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Investigating the Impact of the Educational Intervention on Knowledge, Perception and Screening of Cervical Cancer in Women

Protocol summary

Study aim
The general aim of the project is to investigate the effect of educational intervention on awareness, understanding and screening of cervical cancer in women of Khash city in 1402.
Design
The clinical trial has a control group, with factorial groups, a work strain, random assignment to intervention and control groups on 90 people and is used by Excel and SPSS software.
Settings and conduct
The basis of educational planning in this research will be based on an active learning approach. After coordinating the place and time of the training, which is in the health centers of Khash city, the relevant group will be invited to participate in the program. Then the case group will participate in three training sessions. The educational method will be in the form of lectures and questions and answers, and educational clips will also be used.
Participants/Inclusion and exclusion criteria
All women between the ages of 18 and 60 referring to the health centers of Khash city have the condition to enter the study. Since this study does not have a serious risk, therefore, there is no condition of non-entry and we only consider the age limit.
Intervention groups
The intervention group will participate in three training sessions. The educational content will be adjusted according to the reliable sources of the Ministry of Health. The educational method will be in the form of lectures and questions and answers, and the educational clip that will be sent to the intervention group through internal messengers will be used. Regarding the control group, there is no training and they are only examined in the final exam.
Main outcome variables
With the success of the program, we will provide effective solutions to recognize and control the disease and the factors involved in it, which will help the disease control program in the long run.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230926059529N1
Registration date: 2023-10-17, 1402/07/25
Registration timing: prospective

Last update: 2023-10-17, 1402/07/25
Update count: 0
Registration date
2023-10-17, 1402/07/25
Registrant information
Name
Osama Kord
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3376 0000
Email address
osamakord0699@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Impact of the Educational Intervention on Knowledge, Perception and Screening of Cervical Cancer in Women
Public title
Investigating the Effect of Educational Intervention on Cervical Cancer Knowledge
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All Women Aged 18 to 60 Referring to Health Centers in Khash City
Exclusion criteria:
People who visit the base at a time other than what is predetermined. People who have various mobility disabilities and cannot wait at the base.
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Among the 3 comprehensive urban health service centers of Khash, one center will be selected as an intervention center and one as a control center by simple random. Then, 45 people from each of the centers will be randomly selected from the list of eligible women covered and entered into the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the said trial, all participants were blind and would not know how the groups were assigned. In such a way that the grouping of people will not be provided to them.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Persian Gulf Blvd., Dr. Hasabi Square, University of Medical Sciences Campus, Central Headquarters Building, 2nd Floor
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9891915399
Approval date
2023-08-27, 1402/06/05
Ethics committee reference number
IR.ZAUMS.REC.1402.221

Health conditions studied

1

Description of health condition studied
Cervical Cancer in Women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cervical cancer knowledge score in Alam et al.'s 2007 questionnaire
Timepoint
Calculate the knowledge score before and after the intervention
Method of measurement
Alam et al.'s 2007 questionnaire

2

Description
Cervical cancer perception score in Alam et al.'s 2007 questionnaire
Timepoint
Calculate the perception score before and after the intervention
Method of measurement
Alam et al.'s 2007 questionnaire

3

Description
Cervical cancer screening score in Alam et al.'s 2007 questionnaire
Timepoint
Calculate the screening score before and after the intervention
Method of measurement
Alam et al.'s 2007 questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, educational content will be developed based on the guidelines of the Ministry of Health, reputable articles and books, and educational booklets. The topics of the training sessions include understanding cervical cancer, the importance of screening and self-care in prevention, addressing social misconceptions and dispelling taboos about cervical cancer. In this study, visual educational technologies such as films, photos, visual handouts, and interactive exercises will be utilized to allow participants to share their experiences and knowledge and learn from others through observation. The visual validity of the educational materials will be determined through a review by a ten-member panel consisting of experts such as doctors, nurses, health educators, and patients. The training sessions will be conducted by a health specialist at comprehensive health service centers. Each session is expected to last an average of 50-60 minutes, with a maximum of 15 participants in each group. At the beginning of the study, control group patients will receive four consecutive educational sessions over four days, followed by a one-hour session every three months until the end of the study for follow-up and reinforcement of preventive behaviors. In total, six educational sessions will be conducted throughout the study.
Category
N/A

2

Description
Control group: Control group: In the control group, there is no special intervention. The information of the people of this group, such as demographic data and specific data, will be archived after their identification, so that after the end of the educational intervention in the intervention group, it will be compared with the data found in the intervention group and used in the conclusion of the research.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Khash Urban Health Base
Full name of responsible person
Hossein Izadi Raad
Street address
Inghelab St., Khash
City
Khash
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 911 270 5811
Email
izadi111389@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noormohammed Bakhshani
Street address
Persian Gulf Blvd., Dr. Hesabi Square, University of Medical Sciences Campus, Central Headquarters Building, 2nd Floor
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9891915399
Phone
+98 54 3337 2116
Email
zaums.research@gmail.com
Web page address
https://research.zaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Osama Kord
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Public Health
Street address
Sistan and Baluchistan province, Khash city, Central part, Akbarabad village
City
Khash
Province
Sistan-va-Balouchestan
Postal code
9885113136
Phone
+98 54 3376 0000
Fax
Email
osamakord0699@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Osama Kord
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Public Health
Street address
Sistan and Baluchistan province, Khash city, Central part, Akbarabad village
City
Khash
Province
Sistan-va-Balouchestan
Postal code
9885113136
Phone
+98 54 3376 0000
Fax
Email
osamakord0699@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Osama Kord
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Public Health
Street address
Sistan and Baluchistan province, Khash city, Central part, Akbarabad village
City
Khash
Province
Sistan-va-Balouchestan
Postal code
9885113136
Phone
+98 54 3376 0000
Fax
Email
osamakord0699@gmail.com

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
All participant data files will be shared after de-identification. The study protocol will be fully shared. The statistical analysis map will be fully shared. The informed consent form will be fully shared. The clinical study report will be fully shared. The codes used in the analysis will be fully shared. The data classification system will be fully shared.
When the data will become available and for how long
The start of the period of access to the study data will be approximately 6 months after the publication of the research results.
To whom data/document is available
The data of this research is only available for working and non-working researchers and students.
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
Applicants can contact the researcher through the email address and request the data. First e-mail address of the researcher (default): osamakord0699@gmail.com Second e-mail address of the researcher (only if the default e-mail is not available): osamakord0699@outlook.com
What processes are involved for a request to access data/document
The data requester will receive a response within 3 business days after clearly presenting his request via email
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