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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ after delivery, up to 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after delivery, up to 2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Childbirth Experience Questionnaire (CEQ)
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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,231 Previous Clinical Trials
1,001,763 Total Patients Enrolled
Joshua F Nitsche, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
1,125 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are in the final three months of pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Simulation Arm
- Group 2: Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age threshold for this clinical trial set at 55 or higher?
"Prospective patients must be aged 18 to 44 in order to enrol in this trial; however, there are 24 alternative trials for individuals younger than 18 and 88 additional ones for those over the age of 65."
Answered by AI
Are there any unfilled vacancies for participants in this research endeavor?
"This specific study, which was published in April of 2023 and updated last October has concluded its recruitment process. Despite this, there are still 135 other experiments actively seeking participants at the moment."
Answered by AI
Am I eligible to join this exploratory research project?
"Acceptance into this medical trial is limited to expecting mothers within the age range 18-44. There are 50 slots available for enrolment."
Answered by AI
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