Design, Development, and Evaluation of the Impact of a Smartphone-Based Self-Management Application on Pubertal Health in Adolescent Boys in Urmia in 2025
Design
A total of 90 adolescent boys in Urmia will be divided into control and intervention groups. In the first group, 45 individuals will be purposefully and conveniently selected and subjected to pre-test and post-test assessments. In the second group, 45 adolescent boys from Urmia will be assessed randomly.
Sampling will be conducted using a multistage cluster sampling method. From the two education districts of Urmia (Districts 1 and 2), one area of public schools with different levels of resources (high-resource, medium-resource, low-resource) will be selected in each district. One school from each area will then be randomly chosen. In total, two schools will be randomly selected for the intervention group and two schools for the control group.
Settings and conduct
Public lower secondary schools for boys
Participants/Inclusion and exclusion criteria
Adolescent boys with pubertal experience, selected from selected schools in Urmia, and willing to use the application for self-management of pubertal health
Intervention groups
Adolescents in the intervention group will use the designed application for 10 to 15 minutes daily for 4 weeks. The control group will receive no intervention
Main outcome variables
Awareness of pubertal changes; self-confidence; sexual orientation; mood swings; health-related behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250905067127N1
Registration date:2025-10-12, 1404/07/20
Registration timing:prospective
Last update:2025-10-12, 1404/07/20
Update count:0
Registration date
2025-10-12, 1404/07/20
Registrant information
Name
Milad Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3384 5525
Email address
miladbardiagh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-21, 1404/11/01
Expected recruitment end date
2026-08-22, 1405/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of a self-management application based on a smartphone on pubertal health in Adolescent Boys
Public title
Examining the effect of a smartphone-based self-management application on pubertal health in adolescent boys
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Teenage boys from public schools and experiencing puberty
Boys willing to use app for self-management of pubertal health
Exclusion criteria:
Age
From 10 years old to 15 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done using a multi-stage cluster sampling method, which will select one area of public schools with different levels of access (advantaged, semi-advantaged, under-advantaged) from two education districts of Urmia (districts 1 and 2). In each district, one school will be randomly selected. In total, 2 schools will be randomly selected for the intervention group and 2 schools for the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Urmia University of Medical Sciences
Street address
No. 14, Shekarchi Ave.
City
Urmia
Province
West Azarbaijan
Postal code
5716758537
Approval date
2025-08-27, 1404/06/05
Ethics committee reference number
IR.UMSU.REC.1404.178
Health conditions studied
1
Description of health condition studied
pubertal health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pubertal health
Timepoint
Assessment of pubertal health at baseline and six months after using the self-management application.
Method of measurement
The Adolescent Boys’ Pubertal Health Needs Questionnaire developed by Yao et al.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving education through the smartphone-based self-management application for a duration of six months
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
مدارس دولتی دوره اول متوسطه پسران
Full name of responsible person
Milad Ghasemi
Street address
Imam Khomeini Hospital, Ershad Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715789399
Phone
+98 914 282 8947
Email
miladbardiagh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
صابر قلی زاده
Street address
Jihad Street, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 1930
Email
research@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research and Technology Deputy
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
Oroumia University of Medical Sciences
Full name of responsible person
Milad Ghasemi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
N28,shekarchi st. Urmia, West Azarbijan
City
Urmia
Province
West Azarbaijan
Postal code
5716758537
Phone
+98 44 3384 5525
Fax
Email
miladbardiagh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Milad Ghasemi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 14, Shekarchi Ave.
City
Urmia
Province
West Azarbaijan
Postal code
5716758537
Phone
+98 44 3223 1930
Email
miladbardigh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Milad Ghasemi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
N28,shekarchi st. Urmia, West Azarbijan
City
Urmia
Province
West Azarbaijan
Postal code
5716758537
Phone
+98 44 3384 5525
Fax
Email
miladbardiagh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No further information is 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
No - There is not a plan to make this available
Clinical Study Report
Not applicable
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