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Effect of a Newborn Simulator's Fidelity on Nursing Students' Level of Engagement in a Clinical Lactation Encounter

2022년 4월 6일 업데이트: LiquidGoldConcept

Nursing students (N=32) will be randomized to begin period 1 in either a high-fidelity or low-fidelity simulated experience with a mock patient wearing a breast model and holding a newborn simulator and then cross over in period 2 to the opposite arm. Data on student satisfaction, engagement, self-efficacy, and performance and simulator fidelity will be collected via Qualtrics surveys (defined, 6-point Likert scale), written and oral reflection, audio-video recordings of clinical lactation encounter, and clinical lactation skills checklists and global performance ratings.

Nursing students in the accelerated master's program will be recruited while completing their required simulation coursework. A random number generator will be used to randomly assign students to a treatment arm. Investigators will require at least 8 students per arm (power 80%, alpha 5%). Investigators will recruit 32 students for two study dates to compare the high-fidelity LiquidGoldConcept products to two competitor products.

The Johns Hopkins School of Nursing and Simulation Center will be the only sites where human subjects research will be performed. The collaborating investigators (Drs. Debbie Busch, Joanne Silbert-Flagg, and Nancy Sullivan) have expertise in clinical lactation education and simulation. With the collaborating investigators LiquidGoldConcept has already completed pilot studies to establish the feasibility of our approach and validate the survey instruments.

연구 개요

상세 설명

This is a randomized cluster design intervention. Assuming an enrollment ratio of 1, alpha of 0.05, beta of 0.2, investigators will recruit at least 8 students per arm with 16 students in the NORALSim arm and 16 students low-fidelity newborn simulator arm. A random number generator will be used to assign students to a study ID number (1-32). Students will be randomly assigned to a group of four a priori by assigning each student a number between 1 and 4. Three mock patients will be randomized a priori to minimize the confounding effect of a mock patient's acting abilities. Approximate start times are as follows: Groups 1 and 2 will begin at 8:30AM, Groups 3 and 4 will begin at 10AM, Groups 5 and 6 will begin at 1pm, and groups 7 and 8 will begin at 2:30pm. Investigators will alternate the order of the low-fidelity simulators (Lactessa or NeoNatalie) and randomize that order a priori such that 8 students (2 groups) will interact with the Lactessa and another 8 students (2 groups) will interact with Neonatalie.

In Period 1, one group will begin a simulated session with the NORALSim and the second group will begin with either the Mother's Own Milk Lactessa or Laerdal NeoNatalie, depending on the study date. Baseline level of breastfeeding experience and clinical lactation skills self-efficacy will be collected. Nursing students will teach a mock patient wearing the LSM and holding a newborn simulator how to position and attach the newborn at the breast and identify effective breastfeeding by differentiating between suckling patterns. In Period 2, each group will crossover to complete the same session with a different newborn simulator. After Period 1, each group will debrief to discuss their performance and engagement and use a Qualtrics survey (6-point Likert scale) to rate satisfaction, engagement, simulator fidelity, and self-efficacy. The same quantitative and qualitative data collection protocol will follow Period 2. All study activities will be audio-video recorded. JHU investigators will view the recorded encounters and assign a performance score using a skills checklist and global performance rating scale. Within a month, students will view their clinical encounters recording and complete a self-reflection to describe moments of engagement or disengagement. Students will also report any breastfeeding experience obtained since the intervention, score their performance, and complete the self-efficacy survey.

