Protocol summary

Study aim
Determining and comparing the effect of an educational intervention based on the Sexual Health Model using the serious game 'Consultant Monopoly' on the knowledge, reasoning skills, and attitudes of nursing and midwifery students regarding the Human Papillomavirus.
Design
The sample size is 96 participants, accounting for attrition. To control for confounders, stratified randomization will assign participants to two groups. The allocation process involves two stages: Random sequence generation: Using Random Allocation software. Allocation concealment: A trained individual, independent from intervention implementation and data analysis, will implement the sequence to keep interventions concealed until formal group assignment. Blinding of participants and intervention providers is not feasible due to the nature of the interventions.
Settings and conduct
This study is a randomized controlled trial with a pretest-posttest-follow-up design. The setting of this study is the Nursing and Midwifery School at Shahid Sadoughi University of Medical Sciences in Yazd
Participants/Inclusion and exclusion criteria
Inclusion Criteria : Nursing and midwifery students from the third semester onwards at Shahid Sadoughi University of Medical Sciences in Yazd. Willingness to participate and provision of informed consent. Exclusion Criteria : Unwillingness to continue participation in the study.
Intervention groups
The Sexual Health Model-based group will receive three in-person, 2-hour group sessions. The serious game group will play "Consultant Monopoly" in person, in groups of six. For both groups, the educational content is designed based on the Sexual Health Model, focusing on HPV-related knowledge, attitudes, and reasoning skills.
Main outcome variables
knowledge، reasoning skills، attitudes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260104068539N1
Registration date: 2026-05-01, 1405/02/11
Registration timing: retrospective

Last update: 2026-05-01, 1405/02/11
Update count: 0
Registration date
2026-05-01, 1405/02/11
Registrant information
Name
zahra Rastegarqhavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1752
Email address
z.rastegarqhavi@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-02-15, 1404/11/26
Expected recruitment end date
2026-03-17, 1404/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Sexual Health Model-Based Education and the Serious Game 'Counselor Monopoly' on Knowledge, Reasoning Skills, and Attitudes of Nursing and Midwifery Students about the Human Papillomavirus
Public title
Comparison of the Effect of Sexual Health Model-Based Education and the Serious Game 'Counselor Monopoly' on Knowledge, Reasoning Skills, and Attitudes of Nursing and Midwifery Students about the Human Papillomavirus
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Nursing and midwifery students from the third semester at Shahid Sadoughi University of Medical Sciences in Yazd Willingness and having informed consent to participate in the study
Exclusion criteria:
Age
From 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were allocated to the two intervention groups using a stratified randomization method based on field of study (nursing/midwifery) and academic semester. Accordingly, participants were first categorized into homogeneous strata according to the aforementioned variables, and then within each stratum, group allocation was performed randomly using Random Allocation software. To ensure allocation concealment, the allocation sequence was generated and maintained by a trained individual who was independent of both the intervention implementation and data analysis teams, and it remained concealed until participants were assigned to the groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Bu Ali Alley, Timsar Fallahi Street
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۱۸۴۱۱
Approval date
2025-11-05, 1404/08/14
Ethics committee reference number
IR.SSU.REC.1404.116

Health conditions studied

1

Description of health condition studied
Human Papillomavirus
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Knowledge was assessed using a questionnaire.
Timepoint
before the intervention , immediately after the intervention , and 4 and 12 weeks post-intervention
Method of measurement
The Knowledge and Attitude Questionnaire regarding Human Papillomavirus

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The educational intervention in this group will be delivered through a designed educational game titled "Consultant Monopoly." This game was developed by adapting and localizing the game Polmonopoly (or Monopoly) and is tailored to the curriculum of the Sexual Health Model-based intervention. Initially, participants will attend an orientation session to become familiar with the game mechanics and its objectives. Subsequently, after screening, they will be randomly divided into eight groups of six using simple randomization while adhering to the principle of homogenization. The results of the group allocation will then be communicated to them.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nursing and Midwifery School, Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Mahshid bokaie
Street address
Bu Ali Alley, Timsar Fallahi Street
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۱۸۴۱۱
Phone
+98 35 3824 1752
Email
zahrarastegar034@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
معاون تحقیقات و فناوری
Street address
Bu Ali Alley, Timsar Fallahi Street
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۱۸۴۱۱
Phone
+98 913 770 9693
Email
zahrarastegar034@gmail.com
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
مهشید بکایی
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Bu Ali Alley, Timsar Fallahi Street
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۱۸۴۱۱
Phone
+98 35 3824 1751
Email
mah_bokaie@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahshid bokaie
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Bu Ali Alley, Timsar Fallahi Street
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۱۸۴۱۱
Phone
+98 35 3824 1751
Email
mah_bokaie@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra rastegarghavi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Chamran Alley, Salman Street, Maskan Square
City
Yazd
Province
Yazd
Postal code
8915747861
Phone
+98 913 770 9693
Email
z.rastegarqhavi@stu.ssu.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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