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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitrectomy with music listening | Experimental | Patients undergoing vitrectomy surgery will listen to a designed playlist of music during the entire duration of surgery |
|
| vitrectomy without music listening | No Intervention | Patients undergoing vitrectomy surgery will not be exposed to music listening. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitrectomy with music listening | Behavioral | Those randomized to music listening will be exposed to a standardized playlist of previously validated relaxation music. |
|
| Measure | Description | Time Frame |
|---|---|---|
| post-operative pain | post-operative pain as measured by the Wong-Baker Faces pain scale, 0 is no pain, 10 is the worst pain | during post-operative recovery time, approximately 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| patient satisfaction | patient satisfaction as measured by a modified version of the The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey | during postoperative recovery time, approximately 2 hours |
| anti-anxiety medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen J Kim, MD | Vanderbilt Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37205 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D014821 | Vitrectomy |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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amount of anti-anxiety medication administered during surgery |
| start to finish of surgery, approximately 1.5 hours |
| pain médication | amount of pain medication administered during surgery | start to finish of surgery, approximately 1.5 hours |
| blood pressure | blood pressure during the surgical procedure | start to finish of surgery, approximately 1.5 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |