The Effects of a Music Therapist Designed Listening Program on Intraoperative Vitrectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of a Music Therapist Designed Listening Program on Intraoperative Vitrectomy

Conditions
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Pain, Postoperative, Music Therapy

Intervention / Treatment
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* Behavioral: vitrectomy with music listening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria will consist of patients already scheduled for elective vitrectomy surgery at a tertiary academic university hospital. Exclusion Criteria: Exclusion criteria consist of: patients with deafness or unilateral or bilateral severe hearing loss, unwillingness or inability to complete post-surgical surveys, previous vitrectomy surgeries, diagnosed anxiety disorder (claustrophobia, etc.), and/or chronic narcotic or substance abuse.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitrectomy with music listening<br>Patients undergoing vitrectomy surgery will listen to a designed playlist of music during the entire duration of surgery | Behavioral: vitrectomy with music listening<br>* Those randomized to music listening will be exposed to a standardized playlist of previously validated relaxation music.<br>|
| No Intervention: vitrectomy without music listening<br>Patients undergoing vitrectomy surgery will not be exposed to music listening. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |