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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Université de Sherbrooke.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Centre de Recherche Clinique CHUS
Information provided by:
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00880035
First received: April 10, 2009
Last updated: April 20, 2009
Last verified: April 2009

April 10, 2009
April 20, 2009
December 2008
July 2010   (final data collection date for primary outcome measure)
sedative drug consumption in mechanically ventilated ICU patients [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00880035 on ClinicalTrials.gov Archive Site
stress neuropeptide blood content evolution with MUSIC listening [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Sedative Drug Consumption
  • Mechanically Ventilated ICU Patients
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 A
    Group A: day 1 = music, day 2 = washout, day 3 = headphone without music
    Intervention: Device: MP3 music program listening
  • Experimental: Group B
    Group B: day 1 = headphone without music, day 2 = washout, day 3 = music
    Intervention: Device: MP3 music program listening
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Olivier Lesur, MD (819)346-1110 olivier.lesur@usherbrooke.ca
Contact: Catherine St-Pierre, MD (819)346-1110 catherine.st-pierre@usherbrooke.ca
Canada
 
NCT00880035
08-105-R2, CRC-PAFI-09
Yes
Olivier Lesur (PI) (Catherine St-Pierre co-PI), CRC-CHUS
Université de Sherbrooke
Centre de Recherche Clinique CHUS
Principal Investigator: Olivier Lesur, MD CHUS and Université de Sherbrooke
Université de Sherbrooke
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP