NCT04203082

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

Feasibility and Limited Efficacy Trial of a Cognitive Behavioral Intervention to Reduce Procedural Anxiety Among Woman With High Risk Pregnancies With Scheduled Cesarean Deliveries

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-07-23
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2019-12-18
• Last updated: 2024-02-22

Locations

4 sites across 1 country: United States