Trial Outcomes & Findings for The Impact of Pedagogical Framework in Education of Neonatal Resuscitation (NCT NCT04748341)

NCT ID: NCT04748341

Last Updated: 2021-05-18

Results Overview

knowledge is considering awareness of Neonatal resuscitation. It will be measured through a 17-item multiple-choice question adopted from Knowledge Question total score ranged from 0 to 17. A higher score means have more knowledge.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

62 participants

Primary outcome timeframe

before intervention and 6 weeks after intervention

Results posted on

2021-05-18

Participant Flow

initially, 62 participants (31 in each group) were recruited. one participant from each group was lost in follow-up due to some personal reasons. The final sample size remained 60 (30 in each group).

Two participants were dropped in the follow-up for personal reasons one was not attending the full course of intervention and the other was absent on the days of evaluation. Thus, yielding a total of 60 participants (30 in each group).

Participant milestones

Participant milestones
Measure
Traditional Group
Group A will be taught through the two steps traditional method (2 lectures/week + 1 skill lab/week). First, learn through didactic Lectures and then practice skills on the Mannequins. The educational lecture content will be the same for both groups. Traditional Method: The traditional method group learns through 2-step method. 1. didactic lectures on neonatal resuscitation were delivered. 2. Practice skill on mannequins
Pedagogical Group
Group B will learn through the 6-step method \[ 2 lectures/week + video + 2skill lab/week (1 session under instructor + 1 session for skill maintenance)\], learn skill, see the video on resuscitation, practice on simulator, prove through practice, observe skill on clinical rotation and lastly maintain it through clinical supplemented with simulation. Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain): The "Learn, See, Practice, Prove, Do, and Maintain" (LSPPDM) pedagogy is acting as a guiding path for educators in teaching and learning procedural skills. It is synthesized after intensely reviewing the literature comprises steps. In the 1st step, learners learn through didactic lectures, further proceeding to see procedural videos. The 3rd step, "Practice" expose learners to perform the skill on a simulator. In the 4th step "Prove" the learner proves the skill. The 5th step Do comprise real-life exposure through the clinical rotation. Then, finally the 6th step"Maintain" the learner maintains skill supplemented with simulation as needed.
Overall Study
STARTED
31
31
Overall Study
COMPLETED
30
30
Overall Study
NOT COMPLETED
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Traditional Group
Group A will be taught through the two steps traditional method (2 lectures/week + 1 skill lab/week). First, learn through didactic Lectures and then practice skills on the Mannequins. The educational lecture content will be the same for both groups. Traditional Method: The traditional method group learns through 2-step method. 1. didactic lectures on neonatal resuscitation were delivered. 2. Practice skill on mannequins
Pedagogical Group
Group B will learn through the 6-step method \[ 2 lectures/week + video + 2skill lab/week (1 session under instructor + 1 session for skill maintenance)\], learn skill, see the video on resuscitation, practice on simulator, prove through practice, observe skill on clinical rotation and lastly maintain it through clinical supplemented with simulation. Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain): The "Learn, See, Practice, Prove, Do, and Maintain" (LSPPDM) pedagogy is acting as a guiding path for educators in teaching and learning procedural skills. It is synthesized after intensely reviewing the literature comprises steps. In the 1st step, learners learn through didactic lectures, further proceeding to see procedural videos. The 3rd step, "Practice" expose learners to perform the skill on a simulator. In the 4th step "Prove" the learner proves the skill. The 5th step Do comprise real-life exposure through the clinical rotation. Then, finally the 6th step"Maintain" the learner maintains skill supplemented with simulation as needed.
Overall Study
Lost to Follow-up
1
1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Traditional Group
n=30 Participants
Group A will be taught through the two steps traditional method (2 lectures/week + 1 skill lab/week). First, learn through didactic Lectures and then practice skills on the Mannequins. The educational lecture content will be the same for both groups. Traditional Method: The traditional method group learns through 2-step method. 1. didactic lectures on neonatal resuscitation were delivered. 2. Practice skill on mannequins
Pedagogical Group
n=30 Participants
Group B will learn through the 5-step method \[ 2 lectures/week + video + 2skill lab/week (1 session under instructor + 1 session for skill maintenance)\], learn skill, see the video on resuscitation, practice on simulator, prove through practice, observe skill on clinical rotation and lastly maintain it through clinical supplemented with simulation. Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain): The "Learn, See, Practice, Prove, Do, and Maintain" (LSPPDM) pedagogy is acting as a guiding path for educators in teaching and learning procedural skills. It is synthesized after intensely reviewing the literature comprises steps. In the 1st step, learners learn through didactic lectures, further proceeding to see procedural videos. The 3rd step, "Practice" expose learners to perform the skill on a simulator. In the 4th step "Prove" the learner proves the skill. The 5th step Do comprise real-life exposure through the clinical rotation. Then, finally the 6th step"Maintain" the learner maintains skill supplemented with simulation as needed.
Total
n=60 Participants
Total of all reporting groups
Age, Continuous
22.3 years
STANDARD_DEVIATION 0.75 • n=30 Participants
21.9 years
STANDARD_DEVIATION 1.1 • n=30 Participants
22 years
STANDARD_DEVIATION 1.1 • n=60 Participants
Sex: Female, Male
Female
30 Participants
n=30 Participants
30 Participants
n=30 Participants
60 Participants
n=60 Participants
Sex: Female, Male
Male
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Year of Professional Education
3rd year
14 participants
n=30 Participants
15 participants
n=30 Participants
30 participants
n=60 Participants
Year of Professional Education
4th year
16 participants
n=30 Participants
15 participants
n=30 Participants
30 participants
n=60 Participants
Primary Language
Urdu
29 participants
n=30 Participants
29 participants
n=30 Participants
58 participants
n=60 Participants
Primary Language
Punjabi
1 participants
n=30 Participants
1 participants
n=30 Participants
2 participants
n=60 Participants
Marital Status
Unmarried
29 participants
n=30 Participants
30 participants
n=30 Participants
59 participants
n=60 Participants
Marital Status
Married
1 participants
n=30 Participants
0 participants
n=30 Participants
1 participants
n=60 Participants
Residential Area
Rural
3 participants
n=30 Participants
2 participants
n=30 Participants
5 participants
n=60 Participants
Residential Area
Urban
27 participants
n=30 Participants
28 participants
n=30 Participants
55 participants
n=60 Participants
Division in previous results
First
28 participants
n=30 Participants
30 participants
n=30 Participants
58 participants
n=60 Participants
Division in previous results
Second
2 participants
n=30 Participants
0 participants
n=30 Participants
2 participants
n=60 Participants
Previous neonatal resuscitation exposure
Yes
5 participants
n=30 Participants
3 participants
n=30 Participants
8 participants
n=60 Participants
Previous neonatal resuscitation exposure
No
25 participants
n=30 Participants
27 participants
n=30 Participants
52 participants
n=60 Participants

