Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05316909 |
| Other study ID # |
21-003 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
January 1, 2021 |
Study information
| Verified date |
April 2022 |
| Source |
LiquidGoldConcept |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
