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Recruiting NCT07218289

Green Light for Post-Operative Wellness

No phase Interventional Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bright Green Light Therapy, Dim White Light Therapy.
Who it may be relevant to
Registry conditions: Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Green Light Therapy to Reduce Pain and Promote Wellness After Surgery: A Randomized Controlled Trial in Adult Post-Operative Patients

Overview

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

  • Device Bright Green Light Therapy
    Day Light Classic Plus light therapy lamp with filter to yield bright green light.
  • Device Dim White Light Therapy
    Day Light Classic Plus light therapy lamp with filter to yield dim white light.

Primary outcome measures

  • Incisional Pain Intensity with Movement [Time frame: Post-Operative Day 2]
Secondary outcome measures (7)
  • Incisional Pain Intensity at Rest [Time frame: Post-Operative Day 2]
  • Oral Morphine Equivalents (OME) [Time frame: Post-Operative Day 1, and Post-Operative Day 2]
  • Sleep Disturbance [Time frame: Post-Operative Day 7]
  • Depression [Time frame: Post-Operative Day 7]
  • Anxiety [Time frame: Post-Operative Day 7]
  • Overall quality of Post-Operative Recovery [Time frame: on Post-Operative Day 2, and Post-Operative Day 7]
  • Hospital Length of Stay [Time frame: Up to 30 Days Post-Operatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • UPMC Shadyside Hospital — Pittsburgh

Identifiers

NCT: NCT07218289 · STUDY25080068

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