GlaucomaNCT06971588
The Role of Music in Enhancing Attention During Visual Field Exams for Pediatric Glaucoma Patients
A study testing Music intervention in people with Glaucoma, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of the study is to see if the use of music improves attention during visual field exams for pediatric glaucoma patients. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Music intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 1 May 2026
- Phase
- Interventional
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Glaucoma or glaucoma suspect
Who cannot join
- Post operative patient
- Non English speaking
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the study is to see if the use of music improves attention during visual field exams for pediatric glaucoma patients.
Read the detailed description
This study aims to determine if music can be used as an intervention to improve attention and quality of results in pediatric glaucoma patients taking visual field exams. The investigators also want to determine the most effective method and type of music by which it can be implemented into the test to improve patient experience and results. If there is an improvement, it will benefit the patient and the provider in administering the test and the utility of the results.
To that end, patients between the ages of 8-17 with Glaucoma or glaucoma suspect diagnosis will be recruited from the clinic with consent from their parents and assent from the patient to participate in the study. They will come in on two scheduled dates after being randomized to either a control or experimental group. On the first date, the participants assigned to the control group will complete the Visual Field Exams (VFE) without music, and the experimental group will listen to music and complete a pre and posttest survey regarding test taking experience. On the second date, the groups will switch and the participant will complete the other part of the study. Results will then be analyzed and compared between the groups and previous results.
- Conditions
- Glaucoma
- Being tested
- Music intervention
- Keywords
- Pediatric, Glaucoma, Music, Research, Ophthalmology
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
The intervention will involve patient-chosen music.
| Study group | Role | What they receive |
|---|---|---|
| Music Group (first) | Experimental | This arm will involve the use of music during their initial VFE, and then they will take part in the non-music group during their second visit. Receives: Other: Music intervention |
| Non-Music Group (first) | Experimental | This arm will involve the completion of the VFE with no music first, and then they will crossover and complete the arm involving the use of music during the visual field exam. Receives: Other: Music intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of False Positives On VFE
This outcome measurement will be used to assess reliability by seeing how often the patients were responding to stimuli that weren't present during the VFE. Assessment will be done by the physician after completion of the VFE by patient which takes about 10 minutes.
Measured: Baseline, Follow-up visit up to 4 weeks
Number of False Negatives On VFE
This measurement is a reliability tool to see if the patient missed any stimuli during VFE. Assessment will be done by the physician after completion of the VFE by patient which takes about 10 minutes.
Measured: Baseline, Follow-up visit up to 4 weeks
Number of Fixation Losses on VFE
This will evaluate any gaze deviation by the patient during VFE as a marker of inattention and test reliability. Assessment will be done by the physician after completion of the VFE by patient which takes about 10 minutes.
Measured: Baseline, Follow-up visit up to 4 weeks
Test Duration (minutes) On VFE
This will evaluate the length of the test as a marker for inattention and reliability if patient takes longer to complete the exam in one group or the other. Assessment will be done by the physician after completion of the VFE by patient which takes about 10 minutes.
Measured: Baseline, Follow-up visit up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Jun 2025
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will involve the child being randomized to a control and experimental group, and about 2 weeks after the initial test, they will be asked to come in and take part in the alternate study group. During the control visit, the child will take the visual field exam as they would in their routine care.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Courtney Kraus, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971588
- Sponsor's protocol ID
- IRB00484910
- Status last verified
- May 2026
- First submitted
- 6 May 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muralidharan S, Ichhpujani P, Bhartiya S, Singh RB. Eye-tunes: role of music in ophthalmology and vision sciences. Ther Adv Ophthalmol. 2021 Sep 2;13:25158414211040890. doi: 10.1177/25158414211040890. eCollection 2021 Jan-Dec.
PubMed 34497975Blood AJ, Zatorre RJ. Intensely pleasurable responses to music correlate with activity in brain regions implicated in reward and emotion. Proc Natl Acad Sci U S A. 2001 Sep 25;98(20):11818-23. doi: 10.1073/pnas.191355898.
PubMed 11573015
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Music in Enhancing Attention During Visual Field Exams for Pediatric Glaucoma Patients
- ClinicalTrials.gov ID
- NCT06971588
- Acronym / sponsor ID
- IRB00484910
- Conditions
- Glaucoma
- Keywords
- Pediatric, Glaucoma, Music, Research, Ophthalmology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 14 May 2025 (actual)
- 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.
