The Effect of Light Therapy on Post-Surgical Pain

November 17, 2023 updated by: Sean P. Kiley, Mayo Clinic

The Feasibility of Using Green Light Phototherapy for the Management of Acute Postoperative Pain

Researchers aim to demonstrate that the use of phototherapy is feasible and may reduce acute postoperative pain based on recent literature. The primary objective is to demonstrate that displaying light-emitting diodes [LED] can be achieved in the ICU setting in after cardiac surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary aim of this study to determine whether or not green light phototherapy is feasible after cardiac surgery.

Patients that will be undergoing heart surgery will be recruited to the study. After surgery they will be exposed to either green or white LEDs for up to 5 hours per day and up to one week after surgery.

After their exposure to light therapy, a survey will be given to the patient which will ask questions regarding tolerance of the therapy. A survey will also be given to the staff which will query whether or not the therapy was an impediment to workflow. In addition, the medical record will be reviewed to assess opiate usage in each group as an exploratory aim which may suggest differences in pain experiences.

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Status post heart surgery and are admitted in the ICU at Mayo Clinic, Florida.

Exclusion Criteria:

  • Patient with color blindness and/or untreated cataracts.
  • Patients who are hemodynamically unstable.
  • Patients with dementia/delirium.
  • Pregnancy.
  • Patient is unwilling to participate or provide informed consent.
  • High baseline narcotic baseline requirements that would skew the baseline impact on post-op opiate pain requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Green light therapy group
Subjects in the intensive care unit (ICU) setting after cardiac surgery will have green light therapy via green light emitting diode (GLED) for the duration of the ICU stay or up to 1 week.
Device: Green light emitting diode
Green light therapy via light emitting diode (LED) in the 520 nanometers (nm) range at 4 lux intensity for up to 5 hours per day, as tolerated.
Other Names:
  • GLED
Placebo Comparator: Placebo Group
Subjects in the intensive care unit (ICU) setting after cardiac surgery will have filtered white light emitting diodes (WLED) as a placebo for the duration of the ICU stay or up to 1 week.
Device: White light emitting diode
Filtered white light via light emitting diode (LED) displayed for up to 5 hours per day, as tolerated
Other Names:
  • WLED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in postoperative pain
Time Frame: Baseline, 1 week
Measured pain numeric rating scale from 0-10, where 0 was no pain and 10 was the worst pain imaginable. In this scale, a higher number indicates worse outcome and lower number indicates better outcome.
Baseline, 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Sean Kiley, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 29, 2023

First Submitted That Met QC Criteria

April 29, 2023

First Posted (Actual)

May 11, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 22-011669

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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