This is an unblinded, parallel group randomized controlled trial to evaluate bright green light as an adjunct therapy after surgery at UPMC Shadyside. The primary outcome measure will be pain intensity with secondary outcome measures including opioid requirements, sleep quality, mood, and overall post-operative recovery. Specific aims/hypotheses for this study are as follows: Aim 1: To assess bright green light therapy's potential as a complementary post-operative analgesic strategy in patients recovering from surgery Hypothesis 1: Participants exposed to bright green light, in comparison to dim white (ambient) light, will have improved postoperative pain scores and lower opioid use. Aim 2: To examine the impact of bright green light therapy on patient-centered measures of post-operative recovery that may be related to improved circadian function. Hypothesis 2: Participants exposed to bright green light, in comparison to dim white (ambient) light, will have improved quality of post-operative recovery, enhanced sleep, and reduced anxiety and depression.
This research study is being done to evaluate the use of light therapy following surgery at UPMC Shadyside Hospital (Pittsburgh, PA). Light therapy after surgery may reduce pain and pain medication requirements, and it may improve sleep, mood, and overall post-surgery recovery. The proposed study design of a randomized controlled trial investigates the use of bright green light therapy for post-operative pain management and wellness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Day Light Classic Plus light therapy lamp with filter to yield bright green light.
Day Light Classic Plus light therapy lamp with filter to yield dim white light.
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States
RECRUITINGIncisional Pain Intensity with Movement
Incisional pain with movement (after coughing) will be reported using a Numerical Rating Scale (NRS), scored from 0 to10, with 0 indicates "no pain" and 10 indicates "the worst pain imaginable". Post-intervention NRS on Post-Operative Day 2 will be compared between study arms as the primary outcome.
Time frame: Post-Operative Day 2
Incisional Pain Intensity at Rest
Incisional pain at rest will be reported using a Numerical Rating Scale (NRS), scored from 0 to10, where 0 indicates "no pain" and 10 indicates "the worst pain imaginable". Post-intervention NRS on Post-Operative Day 2 will be compared between study arms as a secondary outcome.
Time frame: Post-Operative Day 2
Oral Morphine Equivalents (OME)
Total Opioid use will be obtained from the electronic medical record. Oral Morphine Equivalent (OME) use during the first 48-hours after surgery will be compared (on Post-Operative Days 1 and 2) between study arms.
Time frame: Post-Operative Day 1, and Post-Operative Day 2
Sleep Disturbance
Sleep disturbance will be assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance 8-Item Short Form. Standardized T-scores (population mean = 50, standard deviation =10) will be compared between study arms as a secondary outcome. Higher scores will indicate higher levels of sleep disturbance.
Time frame: Post-Operative Day 7
Depression
Depression will be measured using the PROMIS (Patient-Reported Outcomes Measurement Information System) Depression 8-Item Short Form. Minimum score of 8, and Maximum score of 40. Higher scores will indicate higher levels of depression (worse outcome). Standardized T-scores (population mean = 50, standard deviation = 10) on post-operative Day 7 will be compared between study arms as a secondary outcome.
Time frame: Post-Operative Day 7
Anxiety
Anxiety will be assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety 8-Item Short Form. Scores range from 8 to 40. Higher scores will indicate greater anxiety.
Time frame: Post-Operative Day 7
Overall quality of Post-Operative Recovery
Overall recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, scored from 0 to 150. Higher scores will indicate better recovery. QOR-15 will be compared between study arms as a secondary outcome on both of Post-Operative Day 2 and Post-Operative Day 7.
Time frame: on Post-Operative Day 2, and Post-Operative Day 7
Hospital Length of Stay
Hospital length of stay will be reported as the total of full days spent in an acute care hospital or emergency department within 30 days after surgery (0-30) and will be compared between study arms as a secondary outcome.
Time frame: Up to 30 Days Post-Operatively
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