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

Feasibility of Light Therapy in the Pediatric ICU

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 Overview

• Status: Recruiting
• Conditions: Light Exposure; Circadian Dysregulation; Pediatric Critical Illness
• Intervention / Treatment: Other: Light Therapy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Beth Kalvas, PhD, RN; Phone Number: 614-304-1872; Email: laurabeth.kalvas@nationwidechildrens.org

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Recruiting
      • Nationwide Children's Hospital
      • Contact: Laura Beth Kalvas, PhD, RN; Phone Number: 614-304-1872; Email: laurabeth.kalvas@nationwidechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Light Therapy

Other: Light 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.; Other Names: bright light exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: Laura Beth Kalvas
• Collaborators: Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Chronobiology Disorders; Therapeutics; Phototherapy
• Other Study ID Numbers: STUDY00005565

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No