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

NCT04203082 | Recruiting

• 1 other identifier: 19-1896
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

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

Keywords

cesarean

Outcome Measures

Primary Outcomes (9)

• Acceptability: questionnaire

  To determine the extent to which the intervention is judged as suitable to program recipients, acceptability will be measured with the following questions, which are similar to other research studies examining satisfaction with interventions in feasibility trials (e.g., Rabin, Pinto, Dunsiger, Nash, \& Trask, 2009): "In general, how satisfied were you with the information provided about the Cesarean delivery?" (1= not at all, 7 = very satisfied)

  < 14 days post-delivery

• Demand

  To determine the extent to which the intervention is likely to be used by the target population, demand will be measured with the following questions: "Would you recommend that other women undergoing Cesarean delivery receive this intervention?" (1= do not recommend at all, 7 = highly recommend)

  < 14 days post-delivery

• Practicality

  To determine the extent to which the intervention can be carried out in the high-risk obstetrics settings, for each institution, the following data will be monitored and reported: (a) proportion of patients enrolled to treatment who received the intervention; (b) reasons that the intervention was not received as intended (e.g., no clinician available, patient delivered prior to intervention, no OR available for session); (c) length of time of each intervention session.

  1-2 weeks pre-delivery

• Anxiety

  The State-Trait Anxiety Inventory (STAI, Spielberger, 1983) is the most frequently used scale of anxiety in research world-wide and is considered a standard according to the MacArthur Foundation. The self-report inventory consists of 20 items to assess state anxiety, and another 20 items to assess trait anxiety. These two parts differ in the item wording, in the response format (intensity vs. frequency), and in the instructions for how to respond. Both the state and trait versions will be administered at enrollment/baseline and the state version only will be given at subsequent assessments at which time points anxiety is measured (see procedures below for summary of time points).

  3-4 weeks pre-delivery

• Anxiety

  The State-Trait Anxiety Inventory (STAI, Spielberger, 1983) is the most frequently used scale of anxiety in research world-wide and is considered a standard according to the MacArthur Foundation. The self-report inventory consists of 20 items to assess state anxiety, and another 20 items to assess trait anxiety. These two parts differ in the item wording, in the response format (intensity vs. frequency), and in the instructions for how to respond. Both the state and trait versions will be administered at enrollment/baseline and the state version only will be given at subsequent assessments at which time points anxiety is measured (see procedures below for summary of time points).

  At Delivery

• Anxiety

  The State-Trait Anxiety Inventory (STAI, Spielberger, 1983) is the most frequently used scale of anxiety in research world-wide and is considered a standard according to the MacArthur Foundation. The self-report inventory consists of 20 items to assess state anxiety, and another 20 items to assess trait anxiety. These two parts differ in the item wording, in the response format (intensity vs. frequency), and in the instructions for how to respond. Both the state and trait versions will be administered at enrollment/baseline and the state version only will be given at subsequent assessments at which time points anxiety is measured (see procedures below for summary of time points).

  6-8 weeks post-delivery

• Preoperative Anxiety

  Preoperative anxiety will be measured using the Visual Analogue Scale (VAS). The VAS has been validated to measure anxiety in the moment. Participants quantify their anxiety in the moment by marking on a visual analogue scale of 0-100 mm. One end of the scale is labelled as 'no anxiety' and the other end as 'maximum anxiety imaginable''.

  At Delivery

• Satisfaction with Delivery: questionnaire

  Satisfaction with delivery will be measured using the Maternal Satisfaction Scale for Cesarean section (MSSCS). The 22-item questionnaire yields a total satisfaction score, as well as subscale scores for satisfaction with anesthesia, insertion of needle, side effects, and atmosphere of the OR (including facilitating comfort, communication with providers, freedom to interact with partner, etc). All items are rated on a 7-point scale (1 = strongly disagree, 7 = strongly agree) with higher scores indicating better satisfaction. This will be administered at immediate postpartum.

  <14 days post-delivery

• Post-Traumatic Stress Symptoms

  Post-traumatic stress symptoms in relation to the delivery will be measured in the extended post-partum period using the Impact of Event Scale - Revised (IES-R).

  6-8 weeks post-delivery

Study Arms (2)

Exposure Intervention

EXPERIMENTAL

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.

Behavioral: Exposure Intervention

Usual Care

OTHER

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.

Other: Usual Care

Interventions

Exposure Intervention BEHAVIORAL

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

Exposure Intervention

Usual Care 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.

Usual Care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Enrollment will only be offered to pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Fetal Anomaly/Complication
• Planned Cesarean Delivery

You may not qualify if:

• Delivery planned at outside hospital

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (4)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Children's Mercy

Kansas City, Missouri, 64108, United States

WITHDRAWN

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Related Publications (7)

• 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].

  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.

  PMID: 27188222 BACKGROUND

• 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.

  PMID: 16256338 BACKGROUND

• 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.

  PMID: 25948900 BACKGROUND

• 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.

  PMID: 27824771 BACKGROUND

• 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.

  PMID: 26138522 BACKGROUND

• 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.

  PMID: 15321585 BACKGROUND

Study Officials

• Allison Dempsey, PhD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Dempsey, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: July 23, 2020
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)