Nursing Students Education on Neonatal ResuscitationNCT04748341
The Impact of Pedagogical Framework in Education of Neonatal Resuscitation
A study testing Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain) and Traditional Method in people with Nursing Students Education on Neonatal Resuscitation, run by University of Lahore at 1 site in Pakistan.
Trial summary
Virtually 10% of newborns suffer respiratory distress at birth thus need intervention from proficient health professionals. Pakistan is one of the top ten countries that carry two-thirds of the global burden of neonatal deaths. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nursing Students Education on Neonatal Resuscitation
- What is being tested?
- Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain) and Traditional Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Feb 2021to 25 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are currently enrolled in the Bachelor of Science in Nursing (4 years) 3rd and 4th Professional.
- Those willing to attend the full course of neonatal resuscitation.
- Having age 18-25 years.
- Those willing to give informed consent.
Who cannot join
- Will be on leave from that period
- Have already received any educational training on neonatal resuscitation.
- Working as Nursing Assistants in Clinical Setting.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
College of Nursing, Allama Iqbal Medical College.
Lahore, Punjab Province, 54000
About this study
Official title: The Efficacy of Pedagogical Framework (Learn, See, Practice, Prove, Do, Maintain) on Knowledge, Skill, and Self-Efficacy of Nursing Students Regarding Neonatal Resuscitation.
Virtually 10% of newborns suffer respiratory distress at birth thus need intervention from proficient health professionals. Pakistan is one of the top ten countries that carry two-thirds of the global burden of neonatal deaths. It is suggested that most of these deaths can be prevented through the provision of trained emergency birth attendants, in which education plays an integral role. Since its inception in the neonatal resuscitation program, we are still in the struggle to find out the best strategies to disseminate NRP knowledge, training, and guidelines that promise the best outcome. Hence, little published data on this phenomenon is available regarding undergraduate students. That determines the best way to educate them in performing the skills that urgently require an infrequent needed such as neonatal resuscitation. Therefore, this study intended to address this gap in the education of neonatal resuscitation through two different approaches. One is a traditional 2-step method and the other is an adapted Pedagogical framework (Lean, See, Practice, Prove, Do and Maintain).
Read the detailed description
Globally, nurses are the largest workforce in the healthcare system that are directly engaged in the provision of newborn care. They should be conversant and competent in neonatal resuscitation. However, the majority of nurses are not skillful in the respective field. The situation is not very different when we are talking about nursing students. Who are our future workforce, hence are found incompetent in emergency newborn management and neonatal resuscitation. It is well documented that effective educational programs in preservice settings such as schools of midwifery, nursing, and medicine, established more active forms of lifelong learning to improve the quality of care. While the transformation of theoretical knowledge into clinical practice requires effective teaching in the field of resuscitation is a vital element for all undergraduate students. However, like many other developing countries in Pakistan, mostly traditional methods are following in nursing education. While the traditional method of teaching is insufficient to meet the educational demands of nursing students in clinical practice. Hence, Nursing students often are unprepared and lacking confidence in simple, yet life-saving procedures such as neonatal resuscitation. Therefore, incorporating an effective model and framework in nursing education is needed that could enhance nursing students' skills and improve clinical outcomes. The "Learn, See, Practice, Prove, Do, and Maintain" (LSPPDM) pedagogy is one of such frameworks synthesized after intensely reviewing the literature. This framework is acting as a guiding path for educators in teaching and learning procedural skills. As Knowledge is considering a prerequisite for competence in skill performance and to evaluate the effectiveness of an educational program self -efficacy measurement is an important tool. Thus, the important variables knowledge, self-efficacy, and skill have been selected for this study. Thus, the study objective will be:
To compare the knowledge, skill, and self-efficacy among undergraduate nursing students learning of neonatal resuscitation through "Learn, See, Practice, Prove, Do, Maintain pedagogy" as compared to those who will learn through the traditional method.
This study will contribute essentially to determine the effectiveness of an adapted pedagogical framework in the teaching and learning of neonatal resuscitation skills, especially in a resource-limited society. Moreover, the study findings will help the organization to develop strategies for improving nursing education.
