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Generalized music therapy to reduce neuroactive drug needs in critically ill patients. Study protocol for a randomized trial.

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  • معلومة اضافية
    • المصدر:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
    • بيانات النشر:
      Original Publication: [London] : BioMed Central, 2006-
    • الموضوع:
    • نبذة مختصرة :
      Background: Critically ill patients are exposed to several physical and emotional stressors, needing analgesic and sedative drugs to tolerate invasive procedures and the harsh intensive care unit (ICU) environment. However, this pharmacological therapy presents several side effects: guidelines suggest using a light sedation target, keeping critically ill patients calm, conscious, and cooperative. Personalized music therapy (MT) can reduce stress and anxiety, decreasing the need for drugs. The aim of the current investigation is to compare different approaches for MT in the ICU: a personalized approach, with music selected by patients/families and listened through headphones, or a generalized approach, with ambient music chosen by a music therapist and transmitted through speakers.
      Primary Outcome: number of days "free from neuroactive drugs" in the first 28 days after ICU admission.
      Secondary Outcomes: total amount of neuroactive drugs (midazolam, propofol, morphine, fentanyl, haloperidol), stress during ICU stay (sleep at night, anxiety and agitation, use of physical restraints, stressors evaluated at discharge), the feasibility of generalized MT (interruptions requested by staff members and patients/families).
      Methods: Randomized, controlled trial with three groups of critically ill adults: a control group, without MT; a personalized MT group, with music for at least 2 h per day; a generalized MT group, with music for 12.5 h/day, subdivided into fifteen 50-min periods.
      Discussion: One hundred fifty-three patients are expected to be enrolled. This publication presents the rationale and the study methods, particularly the strategies used to build the generalized MT playlist. From a preliminary analysis, generalized MT seems feasible in the ICU and is positively received by staff members, critically ill patients, and families.
      Trial Registration: ClinicalTrials.gov Identifier: NCT03280329. September 12, 2017.
      (© 2024. The Author(s).)
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    • Contributed Indexing:
      Keywords: Conscious sedation; Critical illness; Intensive care units; Music therapy; Psychological stress
    • Molecular Sequence:
      ClinicalTrials.gov NCT03280329
    • الرقم المعرف:
      0 (Hypnotics and Sedatives)
      0 (Analgesics)
    • الموضوع:
      Date Created: 20240612 Date Completed: 20240613 Latest Revision: 20240615
    • الموضوع:
      20240615
    • الرقم المعرف:
      PMC11170779
    • الرقم المعرف:
      10.1186/s13063-024-08220-8
    • الرقم المعرف:
      38867317