Green Light for Post-Operative Wellness
ConditionSurgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRebecca E Kotcher, MD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >/= 18 years
Planned to undergo laparoscopic or robotic surgery at UPMC Shadyside Hospital
Anticipated post-operative length of stay >/= 48 hours
Able to speak and read English fluently, with the capacity to provide informed consent and complete the associated surveys independently
Disqualifiers
Pregnancy
History of significant ocular issues/dysfunction (†‡ ) (e.g., glaucoma, ocular trauma, macular degeneration, cataracts) that would interfere with the ocular mechanism of action
History of significant neurological disease (‡) (e.g., traumatic brain injury, stroke, neurodegenerative disease) that would compromise the reliability of pain screening and/or interfere with the central mechanism of action
History of bipolar disorder or schizophrenia, which could increase the risk of an adverse reaction to light exposure (i.e., acute mania)
Trial design
Design model
Parallel
Treatments tested in this trial
Bright Green Light Therapy
DeviceDay Light Classic Plus light therapy lamp with filter to yield bright green light.
Dim White Light Therapy
DeviceDay Light Classic Plus light therapy lamp with filter to yield dim white light.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Bright Green Light Exposure ArmExperimental treatment 1 intervention
Group B: Dim White Light Exposure ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incisional 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 2Secondary outcomes
1
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 22
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 23
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 74
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 7Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rebecca E Kotcher, MD
Lead sponsor
University of Pittsburgh
Sponsor institution
Source ClinicalTrials.gov