Music-induced analgesia for adults and older adults during femoral arterial sheath removal after cardiac catheterization: a randomized clinical trial protocol

BACKGROUND: Cardiovascular diseases cause the death of 17.5 million people every year. Cardiac catheterization is an invasive diagnostic exam that allows treatment followed by the examination and can cause some complications such as pain. From this perspective, music has alleviated suffering and promoted pain relief for patients. This study aims to evaluate the effectiveness of music therapy to relieve pain in adults and older adults during femoral arterial sheath removal after cardiac catheterization. METHODS: This is a randomized controlled clinical trial, with two arms and a single-blind design to be carried out with 68 patients equally allocated into control and experimental groups. The intervention will be applied with the use of headphones without any musical transmission in the control group or with the patient’s musical preference in the experimental group with sound intensity of 60 dB. These patients will be evaluated in three moments: immediately before, during and 15 min after the painful procedure. The primary outcome includes reduction of pain intensity verified by the Visual Analogue Scale and the secondary outcome corresponds to improvement of vital signs and vocal and facial pain expressions. DISCUSSION: This study will allow by testing a non-pharmacological strategy to relieve pain during femoral sheath removal after cardiac catheterization, having its parameters evaluated at three moments: immediately before (30 min), during the procedure and 15 min after the painful procedure. It also enables the use of a low-cost, potentially effective resource that makes nursing care more humanized by improving user satisfaction with the service provided, in addition to reducing the need for post-procedure analgesics. TRIAL REGISTRATION: This study is registered on the Brazilian Clinical Trials Registry (REBEC) platform under number RBR-3t3qwp7 (05/04/2022) and was approved by the Research Ethics Committee of the Federal University of Rio Grande do Norte under CAAE 52,586,521.8.0000.5537 (11/11/2021).