Effect of a Newborn Simulator's Fidelity on Nursing Students' Level of Engagement in a Clinical Lactation Encounter

Nursing students (N=32) will be randomized to begin period 1 in either a high-fidelity or low-fidelity simulated experience with a mock patient wearing a breast model and holding a newborn simulator and then cross over in period 2 to the opposite arm. Data on student satisfaction, engagement, self-efficacy, and performance and simulator fidelity will be collected via Qualtrics surveys (defined, 6-point Likert scale), written and oral reflection, audio-video recordings of clinical lactation encounter, and clinical lactation skills checklists and global performance ratings.

Nursing students in the accelerated master's program will be recruited while completing their required simulation coursework. A random number generator will be used to randomly assign students to a treatment arm. Investigators will require at least 8 students per arm (power 80%, alpha 5%). Investigators will recruit 32 students for two study dates to compare the high-fidelity LiquidGoldConcept products to two competitor products.

The Johns Hopkins School of Nursing and Simulation Center will be the only sites where human subjects research will be performed. The collaborating investigators (Drs. Debbie Busch, Joanne Silbert-Flagg, and Nancy Sullivan) have expertise in clinical lactation education and simulation. With the collaborating investigators LiquidGoldConcept has already completed pilot studies to establish the feasibility of our approach and validate the survey instruments.

Study Overview

• Status: Withdrawn
• Conditions: Breastfeeding; Education, Nursing
• Intervention / Treatment: Other: Breastfeeding Simulation

Detailed Description

This is a randomized cluster design intervention. Assuming an enrollment ratio of 1, alpha of 0.05, beta of 0.2, investigators will recruit at least 8 students per arm with 16 students in the NORALSim arm and 16 students low-fidelity newborn simulator arm. A random number generator will be used to assign students to a study ID number (1-32). Students will be randomly assigned to a group of four a priori by assigning each student a number between 1 and 4. Three mock patients will be randomized a priori to minimize the confounding effect of a mock patient's acting abilities. Approximate start times are as follows: Groups 1 and 2 will begin at 8:30AM, Groups 3 and 4 will begin at 10AM, Groups 5 and 6 will begin at 1pm, and groups 7 and 8 will begin at 2:30pm. Investigators will alternate the order of the low-fidelity simulators (Lactessa or NeoNatalie) and randomize that order a priori such that 8 students (2 groups) will interact with the Lactessa and another 8 students (2 groups) will interact with Neonatalie.

In Period 1, one group will begin a simulated session with the NORALSim and the second group will begin with either the Mother's Own Milk Lactessa or Laerdal NeoNatalie, depending on the study date. Baseline level of breastfeeding experience and clinical lactation skills self-efficacy will be collected. Nursing students will teach a mock patient wearing the LSM and holding a newborn simulator how to position and attach the newborn at the breast and identify effective breastfeeding by differentiating between suckling patterns. In Period 2, each group will crossover to complete the same session with a different newborn simulator. After Period 1, each group will debrief to discuss their performance and engagement and use a Qualtrics survey (6-point Likert scale) to rate satisfaction, engagement, simulator fidelity, and self-efficacy. The same quantitative and qualitative data collection protocol will follow Period 2. All study activities will be audio-video recorded. JHU investigators will view the recorded encounters and assign a performance score using a skills checklist and global performance rating scale. Within a month, students will view their clinical encounters recording and complete a self-reflection to describe moments of engagement or disengagement. Students will also report any breastfeeding experience obtained since the intervention, score their performance, and complete the self-efficacy survey.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • LiquidGoldConcept

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Student enrolled at Johns Hopkins University School of Nursing

Exclusion Criteria:

• Younger than 18
• Not able to complete study activities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baby doll with remote controlled jaw; In this arm, standardized patients will use the Newborn Oral Assessment and Latch Simulator (NORALSim) to demonstrate and teach newborn positioning and attachment in the simulation.	Other: Breastfeeding Simulation; In Period 1, one group will begin a simulated session with the NORALSim and the second group will begin with either the Mother's Own Milk Lactessa or Laerdal NeoNatalie, depending on the study date. Baseline level of breastfeeding experience and clinical lactation skills self-efficacy will be collected. Nursing students will teach a mock patient wearing the LSM and holding a newborn simulator how to position and attach the newborn at the breast and identify effective breastfeeding by differentiating between suckling patterns. In Period 2, each group will crossover to complete the same session with a different newborn simulator. After Period 1, each group will debrief to discuss their performance and engagement and use a Qualtrics survey (6-point Likert scale) to rate satisfaction, engagement, simulator fidelity, and self-efficacy. The same quantitative and qualitative data collection protocol will follow Period 2.
Active Comparator: Standard care/doll; In this arm, standardized patients will use a cloth doll/standard treatment to demonstrate and teach newborn positioning and attachment in the breastfeeding skills workshop.	Other: Breastfeeding Simulation; In Period 1, one group will begin a simulated session with the NORALSim and the second group will begin with either the Mother's Own Milk Lactessa or Laerdal NeoNatalie, depending on the study date. Baseline level of breastfeeding experience and clinical lactation skills self-efficacy will be collected. Nursing students will teach a mock patient wearing the LSM and holding a newborn simulator how to position and attach the newborn at the breast and identify effective breastfeeding by differentiating between suckling patterns. In Period 2, each group will crossover to complete the same session with a different newborn simulator. After Period 1, each group will debrief to discuss their performance and engagement and use a Qualtrics survey (6-point Likert scale) to rate satisfaction, engagement, simulator fidelity, and self-efficacy. The same quantitative and qualitative data collection protocol will follow Period 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Engagement	The primary outcome is the level of engagement. A level of engagement score will be calculated from one qualitative and three quantitative criteria: 1) student self-reported perception of engagement during debriefing and self-reflection (qualitative), 2) time to task completion in both periods (quantitative, defined 6-point Likert scale in Qualtrics survey), 3) engagement survey score after both periods (quantitative, defined 6-point Likert scale in Qualtrics survey), and 4) global performance ratings by JHU faculty and students (quantitative, 4-item, 8-points possible).	Immediately after intervention
Level of Engagement	The primary outcome is the level of engagement. A level of engagement score will be calculated from one qualitative and three quantitative criteria: 1) student self-reported perception of engagement during debriefing and self-reflection (qualitative), 2) time to task completion in both periods (quantitative, defined 6-point Likert scale in Qualtrics survey), 3) engagement survey score after both periods (quantitative, defined 6-point Likert scale in Qualtrics survey), and 4) global performance ratings by JHU faculty and students (quantitative, 4-item, 8-points possible).	One Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with the simulation experience	Students' satisfaction after both periods (quantitative, defined 6-point Likert scale in Qualtrics survey)	Immediately after intervention
Self-Efficacy in clinical lactation/breastfeeding skills	Student self-efficacy in clinical lactation skills (quantitative, defined 6-point Likert scale in Qualtrics survey).	Immediately after intervention
Student performance of breastfeeding skills	Student performance (in both periods) using clinical lactation skills checklist and global performance rating	Immediately after intervention

Collaborators and Investigators

• Sponsor: LiquidGoldConcept

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 21-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Researchers do not plan to share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No