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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147235
• Other study ID #: #170400
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: September 8, 2017

Study information

• Verified date: April 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 8, 2017
• Est. primary completion date: September 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Music Therapy
• Pain, Postoperative

Intervention

Behavioral:
• vitrectomy with music listening
Those randomized to music listening will be exposed to a standardized playlist of previously validated relaxation music.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	anti-anxiety medication	amount of anti-anxiety medication administered during surgery	start to finish of surgery, approximately 1.5 hours
Secondary	pain médication	amount of pain medication administered during surgery	start to finish of surgery, approximately 1.5 hours
Secondary	blood pressure	blood pressure during the surgical procedure	start to finish of surgery, approximately 1.5 hours