Protocol summary

Study aim
Design, implementation and evaluation of the effect of training program on cervical cancer screening behavior in women of reproductive age 18-49 years
Design
Sample size obtained using the formula n = ((Z_ (1-α / 2) + Z_ (1-β)) ^ 2 (δ_1 ^ 2 + δ_2 ^ 2)) / (µ_1-µ_2) ^ 2 Thirty-six patients were included, accounting for 15% of the probability of loss for the 42 group. Randomization of the samples will be done to maintain equilibrium in the number of subjects belonging to the control and intervention groups and to obtain the maximum power in the study using a randomized block design with four blocks. These duplicate random blocks will be performed for each cluster individually.
Settings and conduct
At this stage, to obtain a random sample that represents all women in the city; a sample of Andimeshk women in order to achieve the status of knowledge, attitude, self-efficacy, and performance of women in Pap smear screening, setting up, and providing targeted educational content. The second phase will be studied.
Participants/Inclusion and exclusion criteria
Inclusion criteria 1. Women of childbearing age 18-49 (who have been married at least once, regardless of their current marital status), Resident of Andimeshk 3. Minimum literacy reading and writing 4. Has a minimum age of 18 years and a maximum of 49 years 5. Written consent to participate in the study Exclusion criteria 1. Cervical cancer or other STDs 2. Opt out of study 3. Inability to read and write
Intervention groups
All women who qualify for the study will be given a pre-test. After completing the questionnaire, individuals will be divided into intervention and control groups according to their evaluation and mean score. The control group will not be given specific action or training.
Main outcome variables
Promoting Knowledge, Attitude, Self-efficacy, and Practice About Cervical Cancer Screening

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191206045626N1
Registration date: 2020-02-12, 1398/11/23
Registration timing: prospective

Last update: 2020-02-12, 1398/11/23
Update count: 0
Registration date
2020-02-12, 1398/11/23
Registrant information
Name
shahnaz ghalavandi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 61 4269 0656
Email address
ghalavandishahnaz@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-19, 1398/12/29
Expected recruitment end date
2020-06-18, 1399/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, Implementation and Evaluation of a Cervical Cancer Prevention Behavior Training Program for Women of Reproductive Age 18-49 in Andimeshk in 1399-1998
Public title
Design, Implementation and Evaluation of a Cervical Cancer Prevention Behavior Training Program for Women of Reproductive Age
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 Andimeshk Minimum literacy Minimum 18 years and maximum 49 years Written consent to participate in the study
Exclusion criteria:
Cervical cancer or other STDs 2.Opt out of study 3.Inability to read and write
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: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of the samples will be done in order to maintain equilibrium in the number of subjects belonging to the control and intervention groups and to obtain maximum power in the study using a randomized block design with 4 blocks. These duplicate random blocks will be performed for each cluster individually.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a two-stage study; the first stage is a cross-sectional descriptive study with the aim of determining knowledge, attitude, self-efficacy and practice about cervical cancer of women of reproductive age 18-49 in Andimeshk. The second phase of an experimental study with a control group with the overall aim of evaluating a cervical cancer screening training (Pap smear) training program in women of reproductive age 18-49 years in Andimeshk. First, all women who met the inclusion criteria. After completing the questionnaire, the subjects will be divided into two intervention and control groups according to their evaluation and mean score.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tarbiat Modarres University
Street address
Jalal Al Ahmad Street,district Nasr,Tarbiat Modares University,Faculty of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2020-01-21, 1398/11/01
Ethics committee reference number
IR.MODARES.REC.1398.200

Health conditions studied

1

Description of health condition studied
Screening for cervical cancer(Pap smear)
ICD-10 code
C53
ICD-10 code description
Malignant neoplasm of cervix uteri

Primary outcomes

1

Description
Improve cervical cancer screening behavior
Timepoint
Before the intervention, one month and three months after the intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group in this study consisted of 42 people who scored less than average after the pre-test; the intervention in this study will be educational. After completing the first phase of the study (cross-sectional) and assessing the educational needs of the questionnaire, the educational content will be formulated in 4 constructs of knowledge, attitude, self-efficacy and performance. And will be delivered in 3 training sessions for one month.
Category
Behavior

2

Description
Control group: The control group in this intervention consisted of 42 subjects who received a mean and higher score after the pre-test; no intervention for the control group. Post-test will be performed by Pap smear screening questionnaire from both intervention and control groups. This post-test will also be repeated 3 months after the end of training for both groups.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Andimeshk city health and treatment network
Full name of responsible person
Alireza Heidarnia
Street address
Jalal Al Ahmad Street, Nasr district, Tarbiat Modares University, Faculty of Medical Sciences
City
Andimeshk
Province
Khouzestan
Postal code
14115-111
Phone
+98 21 8288 3108
Email
ghalavandishahnaz@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modarres University, Vice Chancellor Research
Full name of responsible person
Yaghoub Fathollahi
Street address
Jalal Al Ahmad Street, Nasr district, Tarbiat Modares University, Faculty of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 2009
Email
ghalavandishahnaz@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modarres University, Vice Chancellor Research
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
Alireza Heidarnia
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal Al Ahmad Street, Nasr district, Tarbiat Modares University, Faculty of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3108
Email
ghalavandishahnaz@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Alireza Heidarnia
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal Al Ahmad Street, Nasr district, Tarbiat Modares University, Faculty of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3108
Email
ghalavandishahnaz@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Alireza Heidarnia
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal Al Ahmad Street, Nasr district, Tarbiat Modares University, Faculty of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3108
Email
ghalavandishahnaz@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
In this study, data can be shared after people are unrecognizable. Statistical analysis and intervention program reporting will also be shared.
When the data will become available and for how long
+Access to study documentation will begin 6 months after the results are published.
To whom data/document is available
Study documentation will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Study documentation will be available only to researchers working in academic and scientific institutions and will not be available to others.
From where data/document is obtainable
1. Dr. Alireza Heidarnia, Professor of Health Education, Tarbiat Modares University email: hidarnia@modares.ac.ir 2- Shahnaz Ghavavandi MSc Student of Health Education, Tarbiat Modarres University email: ghalavandishahnaz@modares.ac.ir
What processes are involved for a request to access data/document
Writing the request clearly defines what part of the applicant's actual need is to study the documentation. Submit request via email provided in the study.
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