Recruiting

Cognitive Behavioral Intervention

Sponsor:

University of Colorado, Denver

Code:

NCT04203082

Conditions

Procedural Anxiety

High Risk Pregnancy

Fetal Complications

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Exposure Intervention

Usual Care

Study Details

Brief summary:

The goals of this study are to determine the feasibility and efficacy of a brief, single-session cognitive-behavioral intervention for reducing preoperative and postoperative anxiety and for determining satisfaction with the delivery process in pregnant women scheduled for Cesarean delivery due to complications with their pregnancy. This will be done through a combination of psychoeducation and exposure therapy, where the participants will be walked through the steps of a Cesarean delivery in an operating room that mimics where the patient would actually be delivering. Follow-up will occur during the immediate and extended postpartum periods to determine satisfaction and levels of anxiety.

Conditions

Procedural Anxiety

High Risk Pregnancy

Fetal Complications

Study ID

NCT04203082

Start date

Jul 23, 2020

Status verified date

Feb, 2024

Completion date

Jan, 2025

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Fetal Anomaly/Complication
  • Planned Cesarean Delivery

Exclusion Criteria:

  • Delivery planned at outside hospital

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Exposure Intervention

Participants randomized to receive the Exposure Intervention will be scheduled to come to clinic for a 1-hour session for the intervention. During this time, they will receive psychoeducation and behavioral exposure to the Cesarean section procedure.

other: Usual Care

Participants randomized to the Care as Usual condition will receive the typical standard of care that is offered in the center. This involves the anesthesiologist meeting with the patient during a delivery planning meeting to provide patients with the opportunity to review anesthetic technique and ask questions.

Interventions

Exposure Intervention

Single session intervention of psychoeducation + exposure treatment to the operating room and procedural steps of a cesarean delivery

Usual Care

Standard of care for education about the cesarean /delivery planning varies across the two hospitals. At Children's Hospital Colorado, anesthesiologists are included in the delivery planning meetings where the patients have the opportunity to review anesthetic technique and ask questions.

Primary outcome measure

  • Acceptability: questionnaire [ Time Frame: < 14 days post-delivery ]
  • Demand [ Time Frame: < 14 days post-delivery ]
  • Practicality [ Time Frame: 1-2 weeks pre-delivery ]
  • Anxiety [ Time Frame: 3-4 weeks pre-delivery ]
  • Anxiety [ Time Frame: At Delivery ]
  • Anxiety [ Time Frame: 6-8 weeks post-delivery ]
  • Preoperative Anxiety [ Time Frame: At Delivery ]
  • Satisfaction with Delivery: questionnaire [ Time Frame: <14 days post-delivery ]
  • Post-Traumatic Stress Symptoms [ Time Frame: 6-8 weeks post-delivery ]

Central Contacts and Locations

Central contacts

Allison Dempsey, PhD

303-724-4401allison.dempsey@cuanschutz.edu

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Caitlin Sutton, MD

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Alice L O'Brien, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Feb 22, 2024

Last verified

Feb, 2024

Keywords

  • cesarean

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-02-22.