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

Study Overview
=================
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: Impact on sedative drug consumption. 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.

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.

Official Title
-----------------
M.U.S.I.C (MUSicotherapy in the Intensive Care) Interventional, Pilot, Cross-Over, in Mechanically-Ventilated Patients on ICU Ward

Conditions
-----------------
Sedative Drug Consumption, Mechanically Ventilated ICU Patients

Intervention / Treatment
-----------------
* Device: MP3 music program listening


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Group A: day 1 = music, day 2 = washout, day 3 = headphone without music | Device: MP3 music program listening<br>* 3 days with two 1 hour periods of headset music listening (1 day on, 1 day wash-out, 1 day off)<br>|
| Experimental: Group B<br>Group B: day 1 = headphone without music, day 2 = washout, day 3 = music | Device: MP3 music program listening<br>* 3 days with two 1 hour periods of headset music listening (1 day on, 1 day wash-out, 1 day off)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sedative drug consumption in mechanically ventilated ICU patients |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stress neuropeptide blood content evolution with MUSIC listening |  | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sedative drug, stress, music, mechanical ventilation, IL-6, cortisol, prolactin, CRP, copeptin