Procedural AnxietyNCT04203082
Cognitive Behavioral Intervention to Reduce Procedural Anxiety Among Woman With High Risk Pregnancies With Scheduled Cesarean Deliveries
A study testing Exposure Intervention in people with Procedural Anxiety and High Risk Pregnancy, run by University of Colorado, Denver at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Procedural Anxiety, High Risk Pregnancy, Fetal Complications
- What is being tested?
- Exposure Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Jul 2020to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Fetal Anomaly/Complication
- Planned Cesarean Delivery
Who cannot join
- Delivery planned at outside hospital
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 3 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Allison Dempsey, PhD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Becky Johnson
Caitlin Sutton, MD
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Alice O'Brien, MD
Alice L O'Brien, MD
- Withdrawn
Children's Mercy
Kansas City, Missouri, 64108
About this study
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
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.
Read the 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
- Being tested
- Exposure Intervention, Usual Care
- Keywords
- cesarean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure InterventionBehavioural
Single session intervention of psychoeducation + exposure treatment to the operating room and procedural steps of a cesarean delivery
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: < 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)
Measured: < 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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''.
Measured: 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.
Measured: <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).
Measured: 6-8 weeks post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start23 Jul 2020
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Procedural AnxietyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Dempsey, PhD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203082
- Sponsor's protocol ID
- 19-1896
- Status last verified
- Feb 2024
- First submitted
- 16 Dec 2019
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27188222Hobson 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.
PubMed 16256338Maheshwari 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.
PubMed 25948900Metz 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.
PubMed 27824771Wilson 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.
PubMed 26138522Wyatt 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.
PubMed 15321585
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04203082
- Acronym / sponsor ID
- 19-1896
- Conditions
- Procedural Anxiety, High Risk Pregnancy, Fetal Complications
- Keywords
- cesarean
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure Intervention | Experimental | Behavioral: Exposure InterventionParticipants 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. |
| Usual Care | Other | Other: Usual CareParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Fetal Anomaly/Complication
- Planned Cesarean Delivery
Key exclusion criteria (1 listed)
- Delivery planned at outside hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure InterventionSingle session intervention of psychoeducation + exposure treatment to the operating room and procedural steps of a cesarean delivery | Behavioural | Exposure Intervention |
| Usual CareStandard 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. | Other | Usual Care |
Primary outcome
Acceptability: questionnaire
Time frame: < 14 days post-delivery
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)
Demand
Time frame: < 14 days post-delivery
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)
Practicality
Time frame: 1-2 weeks pre-delivery
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.
Anxiety
Time frame: 3-4 weeks pre-delivery
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).
Anxiety
Time frame: At Delivery
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).
Anxiety
Time frame: 6-8 weeks post-delivery
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).
Preoperative Anxiety
Time frame: At Delivery
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''.
Satisfaction with Delivery: questionnaire
Time frame: <14 days post-delivery
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.
Post-Traumatic Stress Symptoms
Time frame: 6-8 weeks post-delivery
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- BackgroundChoy, 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: PubMed 27188222Hepp 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.
- Background: PubMed 16256338Hobson 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.
- Background: PubMed 25948900Maheshwari 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.
- Background: PubMed 27824771Metz 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.
- Background: PubMed 26138522Wilson 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.
- Background: PubMed 15321585Wyatt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Dempsey, PhD principal investigator
Children's Hospital Colorado
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure Intervention in people with Procedural Anxiety and High Risk Pregnancy, run by University of Colorado, Denver at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allison Dempsey, PhD (303-724-4401, allison.dempsey@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability: questionnaire (time frame: < 14 days post-delivery). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04203082, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.