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

Not Applicable

Completed

• Conditions: Pain, Postoperative; Music Therapy
• Interventions: Behavioral: vitrectomy with music listening

• Registration Number: NCT03147235
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-10
• Primary Completion: 2017-09-08
• Study Completion: 2017-09-08
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Inclusion criteria will consist of patients already scheduled for elective vitrectomy surgery at a tertiary academic university hospital.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitrectomy with music listening	vitrectomy with music listening	Patients undergoing vitrectomy surgery will listen to a designed playlist of music during the entire duration of surgery

Primary Outcome Measures

Name	Time	Method
post-operative pain	during post-operative recovery time, approximately 2 hours	post-operative pain as measured by the Wong-Baker Faces pain scale, 0 is no pain, 10 is the worst pain

Secondary Outcome Measures

Name	Time	Method
pain médication	start to finish of surgery, approximately 1.5 hours	amount of pain medication administered during surgery
anti-anxiety medication	start to finish of surgery, approximately 1.5 hours	amount of anti-anxiety medication administered during surgery
patient satisfaction	during postoperative recovery time, approximately 2 hours	patient satisfaction as measured by a modified version of the The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey
blood pressure	start to finish of surgery, approximately 1.5 hours	blood pressure during the surgical procedure

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States