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The Effect of Light Therapy on Post-Surgical Pain

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05853731
Collaborator
(none)
124
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Green light emitting diode
  • Device: White light emitting diode
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Feasibility of Using Green Light Phototherapy for the Management of Acute Postoperative Pain
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in postoperative pain [Baseline, 1 week]

      Measured using numeric pain scores

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Florida Jacksonville Florida United States 32224

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Sean Kiley, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sean P. Kiley, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05853731
    Other Study ID Numbers:
    • 22-011669
    First Posted:
    May 11, 2023
    Last Update Posted:
    May 11, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of May 11, 2023