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Completed

NCT Number: NCT03147235

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vitrectomy with music listening

Behavioral

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

Primary outcomes

  1. post-operative pain

    Time frame: during post-operative recovery time, approximately 2 hours

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

Secondary outcomes

  1. patient satisfaction

    Time frame: during postoperative recovery time, approximately 2 hours

    patient satisfaction as measured by a modified version of the The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey

  2. anti-anxiety medication

    Time frame: start to finish of surgery, approximately 1.5 hours

    amount of anti-anxiety medication administered during surgery

  3. pain médication

    Time frame: start to finish of surgery, approximately 1.5 hours

    amount of pain medication administered during surgery

  4. blood pressure

    Time frame: start to finish of surgery, approximately 1.5 hours

    blood pressure during the surgical procedure

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 10, 2017
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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