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NCT04715724 Clinical Trial

Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment

Breastfeeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04715724
Other study ID # 21-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date April 1, 2021

Study information
Verified date April 2021
Source LiquidGoldConcept
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 124
Est. completion date April 1, 2021
Est. primary completion date February 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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)

Locations
Country Name City State
United States LiquidGoldConcept Ypsilanti Michigan

Sponsors (2)
Lead Sponsor Collaborator
LiquidGoldConcept University of Michigan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Relative realism of baby doll 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
Secondary Satisfaction with baby dolls 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
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