The goal of the study is to see if the use of music improves attention during visual field exams for pediatric glaucoma patients.
Detailed description
This study aims to determine if music can be used as an intervention to improve attention and quality of results in pediatric glaucoma patients taking visual field exams. The investigators also want to determine the most effective method and type of music by which it can be implemented into the test to improve patient experience and results. If there is an improvement, it will benefit the patient and the provider in administering the test and the utility of the results.
To that end, patients between the ages of 8-17 with Glaucoma or glaucoma suspect diagnosis will be recruited from the clinic with consent from their parents and assent from the patient to participate in the study. They will come in on two scheduled dates after being randomized to either a control or experimental group. On the first date, the participants assigned to the control group will complete the Visual Field Exams (VFE) without music, and the experimental group will listen to music and complete a pre and posttest survey regarding test taking experience. On the second date, the groups will switch and the participant will complete the other part of the study. Results will then be analyzed and compared between the groups and previous results.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will involve the child being randomized to a control and experimental group, and about 2 weeks after the initial test, they will be asked to come in and take part in the alternate study group. During the control visit, the child will take the visual field exam as they would in their routine care.
| Arm | Type | Receives |
|---|---|---|
| Music Group (first) | Experimental | Other: Music interventionThis arm will involve the use of music during their initial VFE, and then they will take part in the non-music group during their second visit. |
| Non-Music Group (first) | Experimental | Other: Music interventionThis arm will involve the completion of the VFE with no music first, and then they will crossover and complete the arm involving the use of music during the visual field exam. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Glaucoma or glaucoma suspect
Key exclusion criteria (2 listed)
- Post operative patient
- Non English speaking
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 |
|---|---|---|
| Music interventionThe intervention will involve patient-chosen music. | Other | Music Group (first), Non-Music Group (first) |
Primary outcome
Number of False Positives On VFE
Time frame: Baseline, Follow-up visit up to 4 weeks
This outcome measurement will be used to assess reliability by seeing how often the patients were responding to stimuli that weren't present during the VFE. Assessment will be done by the physician after completion of the VFE by patient which takes about 10 minutes.
Number of False Negatives On VFE
Time frame: Baseline, Follow-up visit up to 4 weeks
This measurement is a reliability tool to see if the patient missed any stimuli during VFE. Assessment will be done by the physician after completion of the VFE by patient which takes about 10 minutes.
Number of Fixation Losses on VFE
Time frame: Baseline, Follow-up visit up to 4 weeks
This will evaluate any gaze deviation by the patient during VFE as a marker of inattention and test reliability. Assessment will be done by the physician after completion of the VFE by patient which takes about 10 minutes.
Test Duration (minutes) On VFE
Time frame: Baseline, Follow-up visit up to 4 weeks
This will evaluate the length of the test as a marker for inattention and reliability if patient takes longer to complete the exam in one group or the other. Assessment will be done by the physician after completion of the VFE by patient which takes about 10 minutes.
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 5 May 2026.
- Background: PubMed 34497975Muralidharan S, Ichhpujani P, Bhartiya S, Singh RB. Eye-tunes: role of music in ophthalmology and vision sciences. Ther Adv Ophthalmol. 2021 Sep 2;13:25158414211040890. doi: 10.1177/25158414211040890. eCollection 2021 Jan-Dec.
- Background: PubMed 11573015Blood AJ, Zatorre RJ. Intensely pleasurable responses to music correlate with activity in brain regions implicated in reward and emotion. Proc Natl Acad Sci U S A. 2001 Sep 25;98(20):11818-23. doi: 10.1073/pnas.191355898.
- Baldwin, M., \& Lewis, R. (2017). Positive valence music restores executive control over sustained attention. PLOS ONE, 12(11), e0186231. https://doi.org/10.1371/journal.pone.0186231Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Courtney Kraus, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Glaucoma, run by Johns Hopkins 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 2 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 5 May 2026. 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?
Number of False Positives On VFE (time frame: Baseline, Follow-up visit up to 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06971588, which also lists 2 linked publications.
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 5 May 2026.