Breastfeeding Clinical Trial
Official title:
Evaluation and Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment in a Clinical Lactation Telesimulation
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 |
Verified date | April 2021 |
Source | LiquidGoldConcept |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | LiquidGoldConcept | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
LiquidGoldConcept | University of Michigan |
United States,
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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