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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 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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • sedative drug consumption in mechanically ventilated ICU patients [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • stress neuropeptide blood content evolution with MUSIC listening [ Time Frame: 3 days ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 10, 2009
Last Updated: April 20, 2009
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on November 25, 2014