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Clinical Trials/NCT03147235
NCT03147235
Completed
N/A

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

Vanderbilt University Medical Center1 site in 1 country57 target enrollmentMay 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Vanderbilt University Medical Center
Enrollment
57
Locations
1
Primary Endpoint
post-operative pain
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2017
End Date
September 8, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephen J. Kim, MD

Associate Professor

Vanderbilt University Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

post-operative pain

Time Frame: 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 Outcomes

  • pain médication(start to finish of surgery, approximately 1.5 hours)
  • anti-anxiety medication(start to finish of surgery, approximately 1.5 hours)
  • patient satisfaction(during postoperative recovery time, approximately 2 hours)
  • blood pressure(start to finish of surgery, approximately 1.5 hours)

Study Sites (1)

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