An interventional study of Patient-Chosen Music and Placebo in Postoperative Pain, Acute, Ventral Hernia and Hernia Abdominal Wall, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
The purpose of this study is to assess whether listening to music during surgery has an effect on pain or anxiety after surgery.
After being informed about the study and potential risks and meeting eligibility criteria, all patients giving written informed consent will be scheduled for their hernia repair surgery. On the day of surgery, patients will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to listen to patient-chosen music during their surgery via headphones or just listen to silence via headphones. Pain and anxiety will then be assessed after surgery.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 321 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Headphones will be placed with patient-selected music playing for the duration of the surgical procedure.
Other: Patient-Chosen Music
Headphones will be placed with silence for the duration of the surgical procedure.
Other: Placebo
Music played into headphones.
Silence into headphones.
Post operative Pain
Pain scores will be assessed using the Numeric Pain Rating Scale (NRS-11); The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time frame: At 24 hours (+- 3 hours) after surgery end time.
Post operative Anxiety
Anxiety scores will be assessed using State Trait Anxiety Index-6 (STAI-6) Anxiety tool (a 6 question patient-reported anxiety assessment). The higher the total, the greater the anxiety is.
Time frame: At 24 hours (+- 3 hours) after surgery end time.
Post operative Pain - 3 days
Pain scores will be assessed using the Numeric Pain Rating Scale (NRS-11); The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time frame: Collected at 3 time points after surgery end time - 24 hours (+- 3 hours), 48 hours (+-3 hours) and 72 hours (+-3 hours)
Post operative Pain - cumulative
Pain scores will be assessed using the Numeric Pain Rating Scale (NRS-11); The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time frame: Will be collected repeatedly by nursing staff per nursing protocol for the first 24 hours after surgery end time.
Post operative Anxiety - 3 days
Anxiety scores will be assessed using State Trait Anxiety Index-6 (STAI-6) Anxiety tool (a 6 question patient-reported anxiety assessment). The higher the total, the greater the anxiety is.
Time frame: Collected at 3 time points after surgery end time - 24 hours (+- 3 hours), 48 hours (+-3 hours) and 72 hours (+-3 hours)
Post operative opioid consumption
Cumulative opioid consumption converted into morphine milligram equivalents.
Time frame: During the first 72 hours after surgery end time.
Intraoperative sedative use
Total number of intravenous and inhaled anesthetics, benzodiazepines, and opioid medications.
Time frame: From induction of anesthesia to arrival in the post anesthesia care unit on the day of procedure
Ran from Jun 2022 to primary completion in Jul 2023, 13 months.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 13 months is above that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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