Green Light Therapy As a Non-Pharmacologic Intervention to Decrease Anxiety in Pregnant Women With Opioid Use Disorder

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Device: Exposure to green LED light; Device: Exposure to white LED light

• Registration Number: NCT04776616
• Lead Sponsor: University of Arizona

Brief Summary

This is a clinical trial evaluating anxiety reduction for women with opioid use disorder affecting pregnancy. It is well documented that anxiety increases as pregnancy progresses. The investigators hypothesize that women who undergo green light therapy (experimental arm) will have a smaller increase in anxiety scores compared to the women who undergo white light therapy (control arm).

The investigators will also look at how much opiate replacement therapy increases women require during the study period, and how much opiate they require during admission for delivery. The investigators think this a is a low risk intervention in a pregnant population that has higher levels of anxiety when compared to the general population. The investigators believe based on animal studies that this could be effective, and change the way providers treat and support individuals with substance use disorder.

The opioid epidemic has negatively impacted our society at many levels. Finding non-pharmacologic ways to support patients while in recovery/sustained sobriety that are simple and low cost would be a step forward in providing compassionate and comprehensive treatment to individuals affected by Opioid Use Disorder.

Detailed Description

At time of enrollment, participants will be administered a States-Traits Anxiety Inventory (STAI) questionnaire, undergo screening for ACE score (adverse childhood experiences), and will be asked about basic demographic data. After they complete the initial surveys, the patient will be assigned to either the control group or the experimental group. They will be sent home with the light, along with instructions to use their light every night for 1-2 hours as ambient lighting. The investigators hope to enroll a maximum of 26 patients in this study with 1:1 randomization (13 control, 13 experiment).

At approximately halfway through the intervention, the PI will call the patient and ask how often she has been using the light, how long she uses the light for every night, and whether she has noticed any effects (either positive or negative).

At the prenatal visit around 36 weeks gestation or at time of delivery, whichever is sooner, patients will be asked by the PI to turn in their light and also fill out the STAI once again.

After delivery, the PI will review the medical record and record any change in opioid replacement therapy during pregnancy as well as the total dose of opiate required during the inpatient admission for delivery.

The investigators hope to enroll a maximum of 26 patients in this study with 1:1 randomization (13 control, 13 experiment)

Study Timeline

• Status Verified: 2021-02
• Study Start: 2021-02-24
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-02
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

Pregnant women between 20 - 32 weeks gestation with a diagnosis of opiate use disorder receiving care through Banner University Medical Center North Mothers Over Medicine (MOMs) Clinic, a high-risk pregnancy clinic for women with substance use disorder complicating pregnancy

Exclusion Criteria

1. Inability to speak or understand English
2. Incarcerated individuals
3. Age <18 yo

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exposure to green LED light	Exposure to green LED light	Participants will be exposed to green LED strip lights in a dark room for 2 hours a day.
Exposure to white LED light	Exposure to white LED light	Participants will be exposed to white LED strip lights in a dark room for 2 hours a day

Primary Outcome Measures

Name	Time	Method
Change in anxiety over course of intervention, measured by STAI	4-16 weeks	The participants will be given a States-Traits Anxiety Inventory (STAI) questionnaire at time of enrollment and then again at time of completion. Score range is 20 to 80, with higher scores indicating greater anxiety.

Secondary Outcome Measures

Name	Time	Method
Change in Opiate Replacement Therapy	4-20 weeks	The participants dose of opiate replacement therapy will be recorded at time of enrollment, at time of completion of the study, and also at time of delivery if it doesn't coincide with completion of study.
Opiate used during admission for delivery	1-7 days	The participants total dose of opiate administered during the admission for delivery will be recorded.

Trial Locations

Locations (1)

Banner North Clinic, Obstetrics & Gynecology Clinic; 🇺🇸 Tucson, Arizona, United States