Intravitreal InjectionsNCT00702039
Effect of Music Therapy on Patients Undergoing Intravitreal Injections
An observational study of Intravitreal Injections and Patient Satisfaction, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intravitreal Injections, Patient Satisfaction, Patient Anxiety
- What is being tested?
- No Music and Music Therapy
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving intravitreal injections seen at the Yale Eye Center.
Who may be able to join
- Those patients at least 18 years old already scheduled for intravitreal injections.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- No Music, Music Therapy
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No MusicOther
No music will be played in patients in arm 2 of the study.
Music TherapyOther
Classical music being played during intravitreal injection.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Those patients receiving intravitreal injections who will be listening to classical music during injection. Receives: Other: Music Therapy | |
| 2 | Those patients receiving intravitreal injections who will not be listening to any music during injection. Receives: Other: No Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after the subject's intravitreal injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startFeb 2007
- Primary completionFeb 2009
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravitreal InjectionsStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Adelman, MD, Principal investigator, Yale University Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702039
- Sponsor's protocol ID
- 0702002303
- Status last verified
- Jan 2018
- First submitted
- 1 Apr 2008
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music Therapy on Patients Undergoing Intravitreal Injections
- ClinicalTrials.gov ID
- NCT00702039
- Acronym / sponsor ID
- 0702002303
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Music TherapyThose patients receiving intravitreal injections who will be listening to classical music during injection. |
| 2 | – | Other: No MusicThose patients receiving intravitreal injections who will not be listening to any music during injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving intravitreal injections seen at the Yale Eye Center.
Key inclusion criteria (1 listed)
- Those patients at least 18 years old already scheduled for intravitreal injections.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No MusicNo music will be played in patients in arm 2 of the study. | Other | 2 |
| Music TherapyClassical music being played during intravitreal injection. | Other | 1 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Adelman, MD principal investigator
Yale University Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intravitreal Injections and Patient Satisfaction, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.