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Music Medicine in Coronary Interventional Cardiology Procedures

NCT07786961 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2026-08-26

No results posted yet for this study

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

Interventions

OTHER

Music Medicine intervention

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.

Sponsors & Collaborators

  • Azienda Ospedaliero Universitaria di Sassari

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2029-08-31
Completion
2029-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07786961 on ClinicalTrials.gov