Protocol summary
-
Study aim
-
educational intervention program using mobile application to promote cervical cancer prevention behaviors
-
Design
-
This study is a clinical trial (RCT) with two intervention groups and a control group. Blocked randomization will be used to assign participants to three groups. Envelopes are used to allocate concealment.
-
Settings and conduct
-
According to the inclusion criteria, the target group is women aged 18 to 48 years which will be announced through an internet call on several common social networks for participation in the study.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Women with sexual experience,18-49 years, Resident in Ramsar, Having a smartphone and the ability to use it, no mental disorders, drug dependence and addiction, having a minimum Literacy and the ability to answer questions and discuss in classrooms, lack of midwifery base and related fields of study, having consent to participate in the study.
Exclusion criteria: Mental disorders, drug dependence and addiction, failure to complete the questionnaire, lack of access to the participant for any unpredictable reason.
-
Intervention groups
-
Intervention group 1: The intervention is designed based on the content of the training obtained from the qualitative and review stage of the study using online group discussion teaching methods, photos, videos and etc. will be provided in the mobile application platform.
Intervention group 2: The intervention designed based on the educational content obtained from the qualitative and review stage of the study using the educational content will be received digitally.
-
Main outcome variables
-
Preventive behaviors of cervical cancer prevention behaviors including The intention for doing a screening test (pap-test, genital examination).
General information
-
Reason for update
-
The protocol article is under review in BMC-TRIAL. Correct spelling mistakes
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20181205041861N3
Registration date:
2021-10-26, 1400/08/04
Registration timing:
prospective
Last update:
2022-07-03, 1401/04/12
Update count:
1
-
Registration date
-
2021-10-26, 1400/08/04
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2022-12-22, 1401/10/01
-
Expected recruitment end date
-
2023-03-21, 1402/01/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Design, implementation, and evaluation of a theory-based educational intervention based on the mobile app to promote cervical cancer prevention behaviors
-
Public title
-
The effect of mobile application-based educational intervention on promoting cervical cancer prevention behaviors
-
Purpose
-
Prevention
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Married women of childbearing age 18-49 (having married at least once regardless of their current marital status)
Resident of Ramsar
Having a smartphone and knowing how to use it
Has not received training before the intervention
literate
Exclusion criteria:
Opt out of study
Patients with learning disabilities
-
Age
-
From 18 years old to 49 years old
-
Gender
-
Female
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
210
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
The sampling method was used to randomize the samples. Envelopes will be ready, printed, and embedded in the envelope by a member of the research team and random numbers on the Randomaize.com site. The envelopes will be closed and their contents will not be visible. Then the researcher explains the purpose of the study by phone for people who were eligible to enter the study. If the person is willing to participate in the study, she will be required to submit the informed consent form by email or the contact number registered on one of the social networks, such as Telegram and WhatsApp. Then the applicant is allowed to the researcher to open an envelope on his behalf. The researcher then unpacks the envelope and, based on the contents of the envelope, the applicant will be categorized for the intervention or control group.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Educational intervention in the field of promoting cervical cancer prevention behaviors through smart mobile application software.
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2021-05-24, 1400/03/03
-
Ethics committee reference number
-
IR.MODARES.REC.1400.049
Health conditions studied
1
-
Description of health condition studied
-
Cervical cancer
-
ICD-10 code
-
C53.9
-
ICD-10 code description
-
Malignant neoplasm of cervix uteri, unspecified
Primary outcomes
1
-
Description
-
Preventive measures for cervical cancer
-
Timepoint
-
Measurement of behavior before intervention,Immediately after intervention, and 3 months after intervention
-
Method of measurement
-
Use of preventive behaviors questionnaire to promote cervical cancer
2
-
Description
-
Knowledge about the preventive behaviors of cervical cancer
-
Timepoint
-
Measurement of awareness before intervention, Immediately after intervention, and 3 months after the intervention
-
Method of measurement
-
Use of preventive behaviors questionnaire to promote cervical cancer
3
-
Description
-
Motivation for preventive behaviors of cervical cancer
-
Timepoint
-
Measurement of motivation before the intervention, Immediately after the intervention, and 3 months after the intervention.
-
Method of measurement
-
Use of preventive behaviors questionnaire to promote cervical cancer
4
-
Description
-
Behavioral intention to prevent cervical cancer
-
Timepoint
-
Measurement of action to preventive bahavior before the intervention, Immediately after the intervention, and 3 months after the intervention.
-
Method of measurement
-
Use of preventive behaviors questionnaire to promote cervical cancer
5
-
Description
-
Information Factors Related to Cervical Cancer Preventive Behaviors
-
Timepoint
-
Measurement of Information factors to preventive bahavior before the intervention, Immediately after the intervention, and 3 months after the intervention.
-
Method of measurement
-
Use of preventive behaviors questionnaire to promote cervical cancer
6
-
Description
-
Predisposing factors cervical cancer preventive behaviors
-
Timepoint
-
Measurement of predisposing factors to preventive bahavior before the intervention, Immediately after the intervention, and 3 months after the intervention.
-
Method of measurement
-
Use of preventive behaviors questionnaire to promote cervical cancer
Intervention groups
1
-
Description
-
Intervention group 1: Educational content on preventive behaviours on cervical cancer is prepared based on the effective structures of I-Change theory, which will be obtained from the qualitative and review phase. The educational content designed in the form of an educational application is installed in the smartphones of the intervention group (women 18-49 years old). Educational content through online group teaching methods, Q&A and collaborative learning, problem-solving, talking about positive experiences, posters, brochures, photos, videos and educational slides, retelling memories, etc. in the context of the mobile application will be provided.
-
Category
-
Behavior
2
-
Description
-
Intervention group 2: This group will receive the educational intervention in accordance with the conceptual framework resulting from the influential structures of I-Change theory in digital form.
-
Category
-
Behavior
3
-
Description
-
Control group: After evaluating and comparing the two educational interventions, based on ethical principles, this group will also receive the desired interventions.
-
Category
-
Behavior
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Faculty of Medical Sciences, Tarbiat Modares University
-
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
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
-
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
-
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
-
Part of the data on the main consequences can be shared.
-
When the data will become available and for how long
-
Access period starts 6 months after the results are published
-
To whom data/document is available
-
The data will be available only to researchers working in academic and scientific institutions.
-
Under which criteria data/document could be used
-
Repeated measurement analysis to evaluate the duration of training 6 months after the last intervention
-
From where data/document is obtainable
-
By sending an email to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir
-
What processes are involved for a request to access data/document
-
One week after sending the email by the applicant to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir will be answered.
-
Comments
-