RECRUITING

Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main goal of this clinical trial is to learn if light therapy improves pain and inflammation in adults with painful rib fractures. The main question it aims to answer is: \- Does bright blue light therapy in addition to standard pain treatments improve pain with breathing in adults with painful rib fractures? Researchers will compare participants who receive bright blue light therapy to participants who receive white light therapy and participants who receive only usual lighting conditions to look for differences in their pain control. In addition to their assigned light treatment, all participants will receive standard pain control treatments. Participants will be assigned randomly to one of three groups: one-third will be assigned to bright blue light therapy, one-third will be assigned to bright white light therapy, and one-third will be assigned to usual light only. They will receive their assigned light treatment for 4 hours during the morning/early afternoon for up to 3 days while they are in the hospital. On each day they receive the light treatment and on the day after their final light treatment: * They will be asked twice to rate their pain at rest and with taking a deep breath. * They will be tested to confirm that they are not experiencing delirium, or confusion related to being in the hospital. * They will be asked to wear a heart monitor to look for changes in their heart rate. * Blood samples will be collected to look for changes in inflammation and the circadian clock, the body's natural 24-hour cycle.

Official Title

Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma: A Randomized Controlled Trial in Adults With Rib Fractures

Quick Facts

Study Start:2024-10-23
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06626334

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age greater than or equal to 18 years
  2. * Admitted to a single large academic level I trauma center (Presbyterian/Montefiore hospital) within the first 48 hours of traumatic injury
  3. * Greater than or equal to 1 acute rib fracture
  4. * Pain related to rib fracture(s), by one or more of the following criteria: 1. Pain \>/= 4/10 at rest, 2. Pain \>/= 4/10 with incentive spirometer (IS) use, and/or 3. Inspiratory volume \< 1000 cc
  5. * Anticipated length of stay greater than or equal to 48 hours
  6. * Alert, with capacity to provide informed consent
  1. * Mechanical ventilation\* or non-invasive positive pressure ventilation administered for respiratory insufficiency prior to the time of informed consent
  2. * Delirium (positive CAM screening) at the time of informed consent
  3. * Ocular trauma, which may interfere with the mechanism of action
  4. * Traumatic brain injury (TBI) or history of TBI or stroke, which may interfere with the mechanism of action
  5. * Splenectomy upon admission or history of splenectomy, which may interfere with the mechanism of action
  6. * History of significant ocular dysfunction\*\* (i.e., macular degeneration, glaucoma, cataracts), which may interfere with the mechanism of action
  7. * History of cataract surgery, due to the possibility of blue light filtering intraocular lens placement
  8. * History of bipolar disorder or schizophrenia, which could increase the risk of an adverse reaction to light exposure (i.e., acute mania)
  9. * History of dementia, which would compromise the reliability of pain intensity and delirium measures
  10. * Or other condition in which a patient cannot open eyes to receive light intervention or report a pain score \*\*Myopia, hyperopia, and/or astigmatism corrected for with contact lenses or spectacle corrective eyeglasses will NOT be a criterion for exclusion

Contacts and Locations

Study Contact

Rebecca E Kotcher, MD
CONTACT
412-647-7243
kotcherre@upmc.edu

Principal Investigator

Rebecca E Kotcher, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

Presbyterian Hospital, University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Rebecca E Kotcher, MD

  • Rebecca E Kotcher, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-23
Study Completion Date2026-08

Study Record Updates

Study Start Date2024-10-23
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

  • Light Therapy
  • Blue Light Therapy
  • Pain Control
  • Analgesia
  • Immunomodulation
  • Bright Light Therapy

Additional Relevant MeSH Terms

  • Rib Fractures
  • Pain, Acute