Efficacy of Music on Reduction of Sedative Drugs in Mechanically Ventilated Intensive Care Unit Patients (MUSIC)
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 10, 2009 | ||||||||
| Last Updated Date | April 20, 2009 | ||||||||
| Start Date ICMJE | December 2008 | ||||||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
sedative drug consumption in mechanically ventilated ICU patients [ Time Frame: 3 days ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00880035 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
stress neuropeptide blood content evolution with MUSIC listening [ Time Frame: 3 days ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy of Music on Reduction of Sedative Drugs in Mechanically Ventilated Intensive Care Unit Patients | ||||||||
| Official Title ICMJE | M.U.S.I.C (MUSicotherapy in the Intensive Care) Interventional, Pilot, Cross-Over, in Mechanically-Ventilated Patients on ICU Ward | ||||||||
| 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:
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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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) |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | December 2010 | ||||||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00880035 | ||||||||
| Other Study ID Numbers ICMJE | 08-105-R2, CRC-PAFI-09 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Olivier Lesur (PI) (Catherine St-Pierre co-PI), CRC-CHUS | ||||||||
| Study Sponsor ICMJE | Universitaire de Sherbrooke | ||||||||
| Collaborators ICMJE | Centre de Recherche Clinique CHUS | ||||||||
| Investigators ICMJE |
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| Information Provided By | Universitaire de Sherbrooke | ||||||||
| Verification Date | April 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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