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临床试验/NCT04715724
NCT04715724已完成不适用

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

LiquidGoldConcept1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2021年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
124
试验地点
1
主要终点
Technical Skills Confirmation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants will not be aware which baby doll they will be assessing prior to presentation within the simulation. Standardized patients (SP) will know which baby doll to present during the simulations, so they will not be masked. Following the simulation, the SP will indicate which dolls were used using a blinded numbering system that will be used for data analysis by investigators and outcomes assessors.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • 未提供

研究组 & 干预措施

Baby doll with remote controlled jaw

Experimental

In this arm, participants will complete a simulation using the Newborn Oral Assessment and Latch Simulator (NORALSim), which is designed to look, feel, and weigh like a healthy human newborn. The NORALSim's jaw can be remotely operated by the user to demonstrate attachment at the breast.

干预措施: Positioning and Attachment video-based simulation (telesimulation) (Other)

Baby doll with hand controlled jaw

Active Comparator

In this arm, participants will complete a simulation using a cloth baby with a puppet-style jaw which can be opened and closed by the user to demonstrate attachment at the breast.

干预措施: Positioning and Attachment video-based simulation (telesimulation) (Other)

Static baby doll

Active Comparator

In this arm, participants will complete a simulation using a rigid, plastic baby with a static, open mouth.

干预措施: Positioning and Attachment video-based simulation (telesimulation) (Other)

结局指标

主要结局

Technical Skills Confirmation

时间窗: Day 1

Participants will confirm or deny whether they were able to teach specific components of newborn positioning and attachment with the baby doll.

次要结局

  • Relative realism of baby doll(Day 1)
  • Satisfaction with baby dolls(Day 1)

研究者

发起方
LiquidGoldConcept
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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