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

NCT05316909 | Withdrawn

• 1 other identifier: 21-003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breastfeeding; Education, Nursing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Satisfaction with the simulation experience

  Immediately after intervention

• Self-Efficacy in clinical lactation/breastfeeding skills

  Immediately after intervention

• Student performance of breastfeeding skills

  Immediately after intervention

Study Arms (2)

Baby doll with remote controlled jaw

EXPERIMENTAL

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

Standard care/doll

ACTIVE COMPARATOR

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

Interventions

Breastfeeding Simulation OTHER

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.

Baby doll with remote controlled jaw; Standard care/doll

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Student enrolled at Johns Hopkins University School of Nursing

You may not qualify if:

• Younger than 18
• Not able to complete study activities

Sponsors & Collaborators

• LiquidGoldConcept: lead

Study Sites (1)

LiquidGoldConcept

Ypsilanti, Michigan, 48197, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are unaware of their intervention assignment (order of dolls).
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Educational intervention with newborn simulators of varying fidelity

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 7, 2022
• Study Start: January 1, 2021
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)