Premature Birth, Prenatal Stress
Conditions
Brief summary
The overall purpose of this study is to determine whether implementing a 'Prenatal Consult Bundle' to the existing prenatal consult, including provision of sample questions, added discussion points and handouts, and a return visit, will decrease parental anxiety and improve information recall. Additionally, this study will determine if this effect is further increased with the use of illustrated literature.
Detailed description
This study will be a prospective randomized control trial. Seventy participants will be enrolled for the 'Standard' consult. These women will receive a questionnaire 6-24 hours after their consult. Then 140 participants will be randomized to either the 'Standard Upgrade' or 'Illustrated Upgrade' arm. Randomization will additionally be stratified based on estimated gestational age. These participants will receive an upgraded consult implementing the 'Prenatal Consult Bundle' which emphasizes the parents' role and follow up, with or without an illustrated handout. These participants will receive the same questionnaire 6-24 hours after their consult. Demographic information collected will include maternal age, gravidity, use of magnesium, social support and health literacy. All data will be collected to assess whether either arm of the consult 'upgrade' reduces anxiety or improves knowledge retention after the prenatal consult. Analyses will be completed using Statistical Analysis Software (SAS) using appropriate statistical testing.
Interventions
OTHERIllustrated handout at prenatal consult
Illustrated consult group will be given an illustration paper describing the majority of the issues discussed at the prenatal consult
OTHERStandard Prenatal Consult
Standard prenatal consult
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women admitted to OB unit at the University of Virginia Medical Center * Estimated gestational age of \>25 weeks and \<35 weeks
Exclusion criteria
* Non-English Speaking * Pregnant women \<15 years of age * Known critical conditions or congenital anomalies * Women who have had any prior prenatal consultations regarding current pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Anxiety | Within 48 hours of consultation | Using the State-Trait Anxiety Inventory (STAI), maternal anxiety will be assessed between the two groups |
Countries
United States
Outcome results
None listed