Breastfeeding Clinical Trial
Official title:
Evaluation of Health Professional Learners' Competence in Newborn Positioning and Attachment Following a Standardized Patient-led Lactation Skills Workshop
NCT number | NCT04717128 |
Other study ID # | 21-002 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 28, 2021 |
Est. completion date | June 1, 2021 |
Verified date | March 2022 |
Source | LiquidGoldConcept |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 1, 2021 |
Est. primary completion date | February 4, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Enrollment in a health professional training program (e.g. medical student, nursing student, physician resident) Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
United States | LiquidGoldConcept | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
LiquidGoldConcept | Johns Hopkins University, Michigan State University, University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | (Pre-Intervention) Competence in Evaluating Newborn Positioning and Attachment | 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. | Day 1 (Pre-Intervention) | |
Primary | (Post-Intervention) Competence in Evaluating Newborn Positioning and Attachment | 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. | Day 1 (Post-Intervention) | |
Secondary | Performance of Clinical Lactation Skills related to positioning and attachment in a Video-based Simulation (Telesimulation) | The 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). | 1-12 weeks | |
Secondary | Performance of Clinical Lactation Skills related to positioning and attachment in a Video-based Simulation (Telesimulation) | An independent rater will watch audio-video recordings of the telesimulation and grade learner's completion of technical skills relevant to positioning and attachment according to a 14-point checklist (Point values: 0=did not complete, 1=did complete) | 1-12 weeks | |
Secondary | Satisfaction with the Breastfeeding Skills Workshop | Participants 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)
The skills workshop helped me prepare for the positioning and attachment telesimulation. The multiple-choice questions helped me prepare for the positioning and attachment telesimulation. What was expected of me as a health professional during the telesimulation was appropriate for my level of training. The amount of time allotted for the telesimulation was adequate. The standardized patient in the telesimulation was a realistic breastfeeding mother. The newborn simulator distracted from the realism of the telesimulation. |
1-12 weeks |
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