Protocol summary

Study aim
Determining the effect of a Mobile application based on the protection motivation theory on the preventive behaviors of harmful effects of sunshine in girl and boy students
Design
Clinical trial with control group, with parallel groups, Not blinded , randomized, phase zero on 320 male and female students
Settings and conduct
The place of study in Zahedan and how to implement it by installing an educational application on a mobile phone
Participants/Inclusion and exclusion criteria
Male and female students in the fourth to sixth grades of elementary school in Zahedan in the year 1399-1400
Intervention groups
. We will provide a 3D mobile application for aging the face that allows the user (target group students) to take a 3D selfie and then offers the person two categories of classification 1. Daily protection Sun exposure 2- Lack of daily protection from the sun and then the changed face of a person during the next 5 to 25 years when exposed to prolonged and frequent exposure to ultraviolet light of the sun. All effects by type. The skin is the person that the user can choose at the beginning of the program. The app also shows the most common skin cancers caused by ultraviolet light through additional buttons and calculates how the odds ratio increases with different behaviors. In addition, the program advises on sun protection, explains facial changes, and examines the skin using ABCDE (asymmetry), border irregularity, color variation. encourages variety, diameter, and evolution. The control group is a group that does not intervene in order to satisfy the maximum internal validity. But at the end of the study and after collecting the data, we do the same intervention that we did in the intervention group in the control group.
Main outcome variables
The effact of education on the behavior and structures of protection motivation theory

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200924048825N1
Registration date: 2021-02-08, 1399/11/20
Registration timing: prospective

Last update: 2021-02-08, 1399/11/20
Update count: 0
Registration date
2021-02-08, 1399/11/20
Registrant information
Name
ESMAT-TOSADAT HOSSEINI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 0098
Email address
e.hosseini@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
design and evaluation of a Mobile application based on the protection motivation theory on the preventive behaviors of harmful effects of sunshine in girl and boy students
Public title
The effect of education Mobile application on the preventive behaviors of harmful effects of sunshine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female students in the fourth to sixth grades of elementary school in Zahedan in the year 1399-1400
Exclusion criteria:
Reluctance and satisfaction to participate in the study Absence of students
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 320
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Limited randomization because we want the sample size to be equal in both intervention and control groups, so we will choose this limited randomization as a block randomization with 5 blocks and in each block one school in the intervention group and one school in the group Control is placed. Randomization unit: Multi-stage cluster Randomization tool: statistical software Random allocation concealment: using opaque envelopes sealed with random sequence In this way, based on the volume of the research sample, a number of envelopes with aluminum wrappers (in order not to clarify the contents of the envelopes) are prepared and each of the random assignments created is recorded on a card And the cards are placed in the mail envelopes in order . In order to maintain a random sequence, envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside the boxes, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants to study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.
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
دانشگاه علوم پزشکی شهید صدوقی یزد
Street address
Sarollah Boulevard 7
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817765377
Approval date
2020-10-21, 1399/07/30
Ethics committee reference number
IR.SSU.SPH.REC.1399.135

Health conditions studied

1

Description of health condition studied
skin cancer
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
knowledge and behavior and structures of protection motivation
Timepoint
pretest and postest
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention in the school under evaluation, which includes a educational session of approximately 25 to 30 minutes, including the installation and download time of 45 minutes, will be performed in the virtual classroom environment of Shad software using a photography application. For the first 10 minutes, the student takes a three-dimensional selfie, then offers two categories of classification. . In 15 to 20 minutes, the student interacts with the remaining functions of the program, including facial changes, ABCDE rules, and sun protection instructions. In the last 5 to 10 minutes. After the intervention, the participants are sent instructions to remove the application from their phone and immediately after the intervention, students are asked to assess the understanding of the intervention immediately after the intervention. Complete (postest) and send to the executor. Again, 3 and 6 months after the intervention, an invitation will be sent to the students' knowledge, who will be asked to receive a post-test questionnaire and send it to the project manager after completion.
Category
Prevention

2

Description
Control group: There is no intervention and at the end of the work, educational materials will be provided to them.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
مدارس ابتدایی دخترانه و پسرانه شهر زاهدان
Full name of responsible person
عصمت السادات حسینی
Street address
Boulevard saralah 7
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817765377
Phone
+98 54 3344 0098
Email
hosini.esmat@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
esmat sadat hosseini
Street address
Yazd-Alam Square Boulevard shohaday gomnam
City
yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Phone
+98 35 3820 9100
Email
hosini.esmat@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
esmat sadat hosseini
Position
student phd
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
bolvare saralah 7
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817765377
Phone
+98 54 3344 0098
Fax
Email
hosini.esmat@gmail .com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
esmat sadat hosseini
Position
student phd
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
bolvare saralah 7
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817765377
Phone
+98 54 3344 0098
Email
e.hosseini@stu.ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
esmat sadat hosseini
Position
student phd
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
bolvare saralah 7
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817765377
Phone
+98 54 3344 0098
Email
hosini.esmat@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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