Effect of Music Therapy on Patients Undergoing Intravitreal Injections

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2008 by Yale University. Recruitment status was Recruiting

First Received on April 1, 2008. Last Updated on June 16, 2008 History of Changes

Sponsor:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00702039

Purpose

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.

Condition	Intervention
Intravitreal Injections Patient Satisfaction Patient Anxiety	Other: No Music Other: Music Therapy

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Effect of Music Therapy on Patients Undergoing Intravitreal Injections

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients receiving intravitreal injections seen at the Yale Eye Center.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702039

Contacts

Contact: Rajeev Seth, MD

203-785-2020

Locations

United States, Connecticut
Yale Eye Center	Recruiting
New Haven, Connecticut, United States, 06510
Contact: Rajeev Seth, MD 203-785-2020

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator:

Ron Adelman, MD

Yale University Department of Ophthalmology

More Information

No publications provided

Responsible Party:	Ron A. Adelman, MD, MPH, Associate Professor, Yale University School of Medicine
ClinicalTrials.gov Identifier:	NCT00702039 History of Changes
Other Study ID Numbers:	HIC# 0702002303
Study First Received:	April 1, 2008
Last Updated:	June 16, 2008
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012