Musical Intervention on Stress Effects in Critically Ill Patients
Launched by UNIVERSITY OF OVIEDO · Nov 1, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring how listening to music may help reduce stress in critically ill patients who are on a ventilator. Researchers want to see if music can lower certain stress-related substances in the body, such as cortisol and interleukin-6, which can impact health. The goal is to find out if this musical intervention can help improve the overall well-being of patients in intensive care units (ICUs).
To participate in this study, patients must be adults who have been in the ICU for at least 24 hours and are currently receiving invasive mechanical ventilation, which means they need assistance to breathe. They should be sedated but not in pain during the procedure. However, patients with serious neurological or psychiatric issues, hearing problems, or who are expected to pass away soon are not eligible to join. If enrolled, participants can expect to listen to music as part of their care while their health is carefully monitored. This trial is currently looking for volunteers to help understand the potential benefits of music in critical care settings.
Gender
ALL
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.
About University Of Oviedo
The University of Oviedo is a renowned academic institution located in Spain, committed to advancing research and innovation in various fields, including healthcare and clinical studies. With a focus on fostering scientific excellence, the university collaborates with multidisciplinary teams to conduct cutting-edge clinical trials that aim to improve patient outcomes and contribute to medical knowledge. The institution is dedicated to adhering to the highest ethical standards and regulatory requirements, ensuring the integrity and reliability of its research efforts while promoting the translation of findings into clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oviedo, Asturias, Spain
Patients applied
Trial Officials
Alba Maestro-González, Ph.D.
Principal Investigator
University of Oviedo
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported