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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Via Headphones | Experimental | Headphones will be placed with patient-selected music playing for the duration of the surgical procedure. |
|
| Silence Via Headphones (Control) | Placebo Comparator | Headphones will be placed with silence for the duration of the surgical procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-Chosen Music | Other | Music played into headphones. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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") | At 24 hours (+- 3 hours) after surgery end time. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 24 hours (+- 3 hours) after surgery end time. |
| Measure | Description | Time Frame |
|---|---|---|
| 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") | Collected at 3 time points after surgery end time - 24 hours (+- 3 hours), 48 hours (+-3 hours) and 72 hours (+-3 hours) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ajita Prabhu, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Main Campus | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38890182 | Derived | Maskal SM, Gentle CK, Ellis RC, Tu C, Rosen MJ, Petro CC, Miller BT, Beffa LRA, Chang JH, Messer N, Melland-Smith M, Jeekel J, Prabhu AS. Does selective intraoperative music reduce pain following abdominal wall reconstruction? A double-blind randomized controlled trial. Hernia. 2024 Oct;28(5):1831-1841. doi: 10.1007/s10029-024-03092-y. Epub 2024 Jun 18. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D006555 | Hernia, Ventral |
| D046449 | Hernia, Abdominal |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Placebo |
| Other |
Silence into headphones. |
|
| 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") | 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. | 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. | During the first 72 hours after surgery end time. |
| Intraoperative sedative use | Total number of intravenous and inhaled anesthetics, benzodiazepines, and opioid medications. | From induction of anesthesia to arrival in the post anesthesia care unit on the day of procedure |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D001523 | Mental Disorders |