Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-04-01

Brief Summary

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In this baby doll comparison study, clinical lactation specialists will complete two back-to-back video-based simulations (telesimulations) focused on newborn positioning and attachment. Study participants will interact with a standardized patient educator (SP) wearing the Lactation Simulation Model and using two baby dolls in a randomized order.

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Detailed Description

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Identifying signs of effective newborn positioning and attachment is an essential skill for maternal-child care providers. No study has evaluated the effectiveness of commonly used baby dolls for teaching this skill. In this comparison study, clinical lactation specialists will be randomly assigned two baby dolls to evaluate in two back-to-back video-based simulations (telesimulations) with a standardized patient wearing the LiquidGoldConcept Lactation Simulation Model. Participants will complete a novel competency assessment using 3-second video clips to show specific components of positioning and attachment and evaluating whether any correction is needed and why or why not.

Conditions

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Breastfeeding Patient Simulation High Fidelity Simulation Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All participants will evaluate the Newborn Oral Assessment and Latch Simulator (NORALSim) and one of two other baby dolls: 1) a cloth doll with a puppet-style head where the user can control the opening and closing of the mouth, and 2) a rigid, plastic doll with a static open mouth. The order of presentation of the dolls between the two back-to-back simulations and the second baby doll will be randomized.

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participants will not be aware which baby doll they will be assessing prior to presentation within the simulation. Standardized patients (SP) will know which baby doll to present during the simulations, so they will not be masked. Following the simulation, the SP will indicate which dolls were used using a blinded numbering system that will be used for data analysis by investigators and outcomes assessors.

Study Groups

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Baby doll with remote controlled jaw

In this arm, participants will complete a simulation using the Newborn Oral Assessment and Latch Simulator (NORALSim), which is designed to look, feel, and weigh like a healthy human newborn. The NORALSim's jaw can be remotely operated by the user to demonstrate attachment at the breast.

Group Type EXPERIMENTAL

Positioning and Attachment video-based simulation (telesimulation)

Intervention Type OTHER

Participants will teach a standardized patient actor (SP) to position and attach the baby doll at the breast of the Lactation Simulation Model in a video-based simulation (telesimulation)

Baby doll with hand controlled jaw

In this arm, participants will complete a simulation using a cloth baby with a puppet-style jaw which can be opened and closed by the user to demonstrate attachment at the breast.

Group Type ACTIVE_COMPARATOR

Positioning and Attachment video-based simulation (telesimulation)

Intervention Type OTHER

Participants will teach a standardized patient actor (SP) to position and attach the baby doll at the breast of the Lactation Simulation Model in a video-based simulation (telesimulation)

Static baby doll

In this arm, participants will complete a simulation using a rigid, plastic baby with a static, open mouth.

Group Type ACTIVE_COMPARATOR

Positioning and Attachment video-based simulation (telesimulation)

Intervention Type OTHER

Participants will teach a standardized patient actor (SP) to position and attach the baby doll at the breast of the Lactation Simulation Model in a video-based simulation (telesimulation)

Interventions

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Positioning and Attachment video-based simulation (telesimulation)

Participants will teach a standardized patient actor (SP) to position and attach the baby doll at the breast of the Lactation Simulation Model in a video-based simulation (telesimulation)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Received IBCLC, CLC, FABM, or similar certification in clinical lactation
* At least 2 years professional experience with breastfeeding patients
* Work with lactating patients/clients at least monthly
* Work with positioning and attachment at least weekly