Determining the effect of simulation with analog game on nursing students' knowledge and skills in teaching elderly people with diabetes.
Determining the effect of simulation with analog game on academic engagement and satisfaction of nursing students with the training course.
Design
Randomized controlled parallel study, on 80 patients
Settings and conduct
Shahid Sadoughi Nursing and Midwifery School, Yazd. Stages of implementation: First stage: data collection in the pre-test stage, second stage: implementation of the intervention, and third stage: data collection in the post-test after one month.
Participants/Inclusion and exclusion criteria
Willingness to participate in the study
Take theoretical courses and internships in adult health nursing (internal surgery) 1 to 3, patient education courses and take adult health nursing courses 4 and home care nursing and individual, family, environmental and community health nursing courses
Students who are on leave or sick leave
Intervention groups
The samples are randomly assigned to two intervention and control groups using cluster randomization (groups of 4) using random assignment software. The intervention in the intervention group is implemented in two stages. The first stage is communication and education sessions for elderly people with type 2 diabetes for students. The second stage is a simulation of education for elderly people with diabetes, along with an analog game. Students participate in these educational games in groups of 4. In the control group, students will participate in the educational sessions of the first stage.
Main outcome variables
Knowledge and skill variable
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250623066225N1
Registration date:2025-07-16, 1404/04/25
Registration timing:prospective
Last update:2025-07-16, 1404/04/25
Update count:0
Registration date
2025-07-16, 1404/04/25
Registrant information
Name
Elham Eshaghi Gorji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 907 0846
Email address
e.eshaghigorji@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2026-05-21, 1405/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Simulation with Analog Game on the Knowledge and Skills of Nursing Students in Teaching the Elderly with Diabetes
Public title
Impact of Analog Simulation Game on Nursing Students' Diabetes Education for Older Adults
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Passing theoretical courses and internships in adult health nursing (internal surgery) 1 to 3, patient education courses and taking adult health nursing courses 4 and home care nursing and individual, family, environmental and community health nursing courses
Exclusion criteria:
Students who are on leave or sick leave
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method: Cluster randomization
Unit of Randomization: Cluster-based, with approximately 4-student clinical/workshop groups formed based on students’ preferences and natural grouping during the semester
Stratification: Not applied
Randomization Tool: Online tool random.org/sequences and sealed, numbered envelopes for concealment
Random Sequence Generation: A list of clinical training groups was created based on the academic schedule. Random allocation sequence was generated using the online tool and placed into individually sealed envelopes labeled by group number
Allocation Concealment: Only the group number was visible on the envelopes. The intervention/control status was concealed until the envelope was opened by the student, who then reported the assigned group to the researcher
Blinding (investigator's opinion)
Single blinded
Blinding description
In this way, the pre-test and post-test evaluators do not know which group (intervention or control) the students are in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Sadoughi University of Medical Sciences
Street address
Imam Reza Complex, Research and Technical Assistant, Imam Hossein Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Approval date
2025-06-15, 1404/03/25
Ethics committee reference number
IR.SSU.REC.1404.034
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
2
Description of health condition studied
Lifestyle and self-care problems in older adults with diabetes
ICD-10 code
Z72.9
ICD-10 code description
Problem related to lifestyle, unspecified
3
Description of health condition studied
Training nurses and nursing students in self-care and monitoring the elderly
ICD-10 code
Z74.3
ICD-10 code description
Need for continuous supervision
4
Description of health condition studied
Knowledge and skills of nursing students in educating and counseling elderly people with type 2 diabetes
ICD-10 code
Z71.8
ICD-10 code description
Other specified counseling
Primary outcomes
1
Description
Knowledge
Timepoint
Pre-test and Post-test
Method of measurement
Measuring the level of knowledge on the topic of self-care education in elderly people with diabetes includes a test containing 23 questions and is researcher-made.
