High Risk Pregnancy Clinical Trial
Official title:
Feasibility and Limited Efficacy Trial of a Cognitive Behavioral Intervention to Reduce Procedural Anxiety Among Woman With High Risk Pregnancies With Scheduled Cesarean Deliveries
NCT number | NCT04203082 |
Other study ID # | 19-1896 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 23, 2020 |
Est. completion date | January 2025 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | January 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Fetal Anomaly/Complication - Planned Cesarean Delivery Exclusion Criteria: - Delivery planned at outside hospital |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Colorado | Aurora | Colorado |
United States | Baylor College of Medicine | Houston | Texas |
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
United States | Children's Mercy | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
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].
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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