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| Name | Class |
|---|---|
| Nationwide Children's Hospital | OTHER |
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The goal of this clinical trial is to understand how easy or difficult it is for critically ill children (4-17 years old) to have light therapy while in the pediatric ICU. Participants will have a light meter at their bedside to measure light levels. Each morning, a light box will be placed at their bedside. Children, family, and staff will be asked to completed feedback surveys regarding the light therapy. Study participation will continue for a maximum of 5 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Light Therapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light Therapy | Other | Light therapy will be delivered via a light box for a maximum of 5 days in the pediatric ICU. Light therapy will be initiated 1 to 2 hours following participant's typical wake time, and continue for 3 hours. The light box light intensity is 10,000 lux with high blue light content (5,000 Kelvin). The light box blocks ultraviolet rays. The portable light box will be placed in front or to the side of the child at a distance of 2 feet. The light box can be moved with activity and turned off at any time if requested by the child, family, or staff. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of light therapy for children, families, and staff. | Feasibility of light therapy assessed via feedback surveys from children, families, and clinical staff. | Maximum of 5 days of light therapy. |
| Duration of light therapy | Hours of light therapy received per study day. | Maximum of 5 days of light therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse side effects of light therapy. | For each day of light therapy, presence of commonly reported side effects of light therapy (e.g., headache, eye strain, nausea, agitation) will be monitored and recorded in a daily monitoring form. Unanticipated problems and reportable adverse side effects will be monitored and recorded in an adverse event form. Presence of side effects will be determined from speaking with the bedside nurse, parent/caregiver, and child, review of the electronic medical record, and child/family/staff feedback surveys. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Beth Kalvas, PhD, RN | Contact | 614-304-1872 | laurabeth.kalvas@nationwidechildrens.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205 | United States |
Results of this small clinical trial testing feasibility of light therapy in the pediatric ICU will be shared in aggregate via publication at presentations at the study hospital and conferences.
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| ID | Term |
|---|---|
| D021081 | Chronobiology Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Maximum of 5 days of light therapy. |
| Light levels | Continuous bedside monitoring of light levels in lux via a light meter. | Maximum of 5 days of light therapy. |