The Effect of Light Therapy on Post-Surgical Pain

NCT ID: NCT05853731

Last Updated: 2024-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intensive Care Unit Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Green light emitting diode

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

White light emitting diode

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

White light emitting diode

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

Intervention Type DEVICE

Other Intervention Names

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GLED WLED

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Sean P. Kiley

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sean Kiley, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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22-011669

Identifier Type: -

Identifier Source: org_study_id

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