PRIMARY outcome

Timeframe: before intervention and 6 weeks after intervention

Population: All participants were randomly assigned to traditional and pedagogy groups. The analysis was done before and 6 weeks after the intervention.

knowledge is considering awareness of Neonatal resuscitation. It will be measured through a 17-item multiple-choice question adopted from Knowledge Question total score ranged from 0 to 17. A higher score means have more knowledge.

Outcome measures

Outcome measures
Measure
Traditional Group
n=30 Participants
Group A will be taught through the two steps traditional method (2 lectures/week + 1 skill lab/week). First, learn through didactic Lectures and then practice skills on the Mannequins. The educational lecture content will be the same for both groups. Traditional Method: The traditional method group learns through 2-step method. 1. didactic lectures on neonatal resuscitation were delivered. 2. Practice skill on mannequins
Pedagogical Group
n=30 Participants
Group B will learn through the 6-step method \[ 2 lectures/week + video + 2skill lab/week (1 session under instructor + 1 session for skill maintenance)\], learn skill, see the video on resuscitation, practice on simulator, prove through practice, observe skill on clinical rotation and lastly maintain it through clinical supplemented with simulation. Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain): The "Learn, See, Practice, Prove, Do, and Maintain" (LSPPDM) pedagogy is acting as a guiding path for educators in teaching and learning procedural skills. It is synthesized after intensely reviewing the literature comprises steps. In the 1st step, learners learn through didactic lectures, further proceeding to see procedural videos. The 3rd step, "Practice" expose learners to perform the skill on a simulator. In the 4th step "Prove" the learner proves the skill. The 5th step Do comprise real-life exposure through the clinical rotation. Then, finally the 6th step"Maintain" the learner maintains skill supplemented with simulation as needed.
Knowledge Questionnaire
before 6 weeks (pre data)
5.90 score on a scale
Standard Deviation 1.95
5.87 score on a scale
Standard Deviation 1.87
Knowledge Questionnaire
After 6 weeks (Post data)
9.97 score on a scale
Standard Deviation 1.22
13.33 score on a scale
Standard Deviation 1.30

PRIMARY outcome

Timeframe: before intervention and 6 weeks after intervention

Population: Participants were randomly assigned into traditional and pedagogy group and were analyzed two times before and 6 weeks after the intervention.

