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

NCT ID: NCT03147235

Last Updated: 2018-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2017-09-08

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.

Conditions

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Pain, Postoperative Music Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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vitrectomy with music listening

Patients undergoing vitrectomy surgery will listen to a designed playlist of music during the entire duration of surgery

Group Type EXPERIMENTAL

vitrectomy with music listening

Intervention Type BEHAVIORAL

Those randomized to music listening will be exposed to a standardized playlist of previously validated relaxation music.

vitrectomy without music listening

Patients undergoing vitrectomy surgery will not be exposed to music listening.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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vitrectomy with music listening

Those randomized to music listening will be exposed to a standardized playlist of previously validated relaxation music.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Stephen J. Kim, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen J Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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#170400

Identifier Type: -

Identifier Source: org_study_id

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