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Completed

NCT Number: NCT04715724

Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior High Fidelity Simulation Training Patient Simulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LiquidGoldConcept

Ypsilanti, Michigan, 48197, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

LiquidGoldConcept

Industry

Collaborators

  • University of Michigan

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 20, 2021
Registry last updated
Apr 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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