Clinical trial NCT06120660: Musical Intervention on Stress Effects in Critically Ill Patients
Official title: Musical Intervention on Stress Effects in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Care
Respiration, Artificial
Sedation
Keywords: music therapy
anxiety
critical care
nursing
stress, psychological
respiration, artificial
Lead sponsor: University of Oviedo
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Enfermería Intensiva y Unidades Coronarias
First posted: 2023-11-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Adults
* Admitted to the ICU for a minimum of 24 hours
* Intubated patients undergoing invasive mechanical ventilation
* Arterial catheter carriers / central venous catheter
* Sedation level: BIS: 40 - 60
* No pain at the time of and during the procedure, which will be measured by a score of 0 on ESCID scale
* Not having previously undergone any other musical intervention.

Exclusion Criteria:

* Severe neurological disease or injury (CNS pathologies such as encephalitis, diffuse axonal injury, etc.)
* Severe psychiatric illness
* Suspected or confirmed drug or alcohol overdose/intoxication/abstinence
* Hearing impairment
* Skull lesions that preclude the use of headphones
* Patients with limitation of therapeutic effort or death expected within 24 hours
* Brain death diagnosis
* Failure to obtain informed consent from the legal representative within 72 hours of presentation
* Refusal of the responsible physician.

Primary outcomes:
measure: levels of serum cortisol
timeFrame: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.
measure: levels of prolactin
timeFrame: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.
measure: levels of interleukin 6
timeFrame: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.
Secondary outcomes:
measure: Bispectral Index (BIS)
timeFrame: Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.
measure: Blood Pressure
timeFrame: Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.
measure: Heart rate
timeFrame: Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.
measure: Respiratory rate
timeFrame: Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.
measure: Oxygen Saturation
timeFrame: Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
Study officials:
affiliation: University of Oviedo
name: Alba Maestro-González, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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