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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Music Therapy
• Intervention / Treatment: Behavioral: vitrectomy with music listening

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Stephen J Kim, MD, Vanderbilt Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): September 8, 2017
• Study Completion (Actual): September 8, 2017

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: #170400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No