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Music for Surgical Intensive Care (MUSIC)

NCT06657040 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2024-10-24

No results posted yet for this study

Summary

Intensive care units (ICUs) are environments specialized in the care of critically ill patients. Despite significant advances, ICUs are often seen as a dehumanized environment. Among the various stressors in ICUs, anxiety, pain, psychomotor agitation and mental confusion, need for mechanical restraint, lack of privacy, noise, restricted visiting time with family members and excessive lighting stand out. The tripod composed of pain, anxiety and delirium (often associated with the presence of psychomotor agitation, mental confusion and altered level of consciousness) has a high incidence and morbidity. A set of prevention, intensity reduction and treatment measures has been proposed for these conditions, with a growing number of scientific evidence supporting their routine use.

Elderly patients tend to be particularly susceptible to the stressors described above. This aspect represents an additional source of concern for ICUs, since the elderly today represent the majority of patients admitted to ICUs. Hospitalization in ICUs after surgical procedures is often an unknown moment for the individual and, consequently, associated with the development of numerous unpleasant sensations, directly interfering with the patient's recovery.

Music as a therapy tool in medical practice has been used since 1890. After a little more than two decades, in 1914 it was applied in a surgical procedure by physician Evan Kane as a way of "calming patients and diverting attention from fear". associated with combined therapy with local anesthesia. In this context, being a low-cost tool, with minimal adverse effects and high acceptability, the use of music has proven to be a great ally in the arsenal of non-pharmacological therapies for the prevention of delirium, anxiety and pain.

We intend, through a randomized multicenter clinical trial, to investigate whether the use of music as therapy is capable of reducing the incidence of anxiety, pain and delirium in elderly patients undergoing surgical procedures and hospitalized during the postoperative period in intensive care units.

Conditions

  • DELIRIUM

Interventions

OTHER

MUSIC

The intervention group will receive a soundtrack through individual choice of anti-noise headphones. The music offer platform will be provided by an application developed by MusicCare (www.music.care/en/index.html) in two periods of the day (09:00 and 16:00), lasting 45 minutes each, for up to seven postoperative days or until discharge from the unit (whichever occurs first). MusicCare has been widely tested in several countries and there are a large number of publications in anesthesiology, ICU, cardiology and neurology, among other specialties, demonstrating its safety and efficacy69,70. Patients who were hospitalized for more than 48 hours, that is, who received a minimum of 4 intervention periods, will be considered as patients with effective intervention. Patients with less time will be evaluated in the form of intention to treat.

Sponsors & Collaborators

  • D'Or Institute for Research and Education

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2024-11-01
Completion
2025-01-31

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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 NCT06657040 on ClinicalTrials.gov