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Patient Centered Simulation For Labor and Delivery

Patient Centered Simulation For Labor and Delivery

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03654079
Enrollment
50
Registered
2018-08-31
Start date
2027-01-01
Completion date
2027-11-01
Last updated
2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related

Keywords

Simulation, Pregnancy, Labor and Delivery, Childbirth

Brief summary

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.

Detailed description

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. Women in Centering Pregnancy groups will be approached and assigned to either the intervention or control arm by Centering Pregnancy group. Those in the intervention arm will participate in simulations in the following areas: 1) In-Utero Resuscitation Simulation: the process that may occur if a baby has a significant drop in heart rate during labor, 2) Cesarean Section Simulation: the process of moving from the labor bed to the transport stretcher and on to the operating room in the event that a laboring woman needs a cesarean delivery, 3) Pushing Simulation: the pushing process after a laboring woman becomes completely dilated. Those in the control arm will not receive this education. All patient will complete a modified Childbirth Experience Questionnaire the day after delivery. Responses will be compared between the woman that participated in the simulations to women who did not participate in simulations.

Interventions

OTHERSimulation

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

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

Group assignment will be removed from the data set prior to analysis.

Intervention model description

Women in Centering Pregnancy groups at Wake Forest School of Medicine's Obstetrics (OB) and Gynecology (GYN) department will be recruited and sequentially assigned to participate in simulations or serve as controls.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No

Inclusion criteria

* Nulliparous pregnant women * In third trimester

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Childbirth Experience Questionnaire (CEQ)After delivery, up to 2 weeksChildbirth Experience Satisfaction will be measured by the CEQ a 24 item questionnaire. For 19 of the items the response format is a 4-point Likert Scale and three of the items are assessed using a visual analogue scale (VAS). The VAS-scales scores were transformed to categorical values, 0-40 = 1, 41-60 = 2, 61-80 = 3 and 81-100 = 4. Total score 24-92. Higher scores indicate better childbirth experience

Countries

United States

Contacts

CONTACTJoshua F Nitsche, MD
jnitsche@wakehealth.edu336-716-4304
PRINCIPAL_INVESTIGATORJoshua F Nitsche, MD

Wake Forest University Health Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026