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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sedative Drug Consumption Mechanically Ventilated ICU Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group A

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

Group Type EXPERIMENTAL

MP3 music program listening

Intervention Type DEVICE

3 days with two 1 hour periods of headset music listening (1 day on, 1 day wash-out, 1 day off)

Group B

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

Group Type EXPERIMENTAL

MP3 music program listening

Intervention Type DEVICE

3 days with two 1 hour periods of headset music listening (1 day on, 1 day wash-out, 1 day off)

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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