Circadian Dysregulation, Light Exposure, Pediatric Critical Illness
Conditions
Brief summary
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.
Interventions
OTHERLight Therapy
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.
Sponsors
Laura Beth Kalvas
Nationwide Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Anticipated to remain admitted to the study hospital pediatric ICU for additional 48 hours * English-speaking parent/legally authorized representative available at the bedside
Exclusion criteria
* Patients unable to open their eyes to receive light therapy (Glasgow Coma Scale eye opening score of 1 or neuromuscular blockade) * Patients with contraindications to light therapy (e.g., migraines, retinal disease, diseases associated with retinal complications, blindness, bipolar disorder, seizure disorder, traumatic brain injury) * Suspected/identified neglect/abuse, Child Protective Services involvement, or ward of state * Children receiving palliative/end-of-life care * Unable to fit light box/cart in patient room
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of light therapy for children, families, and staff. | Maximum of 5 days of light therapy. | Feasibility of light therapy assessed via feedback surveys from children, families, and clinical staff. |
| Duration of light therapy | Maximum of 5 days of light therapy. | Hours of light therapy received per study day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse side effects of light therapy. | Maximum of 5 days 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. |
| Light levels | Maximum of 5 days of light therapy. | Continuous bedside monitoring of light levels in lux via a light meter. |
Countries
United States
Contacts
CONTACTLaura Beth Kalvas, PhD, RN
Outcome results
None listed