The goal of this single-arm observational study is to determine whether alpha music therapy, initiated early in the recovery period, can improve cognitive function for severe traumatic brain injury patients when compared to historic controls. Participants will listen to selected music through headphones. The investigators will compare cognitive function between groups at three time points: ICU discharge, hospital discharge, and three months after injury.
This single-arm observational study will include trauma patients with severe traumatic brain injury admitted to St. Elizabeth Youngstown Hospital Surgical Intensive Care Unit (ICU). Individual participation will last for 7 days (14 sessions) or until ICU discharge, whichever occurs first. The investigation is expected to last approximately 2 years (2026-2028) to accrue approximately 20 participants. Alpha-music therapy (AMT) will be played via headphones for 30 minutes twice each day for 7 study days (14 sessions) unless discharged from the ICU earlier. Patient monitoring will be performed before, during, and after AMT sessions.
Study Type
OBSERVATIONAL
Enrollment
35
St. Elizabeth Youngstown Hospital
Youngstown, Ohio, United States
St. Elizabeth Youngstown Hospital
Youngstown, Ohio, United States
Glasgow Coma Scale score
The total score ranges from 3 to 15, with 15 representing a fully alert, oriented person, and 3 indicating deep coma or death.
Time frame: Before and after alpha-music sessions on each of the 7 study days
Bispectral Index
Bispectral Index values range from 0 to 100. Lower numbers mean deeper sedation, while higher numbers indicate lighter sedation or wakefulness.
Time frame: Before and after alpha-music sessions on each of the 7 study days
Hospital survival or death
Patient status (alive or dead)
Time frame: Through study completion, an average of 1 year
Intensive care unit length of stay
Patient's length of stay in the intensive care unit
Time frame: Through study completion, an average of 1 year
Hospital length of stay
Patient's length of stay in the hospital
Time frame: Through study completion, an average of 1 year
Following commands
This is categorized as "yes" or "no" based on whether the patient can follow commands.
Time frame: At 3 months following hospital discharge
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