Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment

April 2, 2021 updated by: LiquidGoldConcept

Evaluation and Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment in a Clinical Lactation Telesimulation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

  • n/a

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: 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)
ACTIVE_COMPARATOR: 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.
Other: 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)
ACTIVE_COMPARATOR: Static baby doll
In this arm, participants will complete a simulation using a rigid, plastic baby with a static, open mouth.
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Skills Confirmation
Time Frame: Day 1
Participants will confirm or deny whether they were able to teach specific components of newborn positioning and attachment with the baby doll.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative realism of baby doll
Time Frame: Day 1
Participants will be asked to compare the realism of the two baby dolls used in their simulation on a 30-point checklist. Respondent will rank the two baby dolls' ability to demonstrate specific components of positioning and attachment.
Day 1
Satisfaction with baby dolls
Time Frame: Day 1
Participants will participate in a 10-minute semi-structured interview immediately following the simulations and discuss what worked and didn't work about each baby doll for teaching newborn positioning and attachment. Interviews will be transcribed and thematically analyzed to report participant satisfaction/dissatisfaction with the baby dolls.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LiquidGoldConcept

Collaborators

University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2021

Primary Completion (ACTUAL)

February 15, 2021

Study Completion (ACTUAL)

April 1, 2021

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 18, 2021

First Posted (ACTUAL)

January 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 21-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be aggregated for data analysis and publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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