Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT00880035
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.
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.
Study:
NCT00880035
Study Brief:
Protocol Section:
NCT00880035