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Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04715724
Enrollment
124
Registered
2021-01-20
Start date
2021-02-01
Completion date
2021-04-01
Last updated
2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, High Fidelity Simulation Training, Patient Simulation

Brief summary

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.

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.

Interventions

OTHERPositioning 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)

Sponsors

University of Michigan
CollaboratorOTHER
LiquidGoldConcept
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Technical Skills ConfirmationDay 1Participants will confirm or deny whether they were able to teach specific components of newborn positioning and attachment with the baby doll.

Secondary

MeasureTime frameDescription
Relative realism of baby dollDay 1Participants 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.
Satisfaction with baby dollsDay 1Participants 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026