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
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
-
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Michigan
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Ypsilanti, Michigan, United States, 48197
- LiquidGoldConcept
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-
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.
|
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.
|
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.
|
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
Collaborators
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.