Recruiting
Phase 2
Phase 3

Music

Sponsor:

Université de Sherbrooke

Code:

NCT00880035

Conditions

Sedative Drug Consumption

Mechanically Ventilated ICU Patients

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MP3 music program listening

Study Details

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.

Conditions

Sedative Drug Consumption

Mechanically Ventilated ICU Patients

Study ID

NCT00880035

Start date

Dec, 2008

Status verified date

Apr, 2009

Completion date

Dec, 2010

Anticipated

Primary completion date

Jul, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A

Group A: day 1 = music, day 2 = washout, day 3 = headphone without music

experimental: Group B

Group B: day 1 = headphone without music, day 2 = washout, day 3 = music

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Olivier Lesur, MD

(819)346-1110olivier.lesur@usherbrooke.ca

Catherine St-Pierre, MD

(819)346-1110catherine.st-pierre@usherbrooke.ca

Locations

CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

More Information

Sponsor

Université de Sherbrooke

Last update posted

Apr 22, 2009

Last verified

Apr, 2009

Keywords

  • sedative drug
  • stress
  • music
  • mechanical ventilation
  • IL-6
  • cortisol
  • prolactin
  • CRP
  • copeptin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2009-04-22.