2
Description
Skill
Timepoint
Pre-test and Post-test
Method of measurement
The OSCA assessment checklists and questions for each station include three checklists and three 10-minute stations. The scenario questions and checklists are researcher-created.
Secondary outcomes
1
Description
Satisfaction
Timepoint
After the completion of the educational course
Method of measurement
Satisfaction survey questionnaire
Intervention groups
1
Description
Intervention group: The intervention for the experimental group consists of two main stages. In the first stage, educational sessions on “communication and education for elderly patients with type 2 diabetes” are held for all students in both groups. These sessions are delivered by the second researcher (a student), under the guidance and supervision of academic advisors, and take place in two structured two-hour meetings. The session content follows a pre-designed lesson plan attached to the study protocol. In the second stage, a structured educational simulation is designed and implemented exclusively for the intervention group, incorporating an analog board game. Students participate in this game in groups of four. The game aims to enhance students’ cognitive and attitudinal skills in elderly diabetes care, incorporating elements such as playing cards, coins, and special “client encounter” cards. The game is competitive, with players acting as rivals, and the first player to reach 30 points is declared the winner. The game is supervised by the principal researcher, academic supervisors, and, if needed, trained senior students or instructors. Each card is numbered and includes a point value (top left), a replacement coin type (top right), and a cost (center of the card) based on the number and type of coins. Players must answer questions based on taxonomic levels to earn coins and purchase cards. The correct answers are available to the game supervisor. Once a player reaches 10 points, a client encounter card becomes available. These cards include a written simulation scenario, and the student must perform a role-play teaching session for an elderly patient and their family. Other students assist in the role-play but do not earn points. The performance is evaluated by the supervisor using a structured checklist, with a maximum of 10 points awarded in this phase. There are three types of coins: gold (taxonomy level 3), silver (level 2), and bronze (level 1). Correct answers to questions of each level grant the corresponding coin. To buy a card, students must spend the indicated coins, and the used coins are returned to the pool. Each game round includes four students and one supervisor. Several game sessions may be conducted simultaneously under the supervision of multiple evaluators. Since each question is followed by immediate feedback, the content is reinforced for all group members, supporting collaborative learning. The game continues until one student reaches 30 points and is declared the winner.
Category
N/A
2
Description
Control group: Communication and education sessions for elderly people with type 2 diabetes (similar to the first phase of the intervention group) will be held for students by the second researcher (student) and with the guidance and supervision of the supervisors during two two-hour sessions.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Hossien Tavangar
Street address
Faculty of Nursing and Midwifery, Bu Ali Street, opposite the Infertility Center
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
tavangar11@yahoo.com
Web page address
https://nursing.ssu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amir Houshang Mehrparvar
Street address
Imam Hossein (AS) Square - Beginning of Daneshjoo Boulevard - Imam Reza (AS) Educational and Research Complex - Vice President for Research and Technology, Shahid Sadoughi University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۱۸۸۶۳۷
Phone
+98 35 3733 3726
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Bakhshi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Bu Ali Street, opposite the Infertility Center
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 1751 3824
Email
fateme.bakhshii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Bakhshi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Bu Ali Street, opposite the Infertility Center
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 1751 3824
Email
fateme.bakhshii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Bakhshi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Bu Ali Street, opposite the Infertility Center
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3628 7900
Email
fateme.bakhshii@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
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
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All personal data of study participants can be shared after de-identification. Data sharing is done by uploading to official data sharing databases or by requesting the applicant in the form of an email to the corresponding author.
When the data will become available and for how long
6 months after publication of the article
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
For scientific application and use for systematic review studies
From where data/document is obtainable
Fatemeh Bakhshi, Yazd, Bu Ali St., Safaieh, Shahid Sadoughi Faculty of Nursing and Midwifery, Nursing and Midwifery Care Research Center Postal Code: 8916877443 Contact Phone: 0098 9139684626 Email Address: Fateme.bakhshii@gmail.com f.bakhshi@ssu.ac.ir
What processes are involved for a request to access data/document