NCT04748341

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 10, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2021

Completed
2 months until next milestone

Results Posted

Study results publicly available

May 18, 2021

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

1 month

First QC Date

February 3, 2021

Results QC Date

March 26, 2021

Last Update Submit

May 17, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    before intervention and 6 weeks after intervention

Study Arms (2)

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.

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.

Other: Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain)

Interventions

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.

Pedagogical Group

The traditional method group learns through 2-step method. 1. didactic lectures on neonatal resuscitation were delivered. 2. Practice skill on mannequins

Traditional Group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Will be on leave from that period
  • Have already received any educational training on neonatal resuscitation.
  • Working as Nursing Assistants in Clinical Setting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Nursing, Allama Iqbal Medical College.

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Educational StatusVision, OcularBenzocaine

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsLight Signal TransductionSignal TransductionBiochemical PhenomenaChemical PhenomenaCell Physiological PhenomenaSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaOcular Physiological Phenomenapara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Ms. Mishal Liaqat (Principal Investigator)
Organization
Lahore school of nursing, University of lahore, Pakistan

Study Officials

  • Mishal Liaqat

    Lahore School of Nursing, The University of Lahore

    PRINCIPAL INVESTIGATOR
  • Muhammad Hussain

    Lahore School of Nursing, The University of Lahore

    STUDY CHAIR
  • Muhammad Afzal

    Lahore School of Nursing, The University of Lahore

    STUDY CHAIR
  • Amir Gillani

    Faculty of Allied Health Sciences, The University of Lahore

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The data will be collected at two points in time. 1st-time data will be collected as a pre-test before the educational intervention. The 2nd-time data will be collected after 6 weeks of educational intervention. Two facilitator evaluators will be trained regarding the scoring of each scale in a two-hour workshop before data collection. All the students were allotted code after allocation. Only the principal investigator knows the allocation status of each student code. The skill was tested through simulation scenarios in the skill lab. The facilitators, who assessed the student's skills, endure uninformed regarding the student's allocation status and sequence of the scenario in the pre-and post-data collection.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 10, 2021

Study Start

February 10, 2021

Primary Completion

March 22, 2021

Study Completion

March 25, 2021

Last Updated

May 18, 2021

Results First Posted

May 18, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations