Comparison of Two Educational Intervention Methods With Mobile Application vs. Face-to-Face Instruction on Knowledge, Attitude, Practice, Perceived Self-Efficacy, and Adherence with Pap Smear Testing among Women Aged 30-59
Investigation and comparison of two methods of educational intervention by mobile phone application and face-to-face training in knowledge, attitude, performance, perceived self-efficacy and compliance to repeat pap smear test among women aged 30-59
Design
This study is a clinical trial (RCT) with two intervention groups and one control group. Randomized block method will be used to assign the participants to three groups. The envelope is used to hide the allocation
Settings and conduct
Entering, the target population is women (30-59) years old. The participants will announce their readiness to participate in the study through an internet call on several popular social networks.
Participants/Inclusion and exclusion criteria
1. A resident of Saveh city
2. Covered by the centers and has an active electronic file of the Sib system
3. Age between 30 and 59 years
4. Having marriage experience
5. More than 3 years have passed since the first sex
6. Obtaining a weak and average knowledge score in the first stage of study
7. Using a smart mobile phone to use virtual networks (ITA program)
8. Desire to participate in research
Intervention groups
The first intervention group: the intervention designed based on the training content obtained from the qualitative and review phase of the study will be presented using the face-to-face and in-person training method. The second intervention group: the intervention designed based on the training content obtained from the qualitative and review phase of the study with They will receive the use of the mobile phone application. Control group: they will not receive it during the educational study, after the study the educational content will be provided to them.
Main outcome variables
The average score of knowledge, attitude, performance, perceived self-efficacy and adherence to re-doing the pap smear test of women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231130060228N1
Registration date:2024-02-19, 1402/11/30
Registration timing:registered_while_recruiting
Last update:2024-02-19, 1402/11/30
Update count:0
Registration date
2024-02-19, 1402/11/30
Registrant information
Name
Leila Ahadi
Name of organization / entity
The University of Tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 86 4224 7093
Email address
leila.ahadi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-19, 1402/11/30
Expected recruitment end date
2024-08-19, 1403/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Two Educational Intervention Methods With Mobile Application vs. Face-to-Face Instruction on Knowledge, Attitude, Practice, Perceived Self-Efficacy, and Adherence with Pap Smear Testing among Women Aged 30-59
Public title
Comparison of Two Educational Intervention Methods With Mobile Application vs. Face-to-Face Instruction on Knowledge, Attitude, Practice, Perceived Self-Efficacy, and Adherence with Pap Smear Testing among Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1. A resident of Saveh city
Covered by the centers and has an active electronic file of the Sib system
Age between 30 and 59 years
Having marriage experience
More than 3 years have passed since the first sex
Obtaining a weak and average knowledge score in the first stage of study
Using a smart mobile phone to use virtual networks (ITA)
Desire to participate in research
Exclusion criteria:
1. Participation in another educational program at the same time or parallel to the intervention
Being pregnant now
Perform hysterectomy
Genital warts or cervical cancer known and under treatment
Conducting a pap smear test in the last 2 years
Conducting HPV screening tests in the last 10 years
Age
From 30 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
A list of individuals who have achieved poor and average knowledge scores will be compiled. These individuals will be numbered consecutively for random assignment to one of three groups: A, B, or C. This study will involve 120 participants. The method of permutation blocks will be employed for this purpose. We will utilize Random Allocation Software, which will be used to create 20 blocks of six. This software aids in balancing the number of samples allocated to each group under study. This feature is particularly beneficial when intermediate analyses are required during the sampling process, as it ensures an equal number of samples in each group. In this study, the blocking type is consistent across all blocks. Out of the total 120 participants, groups A (control group), B (intervention group receiving face-to-face training), and C (intervention group receiving training via a mobile phone application) will each be assigned 40 participants. Upon selection of the samples, they will be contacted. A brief overview of the study, its objectives, the teaching method, and the criteria for inclusion and exclusion from the study will be provided. If they are willing to participate, they will be included in the study. If they decline, the next individual will be contacted. Written consent will be obtained from all participants agreeing to participate in the study.
