Cognitive behavioral intervention to ease anxiety for women with high-risk pregnancies undergoing cesarean deliveries
Feasibility and Limited Efficacy Trial of a Cognitive Behavioral Intervention to Reduce Procedural Anxiety Among Woman With High Risk Pregnancies With Scheduled Cesarean Deliveries
This study is testing a short therapy program to help women with high-risk pregnancies feel less anxious before and after their cesarean deliveries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 4 sites (Aurora, Colorado and 3 other locations) |
| Trial ID | NCT04203082 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and effectiveness of a brief cognitive-behavioral intervention designed to reduce preoperative and postoperative anxiety in women with high-risk pregnancies scheduled for cesarean deliveries. Participants will receive psychoeducation and exposure therapy, which includes a walkthrough of the cesarean delivery process in a simulated operating room environment. The study will assess anxiety levels and satisfaction with the delivery process during immediate and extended postpartum periods. By addressing anxiety, the study seeks to improve maternal satisfaction and reduce complications associated with high levels of stress.
Who should consider this trial
Good fit: Ideal candidates for this study are women with high-risk pregnancies due to fetal complications who are scheduled for a cesarean delivery.
Not a fit: Patients who are planning to deliver at a hospital outside of the study locations will not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce anxiety and improve satisfaction for women undergoing cesarean deliveries due to high-risk pregnancies.
How similar studies have performed: Previous studies have shown that cognitive-behavioral interventions can effectively reduce anxiety in surgical patients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fetal Anomaly/Complication * Planned Cesarean Delivery Exclusion Criteria: * Delivery planned at outside hospital
Where this trial is running
Aurora, Colorado and 3 other locations
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Children's Mercy — Kansas City, Missouri, United States (Withdrawn)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Allison Dempsey, PhD — Children's Hospital Colorado
- Study coordinator: Allison Dempsey, PhD
- Email: allison.dempsey@cuanschutz.edu
- Phone: 303-724-4401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.