Feasibility of Light Therapy in the Pediatric Intensive Care Unit (ICU)

N/ANot Yet RecruitingNCT07384585

Laura Beth Kalvas30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Circadian Dysregulation Light Exposure Pediatric Critical Illness

Interventions

Light TherapyOTHER

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.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Within 48 hours of pediatric ICU admission at study hospital * 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) * Patients with contraindications to light therapy (e.g., migraines, retinal disease, diseases associated with retinal complications, blindness, bipolar disorder, traumatic brain injury) * Suspected/identified neglect/abuse, Child Protective Services involvement, or ward of state * Children receiving palliative/end-of-life care

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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.

Duration of light therapy

Hours of light therapy received per study day.

Time frame: Maximum of 5 days of light therapy.

Secondary Outcomes

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.

Light levels

Continuous bedside monitoring of light levels in lux via a light meter.

Time frame: Maximum of 5 days of light therapy.

Central Contacts

Laura Beth Kalvas, PhD, RN

CONTACT

614-304-1872 laurabeth.kalvas@nationwidechildrens.org

Data from ClinicalTrials.gov

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