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Childbirth Simulation for Reducing Fear in Pregnancy

N/A
Waitlist Available
Led By Joshua F Nitsche, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after delivery, up to 2 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether scaring people about childbirth makes them less afraid of it.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the intervention involves simulation rather than medication, traditional side effects are not expected. However, participants may experience emotional distress or increased anxiety as a result of the simulations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after delivery, up to 2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and after delivery, up to 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Childbirth Experience Questionnaire (CEQ)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Simulation ArmActive Control1 Intervention
Subjects in this arm will participate in Interventions (In- Utero Simulation, Cesarean Section Simulation, and Pushing Simulation).
Group II: Control ArmActive Control1 Intervention
Subjects in this arm will not participate in any simulations.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,478,285 Total Patients Enrolled
Joshua F Nitsche, MDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
1,177 Total Patients Enrolled

Media Library

Simulation Clinical Trial Eligibility Overview. Trial Name: NCT03654079 — N/A
Pregnancy Research Study Groups: Simulation Arm, Control Arm
Pregnancy Clinical Trial 2023: Simulation Highlights & Side Effects. Trial Name: NCT03654079 — N/A
Simulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03654079 — N/A
~33 spots leftby Nov 2025
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