Generalized Versus Personalized Music Therapy in the ICU to Reduce Sedation

NCT03280329 | Unknown

• 1 other identifier: Musicoterapia
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Neuroactive drug free days

  the outcome will be calculated giving one point for each day during the measurement period that patients are both alive and free the administration of any neuroactive drug

  one year

Secondary Outcomes (2)

• Sedative exposure

  one year

• reduction of the stress associated to ICU stay

  one year

Study Arms (3)

Control

NO INTERVENTION

the patients who belong to this group will not be assigned to a regulated music therapy treatment, thus they will listen to the background sounds (alerts, voices) right in the Intensive Care environment; radio use will be allowed according to medical/ nursing judgements

Personalised treatment

ACTIVE COMPARATOR

A music therapy advice will be performed with each patient (if possible from the neurological point of view) or their caregivers to assess their musical preferences and a list of songs will be generated which will be reproduced for 2 hours per day from admission to discharge with the use of earphones.

Other: Personalized Music therapy

Generalized treatment

ACTIVE COMPARATOR

Music will be broadcasted in each patient room after the creation of a 'weekly playlist' with the following considerations: 1. Daily sound reproduction from 7 am to 11 pm, with 10 minutes break about every 50 minutes of music; 2. Spread through the environment with specifically designated speakers, at a controlled volume (30-50 dB); 3. Choice of playlist of music both classic and modern, with very easy listening, selected according to the daily hours to restore circadian rhythm and following predictable activities of care provided to patients (hygienic care, retail food, administration other therapies, physiotherapy, visit by relatives, …); 4. Mixing tracks so that there is continuity and fluidity of listening

Other: Generalized Music therapy

Interventions

Generalized Music therapy OTHER

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

Generalized treatment

Personalized Music therapy OTHER

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

Personalised treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients hospitalized in Intensive Care for any medical, surgical traumatic condition, whose stay in the ICU is expected to be longer than 2 days

You may not qualify if:

• expected Glascow Goma Scale at ICU discharge lower than 12
• hearing impairment

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Ospedale San Paolo - Polo Universitario

Milan, 20142, Italy

RECRUITING

Related Publications (1)

• Mistraletti G, Solinas A, Del Negro S, Moreschi C, Terzoni S, Ferrara P, Negri K, Calabretta D, Formenti P, Formenti A, Umbrello M. Generalized music therapy to reduce neuroactive drug needs in critically ill patients. Study protocol for a randomized trial. Trials. 2024 Jun 12;25(1):379. doi: 10.1186/s13063-024-08220-8.

  PMID: 38867317 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

michele umbrello, MD

CONTACT

+390281844476; micheleumbrello@yahoo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University researcher

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 12, 2017
• Study Start: May 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

IT (1)