Ethics and Consent

At the time of informed consent, the investigators met with potential participants in a private treatment room or consult room out of the earshot of others to maintain privacy. To maintain confidentiality, we used several strategies including 1) storing patient identifiers, demographics, clinical characteristics, and patient-reported outcomes in REDCap, a secure, web-based application designed to support data capture for research studies;³¹ 2) identifying participants by the number assigned to them at the beginning of the study rather than by name; 3) storing electronic pain diary data on a secure password-protected server; 4) storing de-identified audio recordings of the participants’ interviews and music therapy interventions on a password-protected encrypted hard drive; and 5) storing paper research documents in a double-locked secure cabinet in the PI’s locked office.

This study was conducted in accordance with the Declaration of Helsinki. This study was approved by the University Hospitals Cleveland Medical Center Institutional Review Board. Written, informed consent was obtained from all participants. The study is registered in clinicaltrials.gov ({"type":"clinical-trial","attrs":{"text":"NCT03556657","term_id":"NCT03556657"}}NCT03556657).