Comparing the effects of two methods of smartphone-based software and role-playing for teaching neonatal resuscitation program on self-efficacy, knowledge and clinical skills of undergraduate nursing students
Impact of Smartphone Software and Role-Playing on Self-Efficacy, Knowledge, and Clinical Skills in Neonatal Resuscitation Among Undergraduate Nursing Students at Shiraz University of Medical Sciences. in 2025-2026
Design
A cluster randomized trial with a control group and two intervention groups, double-blind, phase 3 on 112 undergraduate nursing students.
Settings and conduct
The research will be conducted at the Faculty of Nursing and Midwifery of Hazrat Fatemeh in Shiraz. During the second semester of the 2024-2025 academic year and the first semester of the 2025-2026 academic year, the researcher will visit classes of 7th and 8th-semester nursing students. Written informed consent will be obtained from students who are interested in participating after the research purpose is explained.
Participants/Inclusion and exclusion criteria
1. Having an Android phone
2. Willingness to participate in the study
Intervention groups
Smartphone-based software intervention group: For the smartphone-based software test group, the neonatal resuscitation program training will be installed on Android.
Role-playing intervention group: the students in the role-playing intervention group will be presented with a resuscitation scenario.
Control Group: students in the control group will only receive the standard neonatal resuscitation program training in the form of lectures using PowerPoint and video presentations.
Main outcome variables
Self-efficacy, clinical knowledge and skills
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250421065433N1
Registration date:2025-05-13, 1404/02/23
Registration timing:prospective
Last update:2025-05-13, 1404/02/23
Update count:0
Registration date
2025-05-13, 1404/02/23
Registrant information
Name
fateme eshghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 846 7420
Email address
fatemeeshghi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2026-03-06, 1404/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of two methods of smartphone-based software and role-playing for teaching neonatal resuscitation program on self-efficacy, knowledge and clinical skills of undergraduate nursing students
Public title
The effect of two methods: smartphone-based software and role-playing for teaching neonatal resuscitation program on self-efficacy, knowledge, and clinical skills of undergraduate nursing students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having an Android phone
Willingness to participate in the study
Exclusion criteria:
Participate in another neonatal resuscitation program educational study during the duration of this research.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible samples will be placed into intervention and control groups using cluster randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants, as well as data collectors and data analysts, will be kept blind to the study groups.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Opposite Palestine Street, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2025-02-05, 1403/11/17
Ethics committee reference number
IR.SUMS.REC.1403.483
Health conditions studied
1
Description of health condition studied
Undergraduate Nursing Students
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-efficacy score
Timepoint
Before the intervention, after the intervention and one month later
Method of measurement
The Resuscitation Self-efficacy Scale will be used.
2
Description
Knowledge score
Timepoint
Before the intervention, after the intervention and one month later
Method of measurement
It will consist of 30 multiple choice questions (MCQs) based on the steps of the neonatal resuscitation program that will assess knowledge of neonatal resuscitation.
3
Description
Clinical skill score
Timepoint
Before the intervention, after the intervention and one month later
Method of measurement
The OSCE Neonatal Resuscitation Checklist and Neonatal Resuscitation Scenario will be used to assess clinical skills.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Smartphone-based software for the test group Smartphone-based software, training in the neonatal resuscitation program under Android, will be installed. This software will be available to the test group for one month and will be locked after one month. The educational software will be installed on the students' phones in a one-hour session and they will be trained on how to use it. Web programmer engineers and graphic designers will be used to design the background and icons to prepare the educational software. The content of the educational program will be created based on the 2021 American Heart Association guidelines, which will consist of 4 main sections: introducing the software, listing, introducing educational resources, and exiting the program. In order to prevent information contamination and the lack of access to the software by the role-playing and control intervention groups and other students until the end of the study, it will be foreseen for the software password that each virtual user who has a defined password for himself can use to log in and install the software. A management software will also be used to track the number of times the software is logged in, which will display the usage of each user. For the scientific validity of the software, the opinions of 3 faculty members who are experts in the fields of neonatal intensive care, neonatal resuscitation program, and smartphone-based software design will be used. After collecting expert opinions, the necessary corrections will be made.
Category
Other
2
Description
Intervention Group Role-Playing Intervention: After receiving the usual training using PowerPoint and film, the students in the role-playing intervention group will be presented with a resuscitation scenario. Based on the scenario, each student will be assigned a specific role in the resuscitation team, such as team leader, massage therapist, airway management, or medication administration. The students will then form groups of four and, under the supervision of a project partner (with a master's degree in neonatology and 12 years of experience in working and teaching in the field of neonatology), will actively participate in performing a real resuscitation scene and apply their knowledge and skills in a simulated real world.
Category
Other
3
Description
Control group: Students in the control group will only receive the standard neonatal resuscitation program training, which is delivered through lectures using PowerPoint and video presentations.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Fatemeh School of Nursing and Midwifery, Shiraz
Full name of responsible person
Fateme Eshghi
Street address
Entrance to Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4254
Email
eshghifateme@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr-Hamid Mohammadi
Street address
Opposite Palestine Street, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
mohammadi@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Eshghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Entrance to Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4254
Email
eshghifateme@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Eshghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Entrance to Namazi Hospital, Namazi Square,Shiraz,
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4254
Email
eshghifateme@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Eshghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Entrance to Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4254
Email
eshghifateme@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The protocol and scientific articles resulting from the research will be published in reputable journals.
When the data will become available and for how long
After publication
To whom data/document is available
All people interested in this field
Under which criteria data/document could be used
It can be used if intellectual property is preserved.
From where data/document is obtainable
Publisher's magazine website
What processes are involved for a request to access data/document