Skip to content

Evaluation of Health Professional Learners' Competence in Newborn Positioning and Attachment Following a Standardized Patient-led Lactation Skills Workshop

Evaluation of Health Professional Learners' Competence in Newborn Positioning and Attachment Following a Standardized Patient-led Lactation Skills Workshop

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04717128
Enrollment
50
Registered
2021-01-20
Start date
2021-01-28
Completion date
2021-06-01
Last updated
2022-03-02

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

Conditions

Breastfeeding, Patient Simulation

Brief summary

Evaluating newborn positioning and attachment is a key skill for maternal-child healthcare providers. Trainees have limited opportunities to practice this skill in their clinical rotations due to a lack of access to lactating patients. Thus, positioning and attachment training is traditionally conducted through passive modalities, primarily videos. Investigators aim to evaluate the impact of an interactive breastfeeding skills workshop using a baby doll on health professional learners' ability to identify effective and ineffective positioning and attachment at the breast.

Detailed description

Faculty at the University of Michigan School of Public Health (UM-SPH), Johns Hopkins School of Nursing (JHUSON), and Michigan State University (MSU) are collaborating with LiquidGoldConcept (LGC), a company focusing on simulation-based training in maternal-child care, to evaluate the impact of high-fidelity simulation on health professional learner outcomes. For the Phase I SBIR, LGC is developing a high-fidelity newborn simulator for healthcare professional education in clinical lactation. Evaluating newborn positioning and attachment is a key skill for maternal-child healthcare providers. Trainees have limited opportunities to practice this skill in their clinical rotations due to a lack of access to lactating patients. Thus, positioning and attachment training is traditionally conducted through passive modalities, primarily videos. Investigators aim to evaluate the impact of an interactive breastfeeding skills workshop using a baby doll on health professional learners' ability to identify effective and ineffective positioning and attachment at the breast.

Interventions

OTHERBreastfeeding Skills Workshop

Participants will complete the standardized patient-led breastfeeding skills workshop where they will learn breast massage techniques to alleviate plugged ducts and engorgement, hand expression of breast milk, effective breast pump use, and newborn positioning and attachment.

Sponsors

University of Michigan
CollaboratorOTHER
Michigan State University
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
LiquidGoldConcept
Lead SponsorINDUSTRY

Study design

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

Masking description

Standardized patients leading the workshop will know which baby doll they are using in the workshop. Participants will not know whether or not they are receiving treatment and investigators and data analysts will be blinded to the treatment.

Intervention model description

Participants will be cluster randomized to complete the standardized-patient led breastfeeding skills workshop with one of the baby dolls.

Eligibility

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

Inclusion criteria

* Enrollment in a health professional training program (e.g. medical student, nursing student, physician resident)

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
(Pre-Intervention) Competence in Evaluating Newborn Positioning and AttachmentDay 1 (Pre-Intervention)Participants will complete a pre-intervention knowledge check on newborn positioning and attachment prior to and immediately following the Breastfeeding Skills Workshop. The knowledge check will consist of 5 true-false questions. For each question, the participant will watch a 3-second clip of positioning and attachment and respond to the question True or False, I would recommend adjustments to this dyad's positioning and attachment. For each true/false question, participants will respond to a multiple-choice question with 4 options on why they would or would not make adjustments to the dyad.
(Post-Intervention) Competence in Evaluating Newborn Positioning and AttachmentDay 1 (Post-Intervention)Participants will complete a post-intervention knowledge check on newborn positioning and attachment prior to and immediately following the Breastfeeding Skills Workshop. The knowledge check will consist of 5 true-false questions. For each question, the participant will watch a 3-second clip of positioning and attachment and respond to the question True or False, I would recommend adjustments to this dyad's positioning and attachment. For each true/false question, participants will respond to a multiple-choice question with 4 options on why they would or would not make adjustments to the dyad.

Secondary

MeasureTime frameDescription
Performance of Clinical Lactation Skills related to positioning and attachment in a Video-based Simulation (Telesimulation)1-12 weeksThe Standardized Patient in that telesimulation will rate their performance of clinical and communication skills using a 10-item Formative Assessment Rubric (FAR). The FAR includes four I know statements rating clinical skills specific to the case scenario (e.g. I know why my nipples have been hurting when I breastfeed my baby).
Satisfaction with the Breastfeeding Skills Workshop1-12 weeksParticipants will complete a 6-item satisfaction survey immediately following completion of the second telesimulation with the following items. Participants will rate their agreement on a 6-point Likert scale (1=strongly disagree, 6=strongly agree) 1. The skills workshop helped me prepare for the positioning and attachment telesimulation. 2. The multiple-choice questions helped me prepare for the positioning and attachment telesimulation. 3. What was expected of me as a health professional during the telesimulation was appropriate for my level of training. 4. The amount of time allotted for the telesimulation was adequate. 5. The standardized patient in the telesimulation was a realistic breastfeeding mother. 6. The newborn simulator distracted from the realism of the telesimulation.

Countries

United States

Outcome results

None listed

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