- Being tested
- Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain), Traditional Method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain)Other
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.
Traditional MethodOther
The traditional method group learns through 2-step method.
- didactic lectures on neonatal resuscitation were delivered.
- Practice skill on mannequins
| Study group | Role | What they receive |
|---|---|---|
| Traditional Group | Active comparator | 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. Receives: Other: Traditional Method |
| Pedagogical Group | Experimental | 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. Receives: Other: Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Questionnaire
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.
Measured: before intervention and 6 weeks after intervention
Self-efficacy for Neonatal Resuscitation (SENR)
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.
Measured: before intervention and 6 weeks after intervention
Neonatal Resuscitation Checklist
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.
Measured: before intervention and 6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start10 Feb 2021
- Primary completion22 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nursing Students Education on Neonatal ResuscitationStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a Single-blind randomized control trial conducted in the College of Nursing, Allama Iqbal Medical College, Lahore, Pakistan. A sample size of 72 nursing students (36 in each group) will be taken through simple random sampling. The students allocated from each professional in group A and group B through the Lottery method. Allocation of participants was concealed using envelop method. A total of 6 weeks of intervention will be provided to both groups. Group A will be taught through the two steps traditional method (2 lectures/week + 1 skill lab/week). On the contrary Group B will learn through the 6-step method constituted 2 lecture/week + video + 2skill lab/week (1 session under instructor + 1 session for skill maintenance).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mishal Liaqat, University of Lahore
- Investigators
- Mishal Liaqat, Principal investigator, Lahore School of Nursing, The University of LahoreMuhammad Hussain, Study chair, Lahore School of Nursing, The University of LahoreMuhammad Afzal, Study chair, Lahore School of Nursing, The University of LahoreAmir Gillani, Study director, Faculty of Allied Health Sciences, The University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748341
- Sponsor's protocol ID
- IRB-UOL-FAHS/775/2020
- Status last verified
- May 2021
- First submitted
- 3 Feb 2021
- Last updated
- 18 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liaqat M, Hussain M, Afzal M, Altaf M, Khan S, Gilani SA, Liaqat I. Efficacy of pedagogical framework in neonatal resuscitation skill learning in a resource-limited setting: a randomized controlled trial. BMC Med Educ. 2021 Aug 18;21(1):436. doi: 10.1186/s12909-021-02846-x.
PubMed 34407810
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Pedagogical Framework (Learn, See, Practice, Prove, Do, Maintain) on Knowledge, Skill, and Self-Efficacy of Nursing Students Regarding Neonatal Resuscitation.
- ClinicalTrials.gov ID
- NCT04748341
- Acronym / sponsor ID
- IRB-UOL-FAHS/775/2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Posted 18 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Virtually 10% of newborns suffer respiratory distress at birth thus need intervention from proficient health professionals. Pakistan is one of the top ten countries that carry two-thirds of the global burden of neonatal deaths. It is suggested that most of these deaths can be prevented through the provision of trained emergency birth attendants, in which education plays an integral role. Since its inception in the neonatal resuscitation program, we are still in the struggle to find out the best strategies to disseminate NRP knowledge, training, and guidelines that promise the best outcome. Hence, little published data on this phenomenon is available regarding undergraduate students. That determines the best way to educate them in performing the skills that urgently require an infrequent needed such as neonatal resuscitation. Therefore, this study intended to address this gap in the education of neonatal resuscitation through two different approaches. One is a traditional 2-step method and the other is an adapted Pedagogical framework (Lean, See, Practice, Prove, Do and Maintain).
