The Effect of Music on Anxiety and Vasospasm in Patients Undergoing Transradial Angiography

NCT06800118 | Recruiting

• 1 other identifier: MersinU-HEM-NY-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Radial Artery Spasm; Anxiety; Music Therapy

Keywords

Radial artery spasm; anxiety; music therapy

Outcome Measures

Primary 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.

  day 1

Study Arms (2)

intervention group

ACTIVE COMPARATOR

In addition to standard care, patients in the intervention group will listen to music through headphones at a volume adjusted to their preference. The selected music will feature Classical Turkish Music performed on the ney in the Hüseyni maqam, which has been shown in previous studies to promote relaxation.

Device: Music intervention

control group

NO INTERVENTION

Patients in the control group will receive standard care, including obtaining informed consent, recording medical history, establishing venous access, measuring vital signs, and performing an ECG. After the procedure, the wrist sheath will be removed, bleeding control will be performed, and the wrist will be dressed with a pressure bandage. Patients without percutaneous coronary intervention will be discharged 6 hours post-procedure, while those with percutaneous coronary intervention will remain under observation for one day.

Interventions

Music intervention DEVICE

Music will be played for patients undergoing coronary angiography, and vasospasm and pain levels will be evaluated.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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."

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin Universiy Faculty of Nursing

Mersin, yenisehir, 33343, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Nida YESİL, Graduate Nursing Student

  Mersin University Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nida YESIL, Graduate Nursing Student

CONTACT

+90 544 451 1423; nidaaykusyesil@gmail.com

Emrah YESİL, specialist doctor

CONTACT

+90 505 654 12 73; emrhyesil@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Nursing Student

Model Details: Music will be played for the patients in this group during transradial coronary angiography.

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 29, 2025
• Study Start: October 10, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 20, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

TU (1)