Patient Centered Simulation For Labor and Delivery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorWake Forest University Health Sciences

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Nulliparous pregnant women

In third trimester

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Simulation

    Other intervention

    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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Simulation ArmActive comparator 1 intervention
Group B: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Childbirth Experience Questionnaire (CEQ)

Childbirth 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

Time frame
After delivery, up to 2 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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