Music Medicine in Coronary Interventional Cardiology Procedures

NCT07786961 | Not Yet Recruiting

• 1 other identifier: AOSassari_MM
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is: to evaluate the effectiveness of a personalized Music Medicine intervention in patients undergoing invasive coronary interventional cardiology procedures. The study will compare patients who listen to a personalized music playlist through wireless earphones throughout the procedure with patients receiving standard care without music. The primary objective is to assess whether Music Medicine reduces state anxiety, measured using the State-Trait Anxiety Inventory (STAI-Y1). Secondary objectives are to evaluate its effects on access-site crossover, procedural pain, blood pressure, heart rate, and oxygen saturation. The study will also assess adverse reactions, withdrawals, patient satisfaction with the intervention, and, in the Music Medicine group, patients' perceived experience through a semi-structured qualitative interview. The study is designed as a prospective, single-center, open-label, randomized controlled trial with two parallel groups and a 1:1 allocation ratio, enrolling 208 participants. The question the study is trying to answer is: whether listening to a personalized music playlist during an invasive coronary interventional cardiology procedure, in addition to standard care, reduces state anxiety compared with standard care alone, and whether it also improves other relevant procedural outcomes, including pain, the need for access-site crossover, blood pressure, heart rate, and oxygen saturation, without interfering with routine clinical care

Conditions

Acute Coronary Syndrome

Keywords

Music Medicine; Acute Coronary Syndrome; Percutaneous Coronary Intervention; Coronary Angiography

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in State Anxiety Score Assessed by the State-Trait Anxiety Inventory (STAI-Y1)

  State anxiety will be assessed using the State-Trait Anxiety Inventory, State subscale (STAI-Y1). The STAI-Y1 consists of 20 items rated on a 4-point Likert scale. The total score ranges from 20 to 80, with higher scores indicating greater state anxiety. The outcome will be expressed as the mean change in STAI-Y1 total score from baseline to immediately after the coronary interventional cardiology procedure.

  At baseline immediately before the procedure and immediately after completion of the procedure, up to 120 minutes

Secondary Outcomes (8)

• Number of Participants Requiring Access-Site Crossover During the Coronary Interventional Cardiology Procedure

  During the coronary interventional cardiology procedure, up to 120 minutes

• Mean Procedural Pain Score Assessed by the Visual Analog Scale (VAS)

  immediately after the cardiology procedure, up to 120 minutes

• Mean Change From Baseline in Heart Rate

  At baseline immediately before the procedure and immediately after completion of the procedure, up to 120 minutes

• Number of Participants With Adverse Reactions

  Immediately after the cardiology procedure,up to 120 minutes

• Number of Participants Who Withdraw From the Study

  From enrollment through completion of the post-procedure assessment, up to 1 day

Study Arms (2)

Music Medicine arm

EXPERIMENTAL

Patients randomly allocated to the intervention group will listen to a personalized music playlist throughout the entire invasive cardiac procedure. The personalized playlist will be prepared as follows: a) On the day before the procedure, a healthcare professional trained in Music Medicine and in the study protocol will ask the patient which music they would like to listen to during the cardiac procedure. The healthcare professional will explain that the selected music should have characteristics associated with relaxation, calmness, and personal enjoyment, with the aim of reducing anxiety and pain. The patient will listen to the playlist through wireless earphones. b) The healthcare professional will prepare the playlist in the sequence selected by the patient and password-protect it on an MP3 device connected to Spotify. c) Before the procedure begins, a healthcare professional trained in Music Medicine and in the study protocol will place the earphones on the patient, access th

Other: Music Medicine intervention

Standard Care Arm

NO INTERVENTION

Patients randomized to the control group will undergo the coronary cardiac procedure according to the standard clinical care routinely provided in the Cardiac Catheterization Laboratory of the University Hospital of Sassari (AOU Sassari). Standard care will include the usual preparation of the patient for the procedure, clinical and vital-sign monitoring, nursing and medical care throughout the procedure, and administration of pharmacological therapies, including analgesics and/or sedatives when clinically indicated, according to the operator's judgment and current clinical practice. The arterial access site, technical aspects of the procedure, and any additional treatment will be determined exclusively on the basis of the patient's clinical condition and routine care procedures. During the procedure, patients in the standard-care group will not use earphones and will not listen to either a personalized music playlist or any other music.

