An interventional study of vitrectomy with music listening in Pain, Postoperative and Music Therapy, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-01.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
This will be a prospective, randomized controlled trial with patients randomly assigned to either the experimental or control group. The experimental group will be exposed to the independent variable (IV) and the control group will not be exposed to the IV. The IV will be a music therapist- designed listening program during surgery. A total of 60 patients will be consecutively enrolled and undergo block randomization to either a music listening group or a control group (no music). Trained medical research personnel will assist with various parts of the study and will be defined as those individuals who have completed and are up-to-date on the Collaborative Institutional Training Initiative (CITI) training. These individuals will consist of a board certified music therapist, practicing ophthalmologists, and physicians-in-training.
This prospective trial will block randomize a consecutive cohort of patients undergoing routine vitrectomy surgery at an university hospital to a designed listening program during surgery or to nothing in order to determine whether music listening during surgery can measurably result in decreased patient pain assessed by the Wong-Baker Faces Pain scale. Secondary outcome measures will be blood pressure, need for anxiety medication, postoperative pain medication, and patient overall experience.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 57 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergoing vitrectomy surgery will listen to a designed playlist of music during the entire duration of surgery
Behavioral: vitrectomy with music listening
Patients undergoing vitrectomy surgery will not be exposed to music listening.
Those randomized to music listening will be exposed to a standardized playlist of previously validated relaxation music.
post-operative pain
post-operative pain as measured by the Wong-Baker Faces pain scale, 0 is no pain, 10 is the worst pain
Time frame: during post-operative recovery time, approximately 2 hours
patient satisfaction
patient satisfaction as measured by a modified version of the The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey
Time frame: during postoperative recovery time, approximately 2 hours
anti-anxiety medication
amount of anti-anxiety medication administered during surgery
Time frame: start to finish of surgery, approximately 1.5 hours
pain médication
amount of pain medication administered during surgery
Time frame: start to finish of surgery, approximately 1.5 hours
blood pressure
blood pressure during the surgical procedure
Time frame: start to finish of surgery, approximately 1.5 hours
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanderbilt University Medical Center