Pain, Postoperative Clinical Trial
Official title:
The Effects of a Music Therapist Designed Listening Program on Intraoperative Vitrectomy
NCT number | NCT03147235 |
Other study ID # | #170400 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | September 8, 2017 |
Verified date | April 2018 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
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 |
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