Patient Centered Simulation For Labor and Delivery

NCT03654079 | Not Yet Recruiting

• 1 other identifier: IRB00052749
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

Simulation; Pregnancy; Labor and Delivery; Childbirth

Outcome Measures

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

  After delivery, up to 2 weeks

Study Arms (2)

Simulation Arm

ACTIVE COMPARATOR

Subjects in this arm will participate in Interventions (In- Utero Simulation, Cesarean Section Simulation, and Pushing Simulation).

Other: Simulation

Control Arm

NO INTERVENTION

Subjects in this arm will not participate in any simulations.

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

Simulation Arm

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: Only pregnant women are eligible for this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliparous pregnant women
• In third trimester

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health Downtown Health Plaza

Winston-Salem, North Carolina, 27103, United States

Location

Related Publications (5)

• Rudman A, El-Khouri B, Waldenstrom U. Women's satisfaction with intrapartum care - a pattern approach. J Adv Nurs. 2007 Sep;59(5):474-87. doi: 10.1111/j.1365-2648.2007.04323.x. Epub 2007 Jul 20.

  PMID: 17645495 BACKGROUND

• Nilver H, Begley C, Berg M. Measuring women's childbirth experiences: a systematic review for identification and analysis of validated instruments. BMC Pregnancy Childbirth. 2017 Jun 29;17(1):203. doi: 10.1186/s12884-017-1356-y.

  PMID: 28662645 BACKGROUND

• Nilsson C, Lundgren I, Karlstrom A, Hildingsson I. Self reported fear of childbirth and its association with women's birth experience and mode of delivery: a longitudinal population-based study. Women Birth. 2012 Sep;25(3):114-21. doi: 10.1016/j.wombi.2011.06.001. Epub 2011 Jul 20.

  PMID: 21764400 BACKGROUND

• World Health Organization . WHO Statment: The prevention and elimiation of disrespect and abuse during facility-based childbirth. 2014.

  BACKGROUND

• Finnbogason, Christine. "Experiences and Satisfaction with Intrapartum Care: A Comparison of Normal Weight Women and Obese Women." University of Manitoba, University of Manitoba, 2016, pp. 149-154.

  BACKGROUND

Study Officials

• Joshua F Nitsche, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua F Nitsche, MD

CONTACT

336-716-4304; jnitsche@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Group assignment will be removed from the data set prior to analysis.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 31, 2018
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)