Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04776616
Status:
UNKNOWN
Last Update Posted:
2021-03-02
First Post:
2021-02-25
Brief Title:
Green Light Therapy As a Non-Pharmacologic Intervention to Decrease Anxiety in Pregnant Women With Opioid Use Disorder
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Green Light Therapy As a Non-Pharmacologic Intervention to Decrease Anxiety in Pregnant Women With Opioid Use Disorder
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 We 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
We 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 We think this a is a low risk intervention in a pregnant population that has higher levels of anxiety when compared to the general population We believe based on animal studies that this could be effective and change the way we 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 recoverysustained 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
We 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 We think this a is a low risk intervention in a pregnant population that has higher levels of anxiety when compared to the general population We believe based on animal studies that this could be effective and change the way we 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 recoverysustained 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 We hope to enroll a maximum of 26 patients in this study with 11 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
We hope to enroll a maximum of 26 patients in this study with 11 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
We hope to enroll a maximum of 26 patients in this study with 11 randomization 13 control 13 experiment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None