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Generalized Versus Personalized Music Therapy in the ICU to Reduce Sedation

NCT03280329 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2018-06-26

No results posted yet for this study

Summary

Admission to an Intensive Care Unit (ICU) is one of the major causes of stress and both physical and emotional difficulties for critically ill patients, both because of the illness that caused the admission and of the ICU nevironment itself. Despite the use of protocols and tools to evaluate sedation, many patients continue to have high levels of anxiety. An inadequate treatment of this condition is associated with increased sympathetic activity which causes dyspnea and an increase in myocardial oxygen consumption. Sedative drugs, on the other side, may have significant side effects.

In view of this, there is clear need to find new strategies and instruments allowing for the maximization of critical patients' comfort, by promoting pain, anxiety, stress and agitation relief and minimising the need of sedative therapy.

The main hypothesis of this study is that the use of music therapy for critically ill patients can lead to a significant increase of the days free from neuroactive therapy (analgesics, sedatives, antianxiety meds, antipsychotics) in the first 28 days following Intensive Care Unit admission. To this purpose, data obtained from 3 groups of patients will be compared - a group with individual treatment administered by a music therapist and delivered by headphones, a group with a generalised treatment, through the creation of a weekly musical program continuously broadcasted in the hospital room, and a control group.

Conditions

  • Critical Illness
  • Hypnotics and Sedatives
  • Music Therapy

Interventions

OTHER

Generalized Music therapy

Patients will receive broadcasted music via speakers in their room from 7am to 11pm, from admission to discharge

OTHER

Personalized Music therapy

Patients will receive music via earphones after specific music therapist advice, for 2 hours per day, from admission to discharge

Sponsors & Collaborators

  • University of Milan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2018-10-01
Completion
2018-12-01

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 NCT03280329 on ClinicalTrials.gov