Green Light for Post-Operative Wellness

NCT07218289 | Recruiting FDA Device

• 1 other identifier: STUDY25080068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

light therapy; post-operative pain; depression; anxiety; post-operative recovery

Outcome Measures

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.

  Post-Operative Day 2

Secondary Outcomes (7)

• Incisional Pain Intensity at Rest

  Post-Operative Day 2

• Oral Morphine Equivalents (OME)

  Post-Operative Day 1, and Post-Operative Day 2

• Sleep Disturbance

  Post-Operative Day 7

• Depression

  Post-Operative Day 7

• Anxiety

  Post-Operative Day 7

Study Arms (2)

Bright Green Light Exposure Arm

EXPERIMENTAL

Subjects randomized to this group will be exposed to bright green light via the Day Light Classic Plus light therapy lamp fitted with an appropriate color filter. The light will be administered for 4 hours daily for up to three days post-operatively while the subject is in the hospital.

Device: Bright Green Light Therapy

Dim White Light Exposure Arm

ACTIVE COMPARATOR

Subjects randomized to this group will be exposed to dim white light via the Day Light Classic Plus light therapy lamp fitted with an appropriate color filter. The light will be administered for 4 hours daily for up to three days post-operatively while the subject is in the hospital.

Device: Dim White Light Therapy

Interventions

Bright Green Light Therapy DEVICE

Day Light Classic Plus light therapy lamp with filter to yield bright green light.

Bright Green Light Exposure Arm

Dim White Light Therapy DEVICE

Day Light Classic Plus light therapy lamp with filter to yield dim white light.

Dim White Light Exposure Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rebecca E Kotcher, MD: lead

Study Sites (1)

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Rebecca Kotcher, MD

  University of Pittsburgh, UPMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Monroe, MPH, MBA

CONTACT

412-623-6382; monroeal@upmc.edu

Dayana Alsamsam, BSPS, MSc

CONTACT

alsamsamd@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 20, 2025
• Study Start: January 14, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)