The Effect of Light Therapy on Post-Surgical Pain

NCT05853731 | Withdrawn FDA Device

• 1 other identifier: 22-011669
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Change in postoperative pain

  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

Study Arms (2)

Green light therapy group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Green light emitting diode DEVICE

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.

Also known as: GLED

Green light therapy group

White light emitting diode DEVICE

Filtered white light via light emitting diode (LED) displayed for up to 5 hours per day, as tolerated

Also known as: WLED

Placebo Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Sean Kiley, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: May 11, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)