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

NCT ID: NCT04203082

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-23
• Study Completion Date: 2025-01-31

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.

Detailed Description

Women with high-risk pregnancies due to fetal complications have a higher risk of stress than those with uncomplicated pregnancies. In Colorado, self-harm, which is related to mental health challenges, anxiety, and stress is the most common form of maternal mortality. Both the presence of maternal or fetal complications and the anticipation of a surgical procedure increase likelihood of anxiety, specifically perioperative anxiety, in patients. The presence of perioperative anxiety in pregnant woman is associated with higher reports of postoperative pain and lower maternal satisfaction with the delivery. Additionally, preoperative anxiety in surgical patients is associated with other physiological symptoms and complications, including increase heart rate, blood pressure, and temperature, sweating, nausea, and heightened sensory awareness (and need for pain medications), emotional recall of the birth as psychological traumatic, and increased risk for postpartum mood and anxiety disorders. State (perioperative) anxiety is elevated prior to procedure and are similar to other norms for general medical/surgical patients.

Educational and psychological interventions are recommended for adults with anxiety related to medical procedures. For mild, acute procedural anxiety, this includes education about the procedure, acknowledgement and normalization of any feelings of anxiety in the patient, and allowing opportunities to promote a sense of control during the procedure. For those with more intense anxiety, brief cognitive behavioral therapy is identified as effective treatment. Brief cognitive-behavioral therapy interventions typically involve some or all of the following components: psychoeducation (about the association between thoughts, behaviors, and emotions and how these relate specifically to the procedure), cognitive restructuring (developing self-statements that will reduce anxiety-inducing reactions during the procedure), in vivo exposure to the setting, and/or relaxation training. Among adult patients undergoing surgical procedures, brief cognitive behavioral therapy (CBT) (typically 4 1-hour sessions) has been associated with reduced symptoms of anxiety and depression immediately after intervention and weeks after, as well as shorter hospital stays. Additionally, even briefer interventions involving exposure therapy is efficacious for other medical-related phobias, such as dental phobia. Exposure treatment can be administered in a single, 60-minute session, but may need more sessions for intense anxiety. Finally, in those with severe anxiety who are not responsive to previous interventions, anxiolytic premedicant drugs are sometimes indicated, though can be associated with acute anterograde amnesia and drowsiness during the procedure, as well as need for increased neonatal resuscitation, as they easily cross the placenta. For this reason, the majority of women with anxiety typically decline use of these medications when offered.

Given the high prevalence of preoperative anxiety among women undergoing a cesarean delivery with maternal or fetal complications, identification of low-cost interventions to decrease anxiety and increase satisfaction with the delivery process is indicated. To date, there are no randomized control trials investigating brief cognitive behavioral interventions for elective cesarean sections. This study seeks to establish the feasibility and limited efficacy of a brief, single session intervention that combines psychoeducation and exposure treatment to reduce preoperative anxiety and satisfaction of the delivery process among women undergoing elective cesarean section

Conditions

Procedural Anxiety; High Risk Pregnancy; Fetal Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exposure Intervention

Intervention Type: BEHAVIORAL

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

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.

Group Type: OTHER

Usual Care

Intervention Type: OTHER

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.

Interventions

Exposure Intervention

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Fetal Anomaly/Complication
• Planned Cesarean Delivery

Exclusion Criteria

• Delivery planned at outside hospital

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allison Dempsey, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status: RECRUITING

Children's Mercy

Kansas City, Missouri, United States

Site Status: WITHDRAWN

Baylor College of Medicine

Houston, Texas, United States

Site Status: RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Allison Dempsey, PhD

Role: CONTACT

allison.dempsey@cuanschutz.edu

303-724-4401

Facility Contacts

Allison Dempsey, PhD

Role: primary

Becky Johnson

Role: primary

Alice O'Brien, MD

Role: primary

References

Choy, Y. Treatment of acute procedural anxiety in adults. UpToDate. Waltham, MA: UpToDate Inc. Available form: http://www. uptodate. com [Last accessed on 2017 Oct 01].

Reference Type: BACKGROUND

Hepp P, Hagenbeck C, Burghardt B, Jaeger B, Wolf OT, Fehm T, Schaal NK; MAGIC Group. Measuring the course of anxiety in women giving birth by caesarean section: a prospective study. BMC Pregnancy Childbirth. 2016 May 18;16:113. doi: 10.1186/s12884-016-0906-z.

Reference Type: BACKGROUND

PMID: 27188222 (View on PubMed)

Hobson JA, Slade P, Wrench IJ, Power L. Preoperative anxiety and postoperative satisfaction in women undergoing elective caesarean section. Int J Obstet Anesth. 2006 Jan;15(1):18-23. doi: 10.1016/j.ijoa.2005.05.008. Epub 2005 Oct 26.

Reference Type: BACKGROUND

PMID: 16256338 (View on PubMed)

Maheshwari D, Ismail S. Preoperative anxiety in patients selecting either general or regional anesthesia for elective cesarean section. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):196-200. doi: 10.4103/0970-9185.155148.

Reference Type: BACKGROUND

PMID: 25948900 (View on PubMed)

Metz TD, Rovner P, Hoffman MC, Allshouse AA, Beckwith KM, Binswanger IA. Maternal Deaths From Suicide and Overdose in Colorado, 2004-2012. Obstet Gynecol. 2016 Dec;128(6):1233-1240. doi: 10.1097/AOG.0000000000001695.

Reference Type: BACKGROUND

PMID: 27824771 (View on PubMed)

Wilson CJ, Mitchelson AJ, Tzeng TH, El-Othmani MM, Saleh J, Vasdev S, LaMontagne HJ, Saleh KJ. Caring for the surgically anxious patient: a review of the interventions and a guide to optimizing surgical outcomes. Am J Surg. 2016 Jul;212(1):151-9. doi: 10.1016/j.amjsurg.2015.03.023. Epub 2015 Jun 2.

Reference Type: BACKGROUND

PMID: 26138522 (View on PubMed)

Wyatt SS, Jones DA, Peach MJ, Gurrin L. Anxiety in patients having caesarean section under regional anaesthesia: a questionnaire and pilot study. Int J Obstet Anesth. 2001 Oct;10(4):278-83. doi: 10.1054/ijoa.2001.0866.

Reference Type: BACKGROUND

PMID: 15321585 (View on PubMed)

Other Identifiers

19-1896

Identifier Type: -

Identifier Source: org_study_id