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NCT Number: NCT07384585

Feasibility of Light Therapy in the Pediatric Intensive Care Unit (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.

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Key information

Conditions

Circadian Dysregulation Chronobiology Disorders Light Exposure Nervous System Diseases Pediatric Critical Illness

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location status: Recruiting

Location contact

Laura Beth Kalvas, PhD, RN

CONTACT

[email protected]

614-304-1872

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: bright light exposure

Primary outcomes

  1. Feasibility of light therapy for children, families, and staff.

    Time frame: Maximum of 5 days of light therapy.

    Feasibility of light therapy assessed via feedback surveys from children, families, and clinical staff.

  2. Duration of light therapy

    Time frame: Maximum of 5 days of light therapy.

    Hours of light therapy received per study day.

Secondary outcomes

  1. Adverse side effects of light therapy.

    Time frame: 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.

  2. Light levels

    Time frame: Maximum of 5 days of light therapy.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Beth Kalvas, PhD, RN

CONTACT

[email protected]

614-304-1872

Sponsors and collaborators

Lead sponsor

Laura Beth Kalvas

Other

Collaborators

  • Nationwide Children's Hospital

Registry information

Official study title

Feasibility of Light Therapy in the Pediatric ICU

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 3, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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