Patient Centered Simulation For Labor and Delivery

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT03654079
Status
Not Yet Recruiting

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Conditions

  • Pregnancy Related

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 44 Years
Healthy Volunteers
Not accepted

Interventions

  • Simulation — OTHER
    Participants assigned to the intervention group will participate in the following simulations: 1) the process that may occur if a baby has a significant drop in heart rate during labor, 2) the process of moving from the labor bed to the transport stretcher and on to the operating room in the event that a woman needs a cesarean delivery, 3) the pushing process after a woman becomes completely dilated

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Dec 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Simulation Arm
    Subjects in this arm will participate in Interventions (In- Utero Simulation, Cesarean Section Simulation, and Pushing Simulation).
  • No Intervention: Control Arm
    Subjects in this arm will not participate in any simulations.

Primary Outcome Measure

Childbirth Experience Questionnaire (CEQ) [ Time Frame: After delivery, up to 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist Health Downtown Health PlazaWinston-SalemNorth Carolina27103
Joshua F Nitsche, MD
[email protected]
336-716-6489
Mariam S Gomaa, BA
[email protected]
Joshua F Nitsche, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Wake Forest Baptist Health Downtown Health Plaza· Winston-Salem, NC

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