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Cognitive Behavioral Intervention to Reduce Procedural Anxiety Among Woman With High Risk Pregnancies With Scheduled Cesarean Deliveries

NCT04203082 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-02-22

No results posted yet for this study

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

Interventions

BEHAVIORAL

Exposure Intervention

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

OTHER

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.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Allison Dempsey, PhD · Children's Hospital Colorado

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-23
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04203082 on ClinicalTrials.gov