Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment

NCT04715724 | Completed

• 1 other identifier: 21-001
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding; Patient Simulation; High Fidelity Simulation Training

Outcome Measures

Primary Outcomes (1)

• Technical Skills Confirmation

  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 Outcomes (2)

• Relative realism of baby doll

  Day 1

• Satisfaction with baby dolls

  Day 1

Study Arms (3)

Baby doll with remote controlled jaw

EXPERIMENTAL

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)

Baby doll with hand controlled jaw

ACTIVE COMPARATOR

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)

Static baby doll

ACTIVE COMPARATOR

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)

Interventions

Positioning and Attachment video-based simulation (telesimulation) 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; Baby doll with remote controlled jaw; Static baby doll

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• n/a

Sponsors & Collaborators

• LiquidGoldConcept: lead
• University of Michigan: collaborator

Study Sites (1)

LiquidGoldConcept

Ypsilanti, Michigan, 48197, United States

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 20, 2021
• Study Start: February 1, 2021
• Primary Completion: February 15, 2021
• Study Completion: April 1, 2021
• Last Updated: April 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)