A Phase 2/3 interventional study of MP3 music program listening in Sedative Drug Consumption and Mechanically Ventilated ICU Patients, sponsored by Université de Sherbrooke. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-04-22.
Sponsored by Université de Sherbrooke · Phase 2/3, Interventional, and Treatment
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:
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.
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.
Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group A: day 1 = music, day 2 = washout, day 3 = headphone without music
Device: MP3 music program listening
Group B: day 1 = headphone without music, day 2 = washout, day 3 = music
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)
sedative drug consumption in mechanically ventilated ICU patients
Time frame: 3 days
stress neuropeptide blood content evolution with MUSIC listening
Time frame: 3 days
This study is status unknown, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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Université de Sherbrooke