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 Tarbiat Modares University
Street address
Jalal Al Ahmad Street, Nasr Bridge, Tarbiat Modares University, Faculty of Medicine
City
Tehran
Province
Tehran
Postal code
111-14115
Approval date
2023-11-18, 1402/08/27
Ethics committee reference number
IR.MODARES.REC.1402.171
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
Knowledge score in the Farsi version of cervical cancer screening self-efficacy questionnaire
Timepoint
Before the intervention, immediately, one month later and three months after the intervention
Method of measurement
Persian version of cervical cancer screening self-efficacy questionnaire
2
Description
Attitude score in the Persian version of cervical cancer screening self-efficacy questionnaire
Timepoint
Before the intervention, immediately, one month later and three months after the intervention
Method of measurement
Persian version of cervical cancer screening self-efficacy questionnaire
3
Description
Self-efficacy score in the Farsi version of cervical cancer screening self-efficacy scale
Timepoint
Before the intervention, immediately, one month later and three months after the intervention
Method of measurement
Persian version of cervical cancer screening self-efficacy questionnaire
4
Description
Practice score in the Farsi version of cervical cancer screening self-efficacy questionnaire
Timepoint
Before the intervention, immediately, one month later and three months after the intervention
Method of measurement
Persian version of cervical cancer screening self-efficacy questionnaire
5
Description
Adhereance to action score in Persian version of the Adhereance to action pap smear
Timepoint
Before the intervention, immediately, one month later and three months after the intervention
Method of measurement
Persian version of the Adhereance to action pap smear
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group of the intervention will be in such a way that at first the participants will be members of the ITA group. After welcoming and introducing himself, the researcher will again remind the objectives of the research, the research team, the duration of training in this group and the timing of completing the questionnaire; Then the time and place of the first training session was announced in the groupThe schedule of training sessions will be in person one day a week. These sessions include 2 training sessions to increase members' knowledge in the field of knowledge, 2 training sessions to improve women's attitudes and beliefs regarding Pap smear testing, 2 training sessions aimed at improving women's self-efficacy regarding Pap smear testing, and 1 A training session will be held with the aim of improving the performance of women regarding the Pap smear test and 1 training session will be held regarding the improvement of compliance to the Pap smear test. After 4 weeks have passed since the beginning of the training. The post-examination process will be immediate, one month and three months later.
Category
Behavior
2
Description
Intervention group: In the second group, the intervention will be in the form that at first the participants will be members of the ITA group. After welcoming and introducing himself, the researcher will again remind the objectives of the research, the research team in this group and the schedule for completing the questionnaire, then the link to the mobile application. will be sent to them for installation. After 4 weeks from the beginning of the training. The post-test process was immediate, one month and three months later. The measurement and evaluation tools will be the same in all stages before and after the intervention
Category
Behavior
3
Description
Control group: After evaluating and comparing two educational interventions, the control group will also receive the desired intervention based on ethical principles.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Saveh Faculty Of Medical Sciences
Full name of responsible person
Leila Ahadi
Street address
Saveh University Of Medical Sciences, Jomhouri St., Saveh
City
Saveh
Province
Markazi
Postal code
۳۹۱۹۶۷۶۶۵۱
Phone
+98 86 4850 1000
Email
leila.ahadi@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Amir Abdulzadeh
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal Al Ahmad Highway, Tehran
City
تهران
Province
Tehran
Postal code
141173116
Phone
+98 21 8288 4646
Email
zadeh@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Person responsible for general inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal Al Ahmad Highway, Tehran
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4546
Email
f.zarei@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal Al Ahmad Highway, Tehran
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4546
Email
f.zarei@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal Al Ahmad Highway, Tehran
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4546
Email
f.zarei@modares.ac.ir
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
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data related to the main outcomes can be shared
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be made available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Repeated measures analysis to investigate the effect of training persistence 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 from the requester to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir, a reply will be given.