연구 유형

중재적

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Michigan
      • Ypsilanti, Michigan, 미국, 48197
        • LiquidGoldConcept

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Student enrolled at Johns Hopkins University School of Nursing

Exclusion Criteria:

  • Younger than 18
  • Not able to complete study activities

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Baby doll with remote controlled jaw
In this arm, standardized patients will use the Newborn Oral Assessment and Latch Simulator (NORALSim) to demonstrate and teach newborn positioning and attachment in the simulation.
In Period 1, one group will begin a simulated session with the NORALSim and the second group will begin with either the Mother's Own Milk Lactessa or Laerdal NeoNatalie, depending on the study date. Baseline level of breastfeeding experience and clinical lactation skills self-efficacy will be collected. Nursing students will teach a mock patient wearing the LSM and holding a newborn simulator how to position and attach the newborn at the breast and identify effective breastfeeding by differentiating between suckling patterns. In Period 2, each group will crossover to complete the same session with a different newborn simulator. After Period 1, each group will debrief to discuss their performance and engagement and use a Qualtrics survey (6-point Likert scale) to rate satisfaction, engagement, simulator fidelity, and self-efficacy. The same quantitative and qualitative data collection protocol will follow Period 2.
활성 비교기: Standard care/doll
In this arm, standardized patients will use a cloth doll/standard treatment to demonstrate and teach newborn positioning and attachment in the breastfeeding skills workshop.
In Period 1, one group will begin a simulated session with the NORALSim and the second group will begin with either the Mother's Own Milk Lactessa or Laerdal NeoNatalie, depending on the study date. Baseline level of breastfeeding experience and clinical lactation skills self-efficacy will be collected. Nursing students will teach a mock patient wearing the LSM and holding a newborn simulator how to position and attach the newborn at the breast and identify effective breastfeeding by differentiating between suckling patterns. In Period 2, each group will crossover to complete the same session with a different newborn simulator. After Period 1, each group will debrief to discuss their performance and engagement and use a Qualtrics survey (6-point Likert scale) to rate satisfaction, engagement, simulator fidelity, and self-efficacy. The same quantitative and qualitative data collection protocol will follow Period 2.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Level of Engagement
기간: Immediately after intervention
The primary outcome is the level of engagement. A level of engagement score will be calculated from one qualitative and three quantitative criteria: 1) student self-reported perception of engagement during debriefing and self-reflection (qualitative), 2) time to task completion in both periods (quantitative, defined 6-point Likert scale in Qualtrics survey), 3) engagement survey score after both periods (quantitative, defined 6-point Likert scale in Qualtrics survey), and 4) global performance ratings by JHU faculty and students (quantitative, 4-item, 8-points possible).
Immediately after intervention
Level of Engagement
기간: One Month
The primary outcome is the level of engagement. A level of engagement score will be calculated from one qualitative and three quantitative criteria: 1) student self-reported perception of engagement during debriefing and self-reflection (qualitative), 2) time to task completion in both periods (quantitative, defined 6-point Likert scale in Qualtrics survey), 3) engagement survey score after both periods (quantitative, defined 6-point Likert scale in Qualtrics survey), and 4) global performance ratings by JHU faculty and students (quantitative, 4-item, 8-points possible).
One Month

2차 결과 측정

결과 측정
측정값 설명
기간
Satisfaction with the simulation experience
기간: Immediately after intervention
Students' satisfaction after both periods (quantitative, defined 6-point Likert scale in Qualtrics survey)
Immediately after intervention
Self-Efficacy in clinical lactation/breastfeeding skills
기간: Immediately after intervention
Student self-efficacy in clinical lactation skills (quantitative, defined 6-point Likert scale in Qualtrics survey).
Immediately after intervention
Student performance of breastfeeding skills
기간: Immediately after intervention
Student performance (in both periods) using clinical lactation skills checklist and global performance rating
Immediately after intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2021년 1월 1일

기본 완료 (예상)

2021년 1월 1일

연구 완료 (예상)

2021년 1월 1일

연구 등록 날짜

최초 제출

2022년 3월 18일

QC 기준을 충족하는 최초 제출

2022년 4월 6일

처음 게시됨 (실제)

2022년 4월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 4월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 4월 6일

마지막으로 확인됨

2022년 4월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 21-003

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

IPD 계획 설명

Researchers do not plan to share IPD with other researchers.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

3
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