Effect of Music Therapy on Patients Undergoing Intravitreal Injections

January 12, 2018 updated by: Yale University

Multiple studies in various specialties, including ophthalmology, are reported in the literature that show that playing music during a procedure (dubbed music therapy) increases patient satisfaction and may reduce patient anxiety and stress levels.

There is no study in the literature that assesses the effects of listening to music in patients undergoing intravitreal injections. This study aims to assess whether listening to music improves patient satisfaction or reduces their anxiety levels in subjects undergoing intravitreal injections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving intravitreal injections seen at the Yale Eye Center.

Description

Inclusion Criteria:

  • Those patients at least 18 years old already scheduled for intravitreal injections.

Exclusion Criteria:

  • Those patients not interested in participating in the study or not capable of filling out the questionnaire secondary to limited mental capability.
  • Non- English speaking subjects will be excluded from the study.
  • Those patients that participated in the study will not be allowed to participate a second time.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Those patients receiving intravitreal injections who will be listening to classical music during injection.
Other: Music Therapy
Classical music being played during intravitreal injection.
2
Those patients receiving intravitreal injections who will not be listening to any music during injection.
Other: No Music
No music will be played in patients in arm 2 of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
This study aims to assess what affects music therapy has on patients receiving intravitreal injections. The subject will take a Satisfaction Survey after the procedure and an Anxiety Survey before and after the injection.
Time Frame: Before and after the subject's intravitreal injection.
Before and after the subject's intravitreal injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Ron Adelman, MD, Yale University Department of Ophthalmology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 0702002303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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