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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03147235
Enrollment
57
Registered
2017-05-10
Start date
2017-05-01
Completion date
2017-09-08
Last updated
2018-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Music Therapy, Pain, Postoperative

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.

Interventions

BEHAVIORALvitrectomy with music listening

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

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Inclusion criteria will consist of patients already scheduled for elective vitrectomy surgery at a tertiary academic university hospital.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
post-operative painduring post-operative recovery time, approximately 2 hourspost-operative pain as measured by the Wong-Baker Faces pain scale, 0 is no pain, 10 is the worst pain

Secondary

MeasureTime frameDescription
patient satisfactionduring postoperative recovery time, approximately 2 hourspatient satisfaction as measured by a modified version of the The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey
anti-anxiety medicationstart to finish of surgery, approximately 1.5 hoursamount of anti-anxiety medication administered during surgery
pain médicationstart to finish of surgery, approximately 1.5 hoursamount of pain medication administered during surgery
blood pressurestart to finish of surgery, approximately 1.5 hoursblood pressure during the surgical procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026