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Green Light for Post-Operative Wellness (GLOW)

R

Rebecca E Kotcher, MD

Status

Not yet enrolling

Conditions

Surgery

Treatments

Device: Bright Green Light Therapy
Device: Dim White Light Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07218289
STUDY25080068

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Bright Green Light Exposure Arm
Experimental group
Description:
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.
Treatment:
Device: Bright Green Light Therapy
Dim White Light Exposure Arm
Active Comparator group
Description:
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.
Treatment:
Device: Dim White Light Therapy

Trial contacts and locations

1

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Central trial contact

Sarah E Warner, BS; Amy Monroe, MPH, MBA

Data sourced from clinicaltrials.gov

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