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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Université de Sherbrooke.
Recruitment status was:  Recruiting
Centre de Recherche Clinique CHUS
Information provided by:
Université de Sherbrooke Identifier:
First received: April 10, 2009
Last updated: April 20, 2009
Last verified: April 2009

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.

Condition Intervention Phase
Sedative Drug Consumption Mechanically Ventilated ICU Patients Device: MP3 music program listening Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: M.U.S.I.C (MUSicotherapy in the Intensive Care) Interventional, Pilot, Cross-Over, in Mechanically-Ventilated Patients on ICU Ward

Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • sedative drug consumption in mechanically ventilated ICU patients [ Time Frame: 3 days ]

Secondary Outcome Measures:
  • stress neuropeptide blood content evolution with MUSIC listening [ Time Frame: 3 days ]

Estimated Enrollment: 50
Study Start Date: December 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Group A: day 1 = music, day 2 = washout, day 3 = headphone without 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)
Experimental: Group B
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)

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00880035

Contact: Olivier Lesur, MD (819)346-1110
Contact: Catherine St-Pierre, MD (819)346-1110

Canada, Quebec
CHUS Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Centre de Recherche Clinique CHUS
Principal Investigator: Olivier Lesur, MD CHUS and Université de Sherbrooke
  More Information

Responsible Party: Olivier Lesur (PI) (Catherine St-Pierre co-PI), CRC-CHUS Identifier: NCT00880035     History of Changes
Other Study ID Numbers: 08-105-R2
Study First Received: April 10, 2009
Last Updated: April 20, 2009

Keywords provided by Université de Sherbrooke:
sedative drug
mechanical ventilation

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on September 20, 2017