Interventions

Music Medicine intervention OTHER

The patient will listen to selected music with characteristics associated with relaxation, calmness, and personal enjoyment, with the aim of reducing anxiety and pain. A healthcare professional will prepare the playlist in the sequence selected by the patient and password-protect it on an MP3 device connected to Spotify. The patient will listen to the playlist through wireless earphones throughout the coronary interventional cardiology procedure.

Also known as: Music Therapy

Music Medicine arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>18 years;
• provision of written informed consent and ability to understand the informed consent form.

You may not qualify if:

• patients with ST-segment elevation myocardial infarction (STEMI);
• patients with very-high-risk non-ST-segment elevation myocardial infarction (NSTEMI), as classified according to the 2023 European Society of Cardiology (ESC) Guidelines;
• patients in cardiogenic shock;
• presence of hearing impairment or deafness, assessed through clinical history;
• patients unable to express their musical preferences;
• patients with resuscitated cardiac arrest;
• use of antipsychotic medications, assessed through clinical history;
• history of epilepsy, assessed through clinical history.

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria di Sassari: lead

Study Sites (1)

SS Annunziata Hospital, Sassari

Sassari, Sardinia, 07100, Italy

Location

Related Publications (10)

• Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for the State-Trait Anxiety Inventory (Form Y). Consulting Psychologists Press.

  BACKGROUND

• Pedrabissi, L., & Santinello, M. (1989). Inventario per l'ansia di "stato" e di "tratto": Nuova versione italiana dello STAI, forma Y: Manuale. Organizzazioni Speciali.

  BACKGROUND

• Kokalj Palandačić, A., Učman, S., Novak Šarotar, B., & Lainščak, M. (2023). The manifestation of anxiety in patients undergoing elective coronary angiography. European Psychiatry, 66(S1), S69. https://doi.org/10.1192/j.eurpsy.2023.233

  BACKGROUND

• Weeks BP, Nilsson U. Music interventions in patients during coronary angiographic procedures: a randomized controlled study of the effect on patients' anxiety and well-being. Eur J Cardiovasc Nurs. 2011 Jun;10(2):88-93. doi: 10.1016/j.ejcnurse.2010.07.002. Epub 2010 Aug 3.

  PMID: 20685168 BACKGROUND

• Wang YR, Hung YY, Lu SF. Effect of music-based interventions on anxiety and stress-related vital signs in patients undergoing cardiac catheterization: A systematic review and meta-analysis. Complement Ther Med. 2024 Oct;85:103078. doi: 10.1016/j.ctim.2024.103078. Epub 2024 Aug 28.

  PMID: 39209008 BACKGROUND

• Su SF, Yeh WT. Music Interventions in Percutaneous Coronary Procedures: A Meta-Analysis. Clin Nurs Res. 2021 Feb;30(2):135-145. doi: 10.1177/1054773819883171. Epub 2019 Oct 18.

  PMID: 31625397 BACKGROUND

• Moon JR, Song J, Huh J, Kang IS, Kim JH, Park SW, Chang SA. The effects of music intervention on anxiety and stress responses in adults with CHD undergoing cardiac catheterisation. Cardiol Young. 2023 Feb;33(2):213-220. doi: 10.1017/S1047951122000439. Epub 2022 Mar 14.

  PMID: 35285439 BACKGROUND

• Micheluzzi V, Burrai F, Casula M, Serra G, Al Omary S, Merella P, Casu G. Effectiveness of virtual reality on pain and anxiety in patients undergoing cardiac procedures: A systematic review and meta-analysis of randomized controlled trials. Curr Probl Cardiol. 2024 May;49(5):102532. doi: 10.1016/j.cpcardiol.2024.102532. Epub 2024 Mar 19.

  PMID: 38503359 BACKGROUND

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

  PMID: 22588748 BACKGROUND

• Bradt J, Dileo C, Potvin N. Music for stress and anxiety reduction in coronary heart disease patients. Cochrane Database Syst Rev. 2013 Dec 28;2013(12):CD006577. doi: 10.1002/14651858.CD006577.pub3.

  PMID: 24374731 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Valentina Micheluzzi, PhD

CONTACT

+39 3401753630; valentina.micheluzzi@aousassari.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

IT (1)