Status:
UNKNOWN
Musical Intervention on Stress Effects in Critically Ill Patients
Lead Sponsor:
University of Oviedo
Collaborating Sponsors:
Sociedad Española de Enfermería Intensiva y Unidades Coronarias
Conditions:
Critical Care
Respiration, Artificial
Eligibility:
All Genders
18+ years
Phase:
NA
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 mechani...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06120660
Start Date
October 14 2023
End Date
December 31 2025
Last Update
November 7 2023
Active Locations (1)
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1
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011