The SENR instrument is a 23-item scale that measured nursing students' perception of confidence in their capabilities in neonatal resuscitation. All SENR items were valued on a 10-point Likert scale. The total score ranged from 0 to 230. A higher score means have more self-efficacy.

Outcome measures

Outcome measures
Measure
Traditional Group
n=30 Participants
Group A will be taught through the two steps traditional method (2 lectures/week + 1 skill lab/week). First, learn through didactic Lectures and then practice skills on the Mannequins. The educational lecture content will be the same for both groups. Traditional Method: The traditional method group learns through 2-step method. 1. didactic lectures on neonatal resuscitation were delivered. 2. Practice skill on mannequins
Pedagogical Group
n=30 Participants
Group B will learn through the 6-step method \[ 2 lectures/week + video + 2skill lab/week (1 session under instructor + 1 session for skill maintenance)\], learn skill, see the video on resuscitation, practice on simulator, prove through practice, observe skill on clinical rotation and lastly maintain it through clinical supplemented with simulation. Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain): The "Learn, See, Practice, Prove, Do, and Maintain" (LSPPDM) pedagogy is acting as a guiding path for educators in teaching and learning procedural skills. It is synthesized after intensely reviewing the literature comprises steps. In the 1st step, learners learn through didactic lectures, further proceeding to see procedural videos. The 3rd step, "Practice" expose learners to perform the skill on a simulator. In the 4th step "Prove" the learner proves the skill. The 5th step Do comprise real-life exposure through the clinical rotation. Then, finally the 6th step"Maintain" the learner maintains skill supplemented with simulation as needed.
Self-efficacy for Neonatal Resuscitation (SENR)
After 6 weeks (Post data)
186.6 score on a scale
Standard Deviation 25.3
188.6 score on a scale
Standard Deviation 24.2
Self-efficacy for Neonatal Resuscitation (SENR)
Before 6 weeks (pre data)
96.1 score on a scale
Standard Deviation 35.5
95.9 score on a scale
Standard Deviation 37.6

PRIMARY outcome

Timeframe: before intervention and 6 weeks after intervention

Population: Participants were randomly assign into traditional and pedagogy group and were assessed for skill before and 6 weeks after the intervention.

A 30 items checklist will be used. Each of the correct actions was graded as 1=yes and for wrong action 0=no. The total score ranged from 0 to 30. The total score ranged from 0 to 30. A higher score means have more skill.

Outcome measures

Outcome measures
Measure
Traditional Group
n=30 Participants
Group A will be taught through the two steps traditional method (2 lectures/week + 1 skill lab/week). First, learn through didactic Lectures and then practice skills on the Mannequins. The educational lecture content will be the same for both groups. Traditional Method: The traditional method group learns through 2-step method. 1. didactic lectures on neonatal resuscitation were delivered. 2. Practice skill on mannequins
Pedagogical Group
n=30 Participants
Group B will learn through the 6-step method \[ 2 lectures/week + video + 2skill lab/week (1 session under instructor + 1 session for skill maintenance)\], learn skill, see the video on resuscitation, practice on simulator, prove through practice, observe skill on clinical rotation and lastly maintain it through clinical supplemented with simulation. Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain): The "Learn, See, Practice, Prove, Do, and Maintain" (LSPPDM) pedagogy is acting as a guiding path for educators in teaching and learning procedural skills. It is synthesized after intensely reviewing the literature comprises steps. In the 1st step, learners learn through didactic lectures, further proceeding to see procedural videos. The 3rd step, "Practice" expose learners to perform the skill on a simulator. In the 4th step "Prove" the learner proves the skill. The 5th step Do comprise real-life exposure through the clinical rotation. Then, finally the 6th step"Maintain" the learner maintains skill supplemented with simulation as needed.
Neonatal Resuscitation Checklist
Before intervention (pre data)
3.30 score on a scale
Standard Deviation 1.18
3.37 score on a scale
Standard Deviation 1.10
Neonatal Resuscitation Checklist
6 weeks after intervention (post data)
16.20 score on a scale
Standard Deviation 2.40
24.27 score on a scale
Standard Deviation 3.47

Adverse Events

Traditional Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Pedagogical Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ms. Mishal Liaqat (Principal Investigator)

Lahore school of nursing, University of lahore, Pakistan

Phone: +923441481666

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place