Feasibility of Light Therapy in the Pediatric Intensive Care Unit (ICU)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorLaura Beth Kalvas
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Anticipated to remain admitted to the study hospital pediatric ICU for additional 48 hours
English-speaking parent/legally authorized representative available at the bedside
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Light Therapy
Other interventionLight 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Light TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of light therapy for children, families, and staff.
Feasibility of light therapy assessed via feedback surveys from children, families, and clinical staff.
Time frame
Maximum of 5 days of light therapy.2
Duration of light therapy
Hours of light therapy received per study day.
Time frame
Maximum of 5 days of light therapy.Secondary outcomes
1
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.
Time frame
Maximum of 5 days of light therapy.2
Light levels
Continuous bedside monitoring of light levels in lux via a light meter.
Time frame
Maximum of 5 days of light therapy.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Laura Beth Kalvas
Lead sponsor
Nationwide Children's Hospital
Sponsor institution
Nationwide Children's Hospital
Collaborator
Source ClinicalTrials.gov