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

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ClinicalTrials.gov Identifier: NCT00880035
Recruitment Status : Unknown
Verified April 2009 by Université de Sherbrooke.
Recruitment status was:  Recruiting
First Posted : April 13, 2009
Last Update Posted : April 22, 2009
Sponsor:
Collaborator:
Centre de Recherche Clinique CHUS
Information provided by:
Université de Sherbrooke

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.


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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : December 2008
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : December 2010

Arm Intervention/treatment
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)




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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880035


Contacts
Contact: Olivier Lesur, MD (819)346-1110 olivier.lesur@usherbrooke.ca
Contact: Catherine St-Pierre, MD (819)346-1110 catherine.st-pierre@usherbrooke.ca

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

Responsible Party: Olivier Lesur (PI) (Catherine St-Pierre co-PI), CRC-CHUS
ClinicalTrials.gov Identifier: NCT00880035     History of Changes
Other Study ID Numbers: 08-105-R2
CRC-PAFI-09
First Posted: April 13, 2009    Key Record Dates
Last Update Posted: April 22, 2009
Last Verified: April 2009

Keywords provided by Université de Sherbrooke:
sedative drug
stress
music
mechanical ventilation
IL-6
cortisol
prolactin
CRP
copeptin

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs