Music for Surgical Intensive Care (MUSIC)

Not Applicable

Not yet recruiting

• Conditions: DELIRIUM

• Registration Number: NCT06657040
• Lead Sponsor: D'Or Institute for Research and Education

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-10-22
• Last Update Submitted: 2024-10-22
• Study First Posted: 2024-10-24
• Last Update Posted: 2024-10-24
• Study Start: 2024-11-01
• Primary Completion: 2024-11-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Elective surgery admitted to the ICU in the immediate period after the surgical procedure; · Age equal to or greater than 65 years

Exclusion Criteria

• · Moderate to severe dementia, defined by 2 to 3 points in the clinical dementia rating (CDR)66;

  • Impossibility of verbal communication (eg: aphasia);
  • Lack of understanding of the Portuguese language;
  • Inability to listen to music due to hearing impairment or intolerance to the use of headphones;
  • Mechanical ventilation for more than 12 hours;
  • Richmond Agitation Sedation Scale (RASS) less than or equal to 324;
  • Neurosurgical and craniofacial procedures;
  • Refusal or failure to sign the free and informed consent form (TCLE).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
combined frequency of delirium and anxiety	SEVEN DAYS	The primary endpoint is the combined frequency of delirium and anxiety during the first 7 days of ICU stay Assessments will be performed using the form developed for the study, consisting of the CAM-ICU 7, the numeric pain scale (NRS) and the HADS-A scale. Additionally, the form will document the vital signs: systolic blood pressure, diastolic blood pressure and heart rate measured immediately before and after the intervention in the two periods of the day, in addition to data referring to the presence of pain and episodes of psychomotor agitation and/or delirium, as well as the use of analgesics and opioids in the period referring to the 12 hours prior to the application of the intervention. The CAM-ICU7 and NRS tools will be applied twice a day before and after the intervention, as well as the measurement of vital signs, while the HADS-A scale will be applied only once a day in the morning assessment.