Mersin, Yenisehir, 33343
ahmet b kececi, Research Assistant, +90 554 557 1249, aburakkececi@gmail.com
ahmet b kececi, Research Assistant
About this study
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.
Read more
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
- Being tested
- wearing VR glass
- Keywords
- radial artery spasm, virtual reality, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearing VR glassDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: wearing VR glass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1
Secondary outcomes (1)
the State-Trait Anxiety Inventory (STAI)
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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start10 Dec 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery SpasmStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Burak KECECİ, Mersin University
- Investigators
- ahmet b KECECI, Research Assistant, Principal investigator, Mersin University faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726031
- Sponsor's protocol ID
- MersinU-CAR-ABK-01
- Status last verified
- Dec 2024
- First submitted
- 29 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Virtual Reality Glasses on Anxiety-related Radial Vasospasm in Patients Undergoing Transradial Coronary Angiography
- ClinicalTrials.gov ID
- NCT06726031
- Acronym / sponsor ID
- MersinU-CAR-ABK-01
- Conditions
- Radial Artery Spasm, Radial Artery Access, Virtual Reality
- Keywords
- radial artery spasm, virtual reality, anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Participants in this group will not undergo VR glasses application during transradial coronary angiography. |
| VR Glass Group | Active comparator | Device: wearing VR glassParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wearing VR glassThe 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. | Device | VR Glass Group |
Primary outcome
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.
1 secondary outcome
the State-Trait Anxiety Inventory (STAI)
Time frame: day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Radial Artery Spasm
RecruitingObservational study
Radial Access Data in Vascular Interventions Registry
Radial Artery Occlusion, Radial Artery Spasm
Not yet recruiting
Impact of Preprocedural Stress Ball Use on Radial Artery Outcomes in Elective Coronary Angiography
Coronary Arterial Disease (CAD), Radial Artery Spasm
Recruiting
The Effect of Music on Anxiety and Vasospasm in Patients Undergoing Transradial Angiography
Radial Artery Spasm, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ahmet b KECECI, Research Assistant principal investigator
Mersin University faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wearing VR glass in people with Radial Artery Spasm and Radial Artery Access, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmet B KECECI, Research Assistant (+90 554 557 1249, aburakkececi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Visual Analog Scale (VAS) (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.