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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ice-therapy | Active Comparator | Ice therapy will be provided prior to the provision of the intravitreal injection |
|
| No Ice-therapy | Placebo Comparator | No ice therapy will be provided prior to the provision of the intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ice-therapy | Other | Ice therapy will be provided prior to intravitreal injection provision |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort assessed by the visual analog scale | 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. | This will be assessed at five minutes after the conclusion of the intravitreal injection |
| Itching assessed by the visual analog scale | 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. | This will be assessed at five minutes after the conclusion of the intravitreal injection |
| Burning assessed by the visual analog scale | 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. | This will be assessed at five minutes after the conclusion of the intravitreal injection |
| Overall Pain assessed by the visual analog scale | 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. | This will be assessed at five minutes after the conclusion of the intravitreal injection |
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort assessed by the visual analog scale | 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. | This will be assessed at 24-hours after the conclusion of the intravitreal injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jade Moon, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007053 | Ice |
| ID | Term |
|---|---|
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 |
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| No Ice-therapy |
| Other |
No additional intervention (i.e.) ice therapy will be provided prior to intravitreal injection provision |
|
| Overall Tolerability assessed by the visual analog scale | 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. | This will be assessed at five minutes after the conclusion of the intravitreal injection |
| Itching assessed by the visual analog scale | 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. | This will be assessed at 24-hours after the conclusion of the intravitreal injection |
| Burning assessed by the visual analog scale | 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. | This will be assessed at 24-hours after the conclusion of the intravitreal injection |
| Overall Pain assessed by the visual analog scale | 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. | This will be assessed at 24-hours after the conclusion of the intravitreal injection |
| Overall Tolerability assessed by the visual analog scale | 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. | This will be assessed at 24-hours after the conclusion of the intravitreal injection |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D014887 | Weather |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |