NCT06800118 The Effect of Music on Anxiety and Vasospasm in Patients Undergoing Transradial Angiography
| NCT ID | NCT06800118 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mersin University |
| Condition | Radial Artery Spasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-10-10 |
| Primary Completion | 2025-04-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-10-10 with a primary completion date of 2025-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cardiovascular diseases are among the most significant health issues threatening human well-being, representing the leading cause of mortality and morbidity worldwide and in our country among non-communicable diseases. In Turkey, 33.4% of deaths are attributed to circulatory system diseases and ischemic heart diseases, with coronary artery disease (CAD) being the most common cause. The most frequently applied and accurate invasive diagnostic method for diagnosing CAD is coronary angiography. Coronary angiography, still regarded as the gold standard today, is a diagnostic procedure that visualizes the heart's blood vessels using contrast media. This procedure can be performed via the femoral, brachial, radial, or axillary arteries. In the past, coronary interventional procedures were commonly performed through the femoral artery. However, following the 2017 European Society of Cardiology (ESC) guidelines on ST-segment elevation myocardial infarction (STEMI) management, the radial artery has become the preferred route due to its lower risk of bleeding and shorter hospital stays. Coronary angiography is performed in a sterile environment while the patient is awake. Due to its invasive nature and the involvement of a vital organ, coronary angiography can evoke anxiety and fear of death in patients. Factors contributing to this include uncertainty about the procedure, unfamiliarity with the environment, communication with unknown personnel, exposure to medical terminology, and unusual sounds in the procedure room. The radial artery is more prone to vasospasm than other vessels used in coronary angiography, due to its smaller diameter and rich smooth muscle content. Local anesthesia is administered at the access site to reduce pain during radial artery interventions. Additionally, anticoagulant and vasodilatory drugs are used to prevent procedure-related vasospasms and thrombotic events. Despite these preventive measures, vasospasm is observed in 4-20% of patients undergoing transradial coronary angiography. Anxiety experienced by patients during the procedure can also contribute to vasospasm in the radial artery. Various invasive and non-invasive interventions, such as listening to music, acupressure, and massage, are frequently employed to reduce patient anxiety. Among these non-invasive methods, providing music during the procedure has gained prominence. Music helps divert patients' attention, enabling them to distance themselves from pain, fear, stress, and anxiety.
Eligibility Criteria
Inclusion Criteria: * Indication for radial coronary angiography (CA) due to non-acute coronary syndrome (ACS) reasons * Undergoing coronary angiography for the first time * Aged 18 years or older * Conscious, oriented, and cooperative * Able to read and understand Turkish * Willing to participate in the study * Without any physical limitations preventing music listening * Without a diagnosis of hearing loss * Not using a hearing aid * Without a diagnosis of anxiety disorder * Without any mental health disorders * Having signed the "Voluntary Informed Consent Form. Exclusion Criteria: * Indication for radial coronary angiography (CA) due to acute coronary syndrome (ACS) * Previous history of coronary angiography * Under the age of 18, * Unconscious, disoriented, or uncooperative, * Unable to read or understand Turkish, * Unwilling to participate in the study, * Having physical limitations that prevent listening to music, * Diagnosed with hearing loss, * Using a hearing aid, * Diagnosed with an anxiety disorder or taking medication for anxiety, * Having a mental health disorder, * Not signing the "Voluntary Informed Consent Form."
Contact & Investigator
Nida YESİL, Graduate Nursing Student
PRINCIPAL INVESTIGATOR
Mersin University Faculty of Nursing
Frequently Asked Questions
Who can join the NCT06800118 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Radial Artery Spasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06800118 currently recruiting?
Yes, NCT06800118 is actively recruiting participants. Contact the research team at nidaaykusyesil@gmail.com for enrollment information.
Where is the NCT06800118 trial being conducted?
This trial is being conducted at Mersin, Turkey (Türkiye).
Who is sponsoring the NCT06800118 clinical trial?
NCT06800118 is sponsored by Mersin University. The principal investigator is Nida YESİL, Graduate Nursing Student at Mersin University Faculty of Nursing. The trial plans to enroll 90 participants.