Topical Ice-therapy for Pain Modulation During Intravitreal Injections: A Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Overall Tolerability assessed by the visual analog scale
研究概览
简要总结
Purpose: To examine the difference in patient's pain experience in the setting of intravitreal anti-VEGF injections with pretreatment of topical ice-therapy compared with no-ice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients aged 18 or older evaluated by a single retina specialist at the University of Minnesota Department of Ophthalmology with a clinical indication necessitating an anti-VEGF intravitreal injection
排除标准
- 未提供
结局指标
主要结局
Overall Tolerability assessed by the visual analog scale
时间窗: This will be assessed at five minutes after the conclusion of the intravitreal injection
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to overall tolerability, while a rating of ten signifies the maximum self-reported subjective rating attributed to overall tolerability.
Itching assessed by the visual analog scale
时间窗: This will be assessed at five minutes after the conclusion of the intravitreal injection
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to itching, while a rating of ten signifies the maximum self-reported subjective rating attributed to itching.
Discomfort assessed by the visual analog scale
时间窗: This will be assessed at five minutes after the conclusion of the intravitreal injection
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to discomfort, while a rating of ten signifies the maximum self-reported subjective rating attributed to discomfort.
Burning assessed by the visual analog scale
时间窗: This will be assessed at five minutes after the conclusion of the intravitreal injection
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to burning, while a rating of ten signifies the maximum self-reported subjective rating attributed to burning.
Overall Pain assessed by the visual analog scale
时间窗: This will be assessed at five minutes after the conclusion of the intravitreal injection
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to overall pain, while a rating of ten signifies the maximum self-reported subjective rating attributed to overall pain.
次要结局
- Burning assessed by the visual analog scale(This will be assessed at 24-hours after the conclusion of the intravitreal injection)
- Discomfort assessed by the visual analog scale(This will be assessed at 24-hours after the conclusion of the intravitreal injection)
- Itching assessed by the visual analog scale(This will be assessed at 24-hours after the conclusion of the intravitreal injection)
- Overall Pain assessed by the visual analog scale(This will be assessed at 24-hours after the conclusion of the intravitreal injection)
- Overall Tolerability assessed by the visual analog scale(This will be assessed at 24-hours after the conclusion of the intravitreal injection)