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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Bright blue light will be administered using a Day-Light Classic Plus Light Therapy Lamp fitted with a LEE filter (#132, Medium Blue) and mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended). The light intervention will be administered at bedside for 4 hours daily during the morning/early afternoon hours, repeated for up to 3 days.
Bright full-spectrum (white) light will be administered using a Day-Light Classic Plus Light Therapy Lamp fitted with a LEE filter (#211 0.9 ND) and mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended). The light intervention will be administered at bedside for 4 hours daily during the morning/early afternoon hours, repeated for up to 3 days.
Across all arms, the usual ambient light in the inpatient room will not be modified. For the Bright Blue Light and Bright Full-Spectrum (White) Light arms, light will be added to the environment using a Day-Light Classic Plus Light Therapy Lamp as specified in the corresponding intervention descriptions. For the Usual Ambient Light arm, a Day-Light Classic Plus Light Therapy Lamp mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended) will be positioned at a 12-14 inches from eye level with the on/off switch in the off position. The lamp will be positioned in this manner for 4 hours daily during the morning/early afternoon hours, for up to 3 days.
Presbyterian Hospital, University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
RECRUITINGChest wall pain intensity, with incentive spirometer use
Chest wall pain intensity with deep breathing will be measured using the Numerical Rating Scale, elicited when the participant is taking a full tidal volume breath using their incentive spirometer. The Numerical Rating Scale is an 11-point scale ranging from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable. The scale will then be assessed at multiple timepoints during the 72 hour period of active study participation including twice daily on up to three intervention days (study days 1-3) and once on the morning following the final intervention day (study day 4 or day of discharge). Pain scale values over time will be compared across study arms.
Time frame: Up to 72 hours (assessed twice daily)
Intensive care unit-free days
Intensive care unit-free days at 30 days is calculated as 30 minus the number of days spent in an intensive care unit. Participants with death occurring within 30 days of enrollment will be assigned 0 ICU-free days. This will be assessed at 30 days using chart review and, for patients discharged from the hospital, confirmed during a single follow-up phone call. Thus, the range for each participant will be from 0 to 30 days. Differences in ICU-free days will be compared across study arms.
Time frame: 30 days
Rev-Erb alpha expression
Rev-Erb alpha is a circadian clock protein that will be used as a surrogate for circadian clock activation. Rev-Erb alpha expression will be quantified using Western Blot on blood samples collected each morning for up to 4 collections over the course of active study participation. Rev-erb alpha expression over time will be compared across study arms.
Time frame: Up to 72 hours (blood samples collected daily)
IL-6 concentration
Pro-inflammatory cytokine IL-6 concentration (pg/mL) will be quantified using ELISA testing on blood samples collected each morning for up to 4 collections over the course of active study participation. IL-6 concentration over time will be compared across study arms.
Time frame: Up to 72 hours (blood samples collected daily)
TNF-alpha concentration
Pro-inflammatory cytokine TNF-alpha concentration (pg/mL) will be quantified using ELISA testing on blood samples collected each morning for up to 4 collections over the course of active study participation. TNF-alpha concentration over time will be compared across study arms.
Time frame: Up to 72 hours (blood samples collected daily)
IL-10 concentration
Anti-inflammatory cytokine IL-10 concentration (pg/mL) will be quantified using ELISA testing on blood samples collected each morning for up to 4 collections over the course of active study participation. IL-10 concentration over time will be compared across study arms.
Time frame: Up to 72 hours (blood samples collected daily)
Opioid requirements
Daily opioid requirements as quantified by standardized oral morphine equivalents (OME) will be calculated daily during up to 72 hours of active study participation using opioid use data abstracted from the electronic medical record and a comprehensive OME conversion table. Opioid requirements over time will be compared across study arms.
Time frame: Up to 72 hours (calculated daily)
Chest wall pain intensity, at rest
Chest wall pain intensity at rest will be measured using the Numerical Rating Scale, elicited when the participant is at rest. The Numerical Rating Scale is an 11-point scale ranging from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable. The scale will assessed at baseline for the purpose of eligibility screening. The scale will then be assessed at multiple timepoints during the 72 hour period of active study participation, including twice daily during up to three intervention days and once on the morning following the final intervention day. Pain scale values over time will be compared across study arms.
Time frame: Up to 72 hours (assessed twice daily)
Hospital-free days
Hospital-free days at 30 days is calculated as 30 minus the number of days spent in an acute-care hospital, long-term acute care hospital (LTACH), or in an emergency department (ED). Participants with death occurring within 30 days of enrollment will be assigned 0 hospital-free days. This will be assessed at 30 days using chart review and, for patients discharged from the hospital, confirmed during a single follow-up phone call. Thus, the range for each participant will be from 0 to 30 days. Differences in hospital-free days will be compared across study arms.
Time frame: 30 days
Incidence of in-hospital delirium
The presence or absence of delirium will be assessed using the 3-minute diagnostic interview for Confusion Assessment Method-defined delirium (3D-CAM). Based on the bedside assessment, a published algorithm deems the participant either positive or negative for delirium. The assessment will then be administered at multiple timepoints during the 72 hour period of active study participation, including daily on each intervention day (study days 1-3) and on the morning following the final intervention day (study day 4 or day of discharge). The incidence of delirium within this timeframe will be compared across study arms.
Time frame: At 72 hours or date of discharge (assessed daily)
Incidence of pulmonary complications
Pulmonary complications are defined by a composite outcome (clinical pneumonia OR respiratory insufficiency requiring non-invasive positive pressure ventilation OR respiratory failure requiring mechanical ventilation). This dichotomous (yes/no) outcome will be assessed for each participant by electronic medical record review at 30 days post-enrollment. The incidence of pulmonary complications within this timeframe will be compared across study arms.
Time frame: 30 days
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