About this trial
The study plans to enroll a total of 132 patients. The goal of this study is to measure pre-and post-music intervention changes in patients' vital signs, serum- and plasma-level biomarkers by broad-spectrum proteomics analysis, metabolic analysis, and perceived pain, anxiety, and mood states as measured by validated questionnaires (STAI-S, POMS-SF, and VASP). We will collect demographic information on each participant. Participants will also complete the Brief Musical Experience Questionnaire (BMEQ) to investigate potential links between susceptibility to music-induced anxiolysis and prior musical training, preference and exposure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patient is unable or unwilling to provide informed consent.
Patient is deaf or hearing-disabled.
Patient is less than 18 years in age.
Patient was previously enrolled in the study.
Trial design
Single group
Treatments tested in this trial
Steinway Spirio M recording/player piano
Other interventionPatients will be equally randomized into one of the three arms (simulated live music, recorded music, or no music) applying the random permutated block. Randomization will be conducted via an approved institutional database with the randomization list generated by the study statistician.
Treatment groups
Trial outcomes
Primary outcomes
Stress and mood changes
Pre-post intervention changes in physiologic and perceived stress and mood changes by BP, STAI-S, VASP and POM-S.
Stress biomarkers
Proteomic and metabolomic analyses, in stress biomarkers and cytokines including IL-6, cortisol and epinephrine.
Secondary outcomes
BMEQ (Brief Music Experience Questionnaire)
Approximately 15 minutes to complete each time)
Sponsors and contacts
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