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

NCT03147235 | Completed

• 1 other identifier: #170400
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Music Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• patient satisfaction

  during postoperative recovery time, approximately 2 hours

• anti-anxiety medication

  start to finish of surgery, approximately 1.5 hours

• pain médication

  start to finish of surgery, approximately 1.5 hours

• blood pressure

  start to finish of surgery, approximately 1.5 hours

Study Arms (2)

vitrectomy with music listening

EXPERIMENTAL

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

Behavioral: vitrectomy with music listening

vitrectomy without music listening

NO INTERVENTION

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

Interventions

vitrectomy with music listening BEHAVIORAL

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

vitrectomy with music listening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Stephen J Kim, MD

  Vanderbilt Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: May 1, 2017
• Primary Completion: September 8, 2017
• Study Completion: September 8, 2017
• Last Updated: May 1, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)