What is the clinical evidence from this study?

Study design: RCT. Population: Pain during mediastinal drain removal after myocardial revascularization (n=52). Intervention: Combined music and cryotherapy vs. Standard care. Primary outcome: Reduction in pain intensity measured by the Numerical Rating Scale (NRS).

What question did this study set out to answer?

To evaluate the efficacy of combined music and cryotherapy on pain relief during mediastinal drain removal in myocardial revascularization patients.

May 8, 2026

Efficacy of Combined Music and Cryotherapy for Pain Relief During Mediastinal Drain Removal After Myocardial Revascularization: A Randomized Clinical Trial Protocol

Key Result

This protocol describes a randomized clinical trial of 52 patients to evaluate whether combined music and cryotherapy reduces pain intensity during mediastinal drain removal after CABG.

Key Points

To evaluate the efficacy of combined music and cryotherapy on pain relief during mediastinal drain removal in myocardial revascularization patients.
Randomized clinical trial following SPIRIT and CONSORT guidelines.
Involves 52 participants randomly allocated to experimental (music and cryotherapy) or control (standard care) groups.
Primary outcome measured is pain intensity using the Numerical Rating Scale (NRS).
Expected reduction in pain intensity during mediastinal drain removal in the experimental group compared to control.
Feasibility confirmed through a pilot test with initial participants.

Study Design

Type

RCT (n=52)

Randomization

randomly allocated

Multicenter

Structured PICO

Does combined music and cryotherapy reduce pain intensity during mediastinal drain removal in patients undergoing myocardial revascularization surgery?

Population

52 adults (age ≥18 years) undergoing myocardial revascularization surgery (CABG) with postoperative hemodynamic stability, Glasgow Coma Scale 15, and a mediastinal drain scheduled for removal.

Intervention

Combined music-based intervention and cryotherapy during mediastinal drain removal

Comparator

Institution's standard care

Outcome

Reduction in pain intensity, measured by the Numerical Rating Scale (NRS)patient reported

This is a protocol for a randomized clinical trial evaluating the efficacy of music and cryotherapy for pain relief during mediastinal drain removal post-CABG.

Abstract

Introduction Coronary artery bypass grafting (CABG) is a procedure that requires the use of a mediastinal drain to prevent blood accumulation around the heart. Removal of this device is recognized as a painful experience for the patient. In this context, the adoption of cost-effective, non-pharmacological pain management strategies is essential to reduce adverse effects and minimize opioid exposure. Among these strategies, music-based intervention and cryotherapy emerge as promising interventions, supported by scientific evidence indicating their efficacy in reducing pain and anxiety. Objective To evaluate the efficacy of the combined use of music and cryotherapy in alleviating pain during mediastinal drain removal in patients undergoing myocardial revascularization surgery. Methodology This is a randomized clinical trial, developed in accordance with the SPIRIT and CONSORT guidelines. The primary outcome of the study is the reduction in pain intensity, as measured by the established Numerical Rating Scale (NRS). The study will be conducted in the Intensive Care Unit of the Heart Hospital of Natal, involving two groups: the experimental group, which will receive the music-based intervention and cryotherapy, and the control group, which will follow the institution’s standard care. The sample will consist of 52 randomly allocated participants, and feasibility will be evaluated through a pilot test with the first five. Eligibility criteria include: age ≥18 years, postoperative hemodynamic stability, a score of 15 on the Glasgow Coma Scale, ability to understand and respond to pain assessment instruments, and the presence of a mediastinal drain scheduled for removal. Conclusion This study aims to contribute new evidence regarding integrative and complementary health practices, thereby optimizing the comprehensive care delivered to patients post-myocardial revascularization. Registration This study is registered on the Brazilian Registry of Clinical Trials (ReBEC) platform under the number RBR-2nzh9vr and was approved by the Research Ethics Committee of the Federal University of Rio Grande do Norte (Opinion no. 83976124.0.0000.5537).

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