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

Université de Sherbrooke

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Mechanically Ventilated ICU Patients; Sedative Drug Consumption

Treatments: Device: MP3 music program listening

Study type: Interventional

Funder types: Other

Identifiers

NCT00880035

CRC-PAFI-09

08-105-R2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Device: MP3 music program listening

Group B

Experimental group

Description:

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

Treatment:

Device: MP3 music program listening