|
RESET StudyWriting to REduce Stress in ExpectanT Moms
|
What is the RESET Study?
The RESET Study is also known as the Writing to Reduce Stress in Expectant Moms Study. This study is a journaling-based intervention study that collects detailed data and biologic samples. It will help researchers to understand whether expressive writing can alleviate prenatal stress and improve birth outcomes in high risk pregnancies.
Why am I being asked to participate?
You are being asked to be in the study because you may be at a high risk for adverse pregnancy outcomes and meet eligibility criteria through the Perceived Stress Scale.
What will I have to do?
We will discuss the study with you in detail. If you agree to participate, you will review an online consent form and HIPAA form in detail.
Once you agree to participate and sign the consent form and the HIPAA form, you will fill out a series of surveys about medical history, pregnancy history, and psychosocial distress experiences. We will also collect samples of your blood and urine as well as vaginal swabs. This process will be repeated again during a regularly scheduled prenatal appointment between 24- and 28-weeks of gestation.
If you are assigned to the writing intervention group, you will be asked to respond to a prompt for 15-minutes in the provided journal/online once a week for 8 weeks.
We will obtain samples from the placenta/ umbilical cord, and cord blood after delivery (this tissue is normally discarded). 4 to 6 weeks after you deliver, we will ask you to complete a final round of surveys.
Your study timeline:
We will collect all of your blood when you are having routine clinical blood work as ordered by your doctor.
There are no study-only visits to the hospital or clinic.
Are there any risks?
Study-related risks are low. There is a small chance of bruising, bleeding, or discomfort when we draw your blood, but there are no extra blood draws only for the study. Collecting the placenta and umbilical cord and cord blood occurs after delivery. The placenta is normally discarded after delivery. Every effort is made to protect your confidentiality.
If you experience emotional distress during this study and desire help, you may be referred to UNC psychological support services.
Will it cost me anything to be in the study?
There are no costs to participate.
Will I be paid to participate?
You will receive a $20 gift card or an equivalent value in parking passes for your time. Additionally, you will receive a tote bag, pen, and journal.
The RESET Study is also known as the Writing to Reduce Stress in Expectant Moms Study. This study is a journaling-based intervention study that collects detailed data and biologic samples. It will help researchers to understand whether expressive writing can alleviate prenatal stress and improve birth outcomes in high risk pregnancies.
Why am I being asked to participate?
You are being asked to be in the study because you may be at a high risk for adverse pregnancy outcomes and meet eligibility criteria through the Perceived Stress Scale.
What will I have to do?
We will discuss the study with you in detail. If you agree to participate, you will review an online consent form and HIPAA form in detail.
Once you agree to participate and sign the consent form and the HIPAA form, you will fill out a series of surveys about medical history, pregnancy history, and psychosocial distress experiences. We will also collect samples of your blood and urine as well as vaginal swabs. This process will be repeated again during a regularly scheduled prenatal appointment between 24- and 28-weeks of gestation.
If you are assigned to the writing intervention group, you will be asked to respond to a prompt for 15-minutes in the provided journal/online once a week for 8 weeks.
We will obtain samples from the placenta/ umbilical cord, and cord blood after delivery (this tissue is normally discarded). 4 to 6 weeks after you deliver, we will ask you to complete a final round of surveys.
Your study timeline:
- Enrollment: up to 20 weeks – surveys + biological samples
- Weekly writing assignments at home
- 24-28 weeks appointment – surveys + biological samples
- Delivery: biological samples only
- 4-6 weeks postpartum – final round of surveys
We will collect all of your blood when you are having routine clinical blood work as ordered by your doctor.
There are no study-only visits to the hospital or clinic.
Are there any risks?
Study-related risks are low. There is a small chance of bruising, bleeding, or discomfort when we draw your blood, but there are no extra blood draws only for the study. Collecting the placenta and umbilical cord and cord blood occurs after delivery. The placenta is normally discarded after delivery. Every effort is made to protect your confidentiality.
If you experience emotional distress during this study and desire help, you may be referred to UNC psychological support services.
Will it cost me anything to be in the study?
There are no costs to participate.
Will I be paid to participate?
You will receive a $20 gift card or an equivalent value in parking passes for your time. Additionally, you will receive a tote bag, pen, and journal.
