- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04623411
Use of Serious Game Simulation on Newborn Resuscitation Education
July 19, 2021 updated by: Sureyya Sarvan, PhD, Akdeniz University
The Effect of Serious Game Simulation on Newborn Resuscitation Education of Nursing Students
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.
Study Overview
Status
Completed
Conditions
Detailed Description
The study was planned as a randomized controlled trial with a single blind, pretest-posttest design.
This study will be conducted in the Fall Semester of the 2020-2021 Academic Year with nursing students studying in the 3rd grade of Akdeniz University Faculty of Nursing between October and December 2020.
An intervention and control group (intervention group: 50, control group: 50) will be formed from 100 students who accepted to participate in the study.
Participants will be randomly allocated to one of the two groups.
Pre-test and post-test will be applied to both groups before and after the training.
Neonatal resuscitation training will be given online to the intervention and control group.
After the theoretical training, web-based neonatal resuscitation serious game simulation will be applied to the intervention group.
Ethics Committee and Institutional Permission was obtained for the study.
In addition, written consent will be obtained from the participants.
Statistical analysis will be done using SPSS 23.0 and significance will be evaluated at p <0.05.
Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz Universit It is predicted that the new information obtained from the data of the research will guide the methods used in education and new researches.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Konyaaltı
-
Antalya, Konyaaltı, Turkey
- Akdeniz University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 23 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Students who are volunteers, Those who attend the Neonatal Nursing Course, Nursing students in the 3rd grade, Students with laptops
Exclusion Criteria:
- Those with neonatal resuscitation certificate, Students without internet access
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Neonatal resuscitation training with classical method and serious game simulation method
|
Behavioral: Neonatal resuscitation training with classical method and serious game simulation method
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. |
|
Experimental: Control Group
Neonatal resuscitation training with classical method.
|
Neonatal resuscitation training with classical method
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neonatal resuscitation knowledge level assessment questionnaire
Time Frame: Immediately before training and one week after training completion
|
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
Time Frame: Immediately before training and one week after training completion
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Student Satisfaction and Self-Confidence in Learning Scale
Time Frame: One week after training completion
|
The scale consists of two sub-dimensions, "satisfaction with learning" and "self-confidence", in five-point Likert type, and a total of 13 items.
There are five items in the satisfaction with learning sub-dimension and eight items in the self-confidence sub-dimension.
Internal consistency coefficient of the scale: 0,90 The internal consistency coefficient of student satisfaction is 0.89, and the self-confidence in learning sub-dimension is 0.83.
|
One week after training completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Actual)
November 29, 2020
Study Completion (Actual)
March 9, 2021
Study Registration Dates
First Submitted
November 4, 2020
First Submitted That Met QC Criteria
November 9, 2020
First Posted (Actual)
November 10, 2020
Study Record Updates
Last Update Posted (Actual)
July 23, 2021
Last Update Submitted That Met QC Criteria
July 19, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 5154
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.