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Efficacy of Music on Reduction of Sedative Drugs in Mechanically Ventilated Intensive Care Unit Patients

M.U.S.I.C (MUSicotherapy in the Intensive Care) Interventional, Pilot, Cross-Over, in Mechanically-Ventilated Patients on ICU Ward

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00880035
Acronym
MUSIC
Enrollment
50
Registered
2009-04-13
Start date
2008-12-31
Completion date
2010-12-31
Last updated
2009-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanically Ventilated ICU Patients, Sedative Drug Consumption

Keywords

sedative drug, stress, music, mechanical ventilation, IL-6, cortisol, prolactin, CRP, copeptin

Brief summary

Major objective: a three-days interventional cross-over trial \[one day music on, one day wash-out, one day music off\]\[two periods of listening/day\], to evaluate: 1. Impact on sedative drug consumption. 2. Alteration of stress neuropeptide blood concentrations. Population: mechanically-ventilated ICU patients The investigators hypothesize the music will decrease the need of sedative drugs and reduce the concentration of neuropeptides in circulation.

Detailed description

The study will imply patients mechanically ventilated for more than 3 days, that require sedation with benzodiazepine and narcotics. There will be two groups both of exposed to music and placebo (headphones without music). The study will be simple blind. Sedation scale will be followed regularly. Vitals signs and adjustment of sedation will be recorded by the nurse on the ward. Blood test will be taken before and after placement of headphones in the morning. We will measure IL-6, cortisol, copeptin, prolactin, CRP. We will analyse the total reduction dose of sedation and analgesia on a daily basis. We will consider a fall of 20% of medication to be significative.

Interventions

DEVICEMP3 music program listening

3 days with two 1 hour periods of headset music listening (1 day on, 1 day wash-out, 1 day off)

Sponsors

Centre de Recherche Clinique CHUS
CollaboratorUNKNOWN
Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adults older than 18 years old * expected time of mechanical ventilation of more than 72 hours * sedation needs for a scale of Sedation-Agitation Scale (SAS) more than 1

Exclusion criteria

* hearing impairment * pregnancy * needs of vasopressin * needs of curarisation

Design outcomes

Primary

MeasureTime frame
sedative drug consumption in mechanically ventilated ICU patients3 days

Secondary

MeasureTime frame
stress neuropeptide blood content evolution with MUSIC listening3 days

Countries

Canada

Contacts

Primary ContactOlivier Lesur, MD
olivier.lesur@usherbrooke.ca(819)346-1110
Backup ContactCatherine St-Pierre, MD
catherine.st-pierre@usherbrooke.ca(819)346-1110

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026