Childbirth Simulation for Reducing Fear in Pregnancy

Overseen By Joshua F Nitsche, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Not delivering at Wake Forest

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether simulating childbirth experiences can reduce fear and anxiety in pregnant women. Participants will experience simulations of common labor events, such as in-utero experiences, C-sections, and the pushing phase, to determine if these simulations help them feel more prepared and less fearful. The study seeks women who are pregnant for the first time and are in their third trimester. This research aims to improve childbirth experiences by reducing fear, potentially leading to better health outcomes for both mother and child. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance childbirth experiences for future mothers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this simulation is safe for reducing fear in pregnancy?

Research has shown that simulation-based training is safe and often yields positive results. Studies have found that simulations enhance skills and improve the safety of medical care. For instance, simulations in childbirth care have been linked to better teamwork and fewer errors. These practice scenarios help healthcare teams perform more effectively, leading to safer and more efficient care.

Simulations are widely used in medical education and have been proven to increase knowledge and skills without causing harm. This method is well-accepted and has a strong safety record in both teaching and real-world healthcare settings. Therefore, participants in this study can feel assured that the simulation exercises are generally safe and designed to reduce fear and anxiety about childbirth. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about childbirth simulation because it offers a novel way to reduce fear during pregnancy. Unlike traditional methods like counseling or education classes, this approach uses realistic, hands-on simulations of childbirth scenarios, such as in-utero activities, cesarean sections, and the pushing process. This immersive experience can help expecting mothers feel more prepared and confident by providing a safe space to practice and understand childbirth, potentially leading to a more positive birthing experience.

What evidence suggests that this simulation is effective for reducing fear in pregnancy?

Research has shown that simulations in childbirth education can help reduce fear in pregnant women. In this trial, participants in the Simulation Arm will engage in simulations that imitate real-life birth situations, which have been shown to boost confidence and lower anxiety about labor. For instance, one study found that an 8-week program with these simulations effectively reduced fear of childbirth. Another study demonstrated that simulations made women feel more capable of handling labor. Overall, using simulations in prenatal education appears to help women feel more prepared and less afraid of giving birth. ^{6 7 8 9 10}

Who Is on the Research Team?

Joshua F Nitsche, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for first-time pregnant women in their third trimester who plan to deliver with Wake Forest School of Medicine OB/GYN. It's not open to those who don't intend to give birth at this facility.

Inclusion Criteria

Nulliparous pregnant women

You are in the final three months of pregnancy.

Exclusion Criteria

Not planning on delivering with Wake Forest School of Medicine OB/GYN

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm undergo simulations of in-utero resuscitation, cesarean section, and pushing processes

1-2 weeks

1-2 visits (in-person)

Control

Participants in the control arm do not receive any simulations

1-2 weeks

1 visit (in-person)

Follow-up

Participants complete the Childbirth Experience Questionnaire to assess satisfaction

Up to 2 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Simulation

Trial Overview The study tests whether simulating stressful labor experiences can reduce fear and anxiety about childbirth. Women will go through simulations that mimic common stressors during delivery.

How Is the Trial Designed?

Group I: Simulation Arm Active Control 1 Intervention

Subjects in this arm will participate in Interventions (In- Utero Simulation, Cesarean Section Simulation, and Pushing Simulation).

Group II: Control Arm Active Control 1 Intervention

Subjects in this arm will not participate in any simulations.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

The implementation of a shoulder dystocia simulation program across five academic medical centers has been shown to effectively reduce avoidable patient harm related to neonatal injuries, which are a significant source of liability claims.

Key factors for the successful rollout of the program included strong leadership involvement, administrative support from the insurer, consensus on the curriculum, and ongoing performance tracking, highlighting the importance of collaboration and resource allocation in improving patient safety practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a multicenter shoulder dystocia injury prevention program. Szymanski, L., Arnold, C., Vaught, AJ., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35963072/

Effects of an integrated childbirth education program to ... The 8-week integrated childbirth education intervention was effective in reducing the fear of childbirth in pregnant women.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40660971/

The effect of high-fidelity simulation based education on ... Conclusion: High-fidelity simulation-based birth education significantly improved childbirth self-efficacy and reduced fear of labour. These ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/02646838.2025.2528809?src=

The effect of high-fidelity simulation based education on ... Conclusion. High-fidelity simulation-based birth education significantly improved childbirth self-efficacy and reduced fear of labour. These results suggest ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06941493

Effect of Normal Birth Simulation and Podcast Training ... The aim of this study is to examine the effect of simulation and podcast education used in prenatal education on pregnant women's fear of childbirth, birth ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0266613822001899

Effects of an integrated childbirth education program to ... The 8-week integrated childbirth education intervention was effective in reducing the fear of childbirth in pregnant women.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11224887/

The impact of simulation-based training in medical education Numerous studies have demonstrated that Simulation improves clinical skills, enhances patient safety, and leads to better clinical outcomes ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876139924001415

Effects of simulation-based education on nursing students' ... In this study, we examined how simulation-based education impacted nursing students' knowledge, skills, and approaches to natural childbirth.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8094450/

Multi‐professional simulation‐based team training in obstetric ... Simulation‐based team training focuses on building a system that will anticipate errors, improve patient outcomes and the performance of obstetric care teams.

9. saferbirth.org saferbirth.org/aim-resources/aim-cornerstones/simulations/

Simulation and Drills for Patient Safety | AIM These resources were developed with these concepts in mind and to support implementation of patient safety bundles and other quality practices and tools.

10. nursingsimulation.org nursingsimulation.org/article/S1876-1399(24)00044-6/fulltext

Global Consensus Statement on Simulation-Based ... It is indisputable that simulation improves healthcare practices, such as central venous catheter placements, leading to a decrease in related ...