The Effect of Light Therapy on Post-Surgical Pain

Not Applicable

Withdrawn

• Conditions: Intensive Care Unit; Cardiac Surgery
• Interventions: Device: Green light emitting diode; Device: White light emitting diode

• Registration Number: NCT05853731
• Lead Sponsor: Mayo Clinic

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-04-29
• Study First Submitted QC: 2023-04-29
• Study First Posted: 2023-05-11
• Study Start: 2023-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Green light therapy group	Green light emitting diode	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.
Placebo Group	White light emitting diode	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.

Primary Outcome Measures

Name	Time	Method
Change in postoperative pain	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.

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States