Surgery
Conditions
Keywords
light therapy, post-operative pain, depression, anxiety, post-operative recovery
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBright Green Light Therapy
Day Light Classic Plus light therapy lamp with filter to yield bright green light.
DEVICEDim White Light Therapy
Day Light Classic Plus light therapy lamp with filter to yield dim white light.
Sponsors
Rebecca E Kotcher, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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) * History of splenectomy, which would interfere with the mechanism of action * Ocular issues corrected with contact lenses or spectacle corrective eyeglasses will NOT be considered a criterion for exclusion ‡Unclear cases will be at the discretion of the PI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incisional Pain Intensity with Movement | Post-Operative Day 2 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incisional Pain Intensity at Rest | Post-Operative Day 2 | 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. |
| Oral Morphine Equivalents (OME) | Post-Operative Day 1, and Post-Operative Day 2 | 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. |
| Sleep Disturbance | Post-Operative Day 7 | 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. |
| Depression | Post-Operative Day 7 | 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. |
| Anxiety | Post-Operative Day 7 | 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. |
| Overall quality of Post-Operative Recovery | on Post-Operative Day 2, and Post-Operative Day 7 | 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. |
| Hospital Length of Stay | Up to 30 Days Post-Operatively | 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. |
Countries
United States
Contacts
CONTACTAmy Monroe, MPH, MBA
CONTACTDayana Alsamsam, BSPS, MSc
PRINCIPAL_INVESTIGATORRebecca Kotcher, MD
University of Pittsburgh, UPMC
Outcome results
None listed