跳至主要内容
临床试验/NCT06971588
NCT06971588已完成不适用

The Role of Music in Enhancing Attention During Visual Field Exams for Pediatric Glaucoma Patients

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Number of False Positives On VFE

研究概览

简要总结

The goal of the study is to see if the use of music improves attention during visual field exams for pediatric glaucoma patients.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Glaucoma or glaucoma suspect

排除标准

  • •Post operative patient
  • •Non English speaking

研究组 & 干预措施

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.

干预措施: Music intervention (Other)

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.

干预措施: Music intervention (Other)

结局指标

主要结局

Number of False Positives On VFE

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验