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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Patient satisfaction is an important outcome in the evaluation and development of healthcare services. Studies have identified tools that successfully measure women's childbirth experiences, and have shown that multidimensional measures of women's satisfaction in labor and delivery provides a richer and diverse perspective on women's experiences of intrapartum care. Childbirth experience can have significant effects, both positive and negative, on women's immediate and long term health outcomes. Patients with negative experiences surrounding childbirth have been shown to have significant fear surrounding the labor and delivery experience that negatively impact subsequent deliveries. Often fear is worsened by a lack of knowledge of what to expect during labor. Women enrolled in this study will simulate some of the potentially stressful experiences that commonly occur during labor to determine if doing so decreases a woman's fear and anxiety about labor and delivery.

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 data supports the effectiveness of the treatment Simulation, Simulation-Based Learning, Medical Simulation, Clinical Simulation for reducing fear in pregnancy?

Research shows that simulation-based childbirth education can reduce fear of childbirth, as seen in a study with Chinese first-time mothers. Additionally, simulation training improves medical students' understanding and confidence in managing childbirth, suggesting it could help pregnant individuals feel more prepared and less fearful. ^{1 2 3 4 5}

Is simulation-based learning safe for use in childbirth education?

Simulation-based learning in childbirth education is generally considered safe and is used to improve skills, communication, and teamwork in obstetrics. It has been implemented in various programs to enhance patient safety and quality of care. ^{2 3 6 7 8}

How does the treatment Simulation differ from other treatments for reducing fear in pregnancy?

Simulation-based learning for reducing fear in pregnancy is unique because it uses realistic childbirth scenarios to help expectant mothers understand and manage their fears. Unlike traditional education methods, this approach allows participants to experience and practice childbirth in a controlled, safe environment, which can increase their confidence and reduce anxiety. ^{2 3 5 9 10}

Research Team

Joshua F Nitsche, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Additional training with an obstetric simulator improves medical student comfort with basic procedures. [2019]

2. Ireland pubmed.ncbi.nlm.nih.gov

Simulation-based childbirth education for Chinese primiparas: A pilot randomized controlled trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Teaching childbirth with high-fidelity simulation. Is it better observing the scenario during the briefing session? [2019]

4. England pubmed.ncbi.nlm.nih.gov

Simulation-based team training for multi-professional obstetric care teams to improve patient outcome: a multicentre, cluster randomised controlled trial. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Simulation of childbirth improves clinical management capacity and self-confidence in medical students. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Simulation in maternal-fetal medicine: making a case for the need. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Implementation of a multicenter shoulder dystocia injury prevention program. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Interdisciplinary collaboration to maintain a culture of safety in a labor and delivery setting. [2013]

9. Brazil pubmed.ncbi.nlm.nih.gov

Interdisciplinary simulation scenario in nursing education: Humanized childbirth and birth. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Development and evaluation of simulation-based training for obstetrical nursing using human patient simulators. [2019]