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:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT06120660
Brief Summary:
Aim: To evaluate the effects of a musical intervention on serum cortisol, prolactin, interleukin-6 levels and physiological parameters in sedated patients undergoing invasive mechanical ventilation.
Detailed Description:
Design, Setting and Study Subjects: A randomized clinical trial will be conducted in the ICU of a spanish tertiary hospital. The study subjects will be adults, intubated, subjected to invasive mechanical ventilation, arterial catheter undergoing invasive mechanical ventilation, carrying an arterial catheter, with an adequate level of sedation and who do not present pain during the intervention.
Variables: The main variable will be total serum cortisol, prolactin, interleukin-6 levels. Secondary variables: secondary variables will be those used to measure physiological parameters to assess the patient's hemodynamic status of the patient in relation to the intervention.
Data collection: There will be 2 groups: intervention and control. The sample will be randomized as patients are admitted. First, they will be receiving the corresponding daily care. The first group of patients will receive the corresponding daily care. The patients in the intervention group will start the music therapy session through headphones, the patients in the control group will remain relaxed without any interruption during this time. All the variables will be collected before starting the study, during the study and at the end of the study.
Data analysis: A descriptive analysis of each variable will be performed. Subsequently, a bivariate analysis, previously checking the normality and homoscedasticity of the data.and homoscedasticity of the data. If statistically significant, post-hoc tests will be performed using Dunn's test.Dunn's test. Statistical significance will be accepted when p ≤ 0.05.
Study:
NCT06120660
Study Brief:
Protocol Section:
NCT06120660