NCT00702039

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

April 1, 2008

Last Update Submit

January 12, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before and after the subject's intravitreal injection.

Study Arms (2)

1

Those patients receiving intravitreal injections who will be listening to classical music during injection.

Other: Music Therapy

2

Those patients receiving intravitreal injections who will not be listening to any music during injection.

Other: No Music

Interventions

No music will be played in patients in arm 2 of the study.

2

Classical music being played during intravitreal injection.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving intravitreal injections seen at the Yale Eye Center.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Eye Center

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ron Adelman, MD

    Yale University Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2008

First Posted

June 19, 2008

Study Start

February 1, 2007

Primary Completion

February 1, 2009

Study Completion

June 1, 2011

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations