search
Back to results

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

Primary Purpose

Pain, Postoperative, Music Therapy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vitrectomy with music listening
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

vitrectomy with music listening

vitrectomy without music listening

Arm Description

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

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

Outcomes

Primary Outcome Measures

post-operative pain
post-operative pain as measured by the Wong-Baker Faces pain scale, 0 is no pain, 10 is the worst pain

Secondary Outcome Measures

patient satisfaction
patient satisfaction as measured by a modified version of the The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey
anti-anxiety medication
amount of anti-anxiety medication administered during surgery
pain médication
amount of pain medication administered during surgery
blood pressure
blood pressure during the surgical procedure

Full Information

First Posted
May 8, 2017
Last Updated
April 30, 2018
Sponsor
Vanderbilt University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03147235
Brief Title
The Effects of a Music Therapist Designed Listening Program on Intraoperative Vitrectomy
Official Title
The Effects of a Music Therapist Designed Listening Program on Intraoperative Vitrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
September 8, 2017 (Actual)
Study Completion Date
September 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Music Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitrectomy with music listening
Arm Type
Experimental
Arm Description
Patients undergoing vitrectomy surgery will listen to a designed playlist of music during the entire duration of surgery
Arm Title
vitrectomy without music listening
Arm Type
No Intervention
Arm Description
Patients undergoing vitrectomy surgery will not be exposed to music listening.
Intervention Type
Behavioral
Intervention Name(s)
vitrectomy with music listening
Intervention Description
Those randomized to music listening will be exposed to a standardized playlist of previously validated relaxation music.
Primary Outcome Measure Information:
Title
post-operative pain
Description
post-operative pain as measured by the Wong-Baker Faces pain scale, 0 is no pain, 10 is the worst pain
Time Frame
during post-operative recovery time, approximately 2 hours
Secondary Outcome Measure Information:
Title
patient satisfaction
Description
patient satisfaction as measured by a modified version of the The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey
Time Frame
during postoperative recovery time, approximately 2 hours
Title
anti-anxiety medication
Description
amount of anti-anxiety medication administered during surgery
Time Frame
start to finish of surgery, approximately 1.5 hours
Title
pain médication
Description
amount of pain medication administered during surgery
Time Frame
start to finish of surgery, approximately 1.5 hours
Title
blood pressure
Description
blood pressure during the surgical procedure
Time Frame
start to finish of surgery, approximately 1.5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Kim, MD
Organizational Affiliation
Vanderbilt Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs