NCT00880035

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Université de Sherbrooke · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sedative Drug Consumption
• Mechanically Ventilated ICU Patients

Interventions

Type	Name	Description
DEVICE	MP3 music program listening	3 days with two 1 hour periods of headset music listening (1 day on, 1 day wash-out, 1 day off)

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-07-01
• Completion: 2010-12-01
• First posted: 2009-04-13
• Last updated: 2009-04-22

Locations

1 site across 1 country: Canada