Detailed description
Globally, nurses are the largest workforce in the healthcare system that are directly engaged in the provision of newborn care. They should be conversant and competent in neonatal resuscitation. However, the majority of nurses are not skillful in the respective field. The situation is not very different when we are talking about nursing students. Who are our future workforce, hence are found incompetent in emergency newborn management and neonatal resuscitation. It is well documented that effective educational programs in preservice settings such as schools of midwifery, nursing, and medicine, established more active forms of lifelong learning to improve the quality of care. While the transformation of theoretical knowledge into clinical practice requires effective teaching in the field of resuscitation is a vital element for all undergraduate students. However, like many other developing countries in Pakistan, mostly traditional methods are following in nursing education. While the traditional method of teaching is insufficient to meet the educational demands of nursing students in clinical practice. Hence, Nursing students often are unprepared and lacking confidence in simple, yet life-saving procedures such as neonatal resuscitation. Therefore, incorporating an effective model and framework in nursing education is needed that could enhance nursing students' skills and improve clinical outcomes. The "Learn, See, Practice, Prove, Do, and Maintain" (LSPPDM) pedagogy is one of such frameworks synthesized after intensely reviewing the literature. This framework is acting as a guiding path for educators in teaching and learning procedural skills. As Knowledge is considering a prerequisite for competence in skill performance and to evaluate the effectiveness of an educational program self -efficacy measurement is an important tool. Thus, the important variables knowledge, self-efficacy, and skill have been selected for this study. Thus, the study objective will be:
To compare the knowledge, skill, and self-efficacy among undergraduate nursing students learning of neonatal resuscitation through "Learn, See, Practice, Prove, Do, Maintain pedagogy" as compared to those who will learn through the traditional method.
This study will contribute essentially to determine the effectiveness of an adapted pedagogical framework in the teaching and learning of neonatal resuscitation skills, especially in a resource-limited society. Moreover, the study findings will help the organization to develop strategies for improving nursing education.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study design is a Single-blind randomized control trial conducted in the College of Nursing, Allama Iqbal Medical College, Lahore, Pakistan. A sample size of 72 nursing students (36 in each group) will be taken through simple random sampling. The students allocated from each professional in group A and group B through the Lottery method. Allocation of participants was concealed using envelop method. A total of 6 weeks of intervention will be provided to both groups. Group A will be taught through the two steps traditional method (2 lectures/week + 1 skill lab/week). On the contrary Group B will learn through the 6-step method constituted 2 lecture/week + video + 2skill lab/week (1 session under instructor + 1 session for skill maintenance).
| Arm | Type | Receives |
|---|---|---|
| Traditional Group | Active comparator | Other: Traditional MethodGroup 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. |
| Pedagogical Group | Experimental | Other: Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain)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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Are currently enrolled in the Bachelor of Science in Nursing (4 years) 3rd and 4th Professional.
- Those willing to attend the full course of neonatal resuscitation.
- Having age 18-25 years.
- Those willing to give informed consent.
Key exclusion criteria (3 listed)
- Will be on leave from that period
- Have already received any educational training on neonatal resuscitation.
- Working as Nursing Assistants in Clinical Setting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Pedagogical Group |
| Traditional MethodThe traditional method group learns through 2-step method. 1. didactic lectures on neonatal resuscitation were delivered. 2. Practice skill on mannequins | Other | Traditional Group |
Primary outcome
Knowledge Questionnaire
Time frame: before intervention and 6 weeks after 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.
Self-efficacy for Neonatal Resuscitation (SENR)
Time frame: before intervention and 6 weeks after 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.
Neonatal Resuscitation Checklist
Time frame: before intervention and 6 weeks after 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34407810Liaqat M, Hussain M, Afzal M, Altaf M, Khan S, Gilani SA, Liaqat I. Efficacy of pedagogical framework in neonatal resuscitation skill learning in a resource-limited setting: a randomized controlled trial. BMC Med Educ. 2021 Aug 18;21(1):436. doi: 10.1186/s12909-021-02846-x.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mishal Liaqat principal investigator
Lahore School of Nursing, The University of Lahore
Muhammad Hussain study chair
Lahore School of Nursing, The University of Lahore
Muhammad Afzal study chair
Lahore School of Nursing, The University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain) and Traditional Method in people with Nursing Students Education on Neonatal Resuscitation, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge Questionnaire (time frame: before intervention and 6 weeks after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04748341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.