NCT04623411

Brief Summary

Neonatal death is one of the important indicators showing the development level of countries. Many newborn deaths are preventable. Preventable neonatal deaths arise from events such as birth asphyxia at the time of delivery. Nursing students receive neonatal resuscitation training with classical training methods and graduate without the opportunity to experience it in a clinical setting. The aim of the study is to evaluate the effectiveness of web-based serious game simulation method in neonatal resuscitation training given to nursing students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2021

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

November 4, 2020

Last Update Submit

July 19, 2021

Conditions

Keywords

Newborn ResuscitationSimulationSerious gameNursing Student

Outcome Measures

Primary Outcomes (2)

  • Neonatal resuscitation knowledge level assessment questionnaire

    This 15-item multiple-choice questionnaire was developed by the researchers to evaluate the knowledge level of the participants. Each question will be evaluated as correct answer = 1 point, wrong answer = 0 points. Participants will fill in online before and after the training.

    Immediately before training and one week after training completion

  • Evaluation of Newborn Resuscitation Practice Skills

    Serious game simulation software will be used to Assess Newborn Resuscitation Practice Skill. Participants will be expected to practice web-based neonatal resuscitation with serious game simulation and their skills will be evaluated. Each correct practice will be evaluated as sufficient 1 point and incorrect practice will be evaluated as 0 points.

    Immediately before training and one week after training completion

Secondary Outcomes (1)

  • Student Satisfaction and Self-Confidence in Learning Scale

    One week after training completion

Study Arms (2)

Intervention Group

EXPERIMENTAL

Neonatal resuscitation training with classical method and serious game simulation method

Behavioral: Neonatal resuscitation training with classical method and serious game simulation method

Control Group

EXPERIMENTAL

Neonatal resuscitation training with classical method.

Behavioral: Control Group

Interventions

After the theoretical training, the participants will be given technical information on the use of web-based neonatal resuscitation serious game simulation method. Each participant will be asked to apply this method at least three times.

Intervention Group
Control GroupBEHAVIORAL

Neonatal resuscitation training with classical method

Control Group

Eligibility Criteria

Age18 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Students who are volunteers, Those who attend the Neonatal Nursing Course, Nursing students in the 3rd grade, Students with laptops

You may not qualify if:

  • Those with neonatal resuscitation certificate, Students without internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Konyaaltı, Turkey (Türkiye)

Location

Related Publications (2)

  • Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.

    PMID: 26473001BACKGROUND
  • Ghoman SK, Cutumisu M, Schmolzer GM. Simulation-Based Summative Assessment of Neonatal Resuscitation Providers Using the RETAIN Serious Board Game-A Pilot Study. Front Pediatr. 2020 Jan 31;8:14. doi: 10.3389/fped.2020.00014. eCollection 2020.

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The control and intervention group will be formed by randomization. The intervention and control group will be defined as group 1 and group 2 for statistical analysis. Data analysis will be evaluated and reported by the statistician. Also the statistician will be blind.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This was pretest-posttest design, randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 10, 2020

Study Start

October 1, 2020

Primary Completion

November 29, 2020

Study Completion

March 9, 2021

Last Updated

July 23, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations