The effect of human papillomavirus prevention and treatment training based on the planned behavior model on the knowledge and attitude of women of reproductive age
The effect of education for prevention and treatment of human papillomavirus based on the model of planned behavior on the knowledge and attitude of women of reproductive age referred to comprehensive health centers in Shiraz in 1401-1400
Design
A randomized controlled clinical trial will be performed on 90 women of reproductive age referred to Shiraz Comprehensive Health Centers using Spss 22 software.
Settings and conduct
In selected comprehensive health centers of Shiraz, women aged 15 to 49 years are assigned to the intervention and control groups based on 6-block randomization by applying the entry conditions. The study is educational and has not been blinded
Participants/Inclusion and exclusion criteria
Admission requirements: resident of Shiraz, literate, no membership in the treatment team and no history of hysterectomy and sexually transmitted diseases and also not attending similar training classes; Conditions of non-entry: unwillingness to participate in the study, non-participation in more than one training session and change of residence
Intervention groups
The intervention is in the form of training and presentation of a related educational booklet that is given to the intervention group. The control group will not receive any training, but at the end of the study, an educational booklet will be presented to Atan
Main outcome variables
Knowledge and attitude of women of reproductive age before and after the intervention are assessed and compared with the control group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220131053891N1
Registration date:2022-04-28, 1401/02/08
Registration timing:registered_while_recruiting
Last update:2022-04-28, 1401/02/08
Update count:0
Registration date
2022-04-28, 1401/02/08
Registrant information
Name
Fatemeh Vizeshfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4258
Email address
vizeshfar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of human papillomavirus prevention and treatment training based on the planned behavior model on the knowledge and attitude of women of reproductive age
Public title
Evaluation of the effect of education in the prevention and treatment of human papillomavirus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women 15_49 years
Resident of Shiraz
No membership in the treatment team
Literate
Having a Smartphone
No history of neurological disease
No history of hysterectomy and sexual transmitted disease
No cervical cancer
Exclusion criteria:
Participate in similar training classes
History of HPV
Reluctance to participate in further study
Change of residence
Dont attend more than one training session
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Among the comprehensive health centers of Shiraz, several centers are determined randomly and by lottery. Then, by determining the number of women of childbearing age referring to each center, the number of samples of each center will be allocated as a quota. After that, according to Apple's electronic file information, eligible women will be randomly invited to participate in the study. Finally, the samples are divided into two groups of intervention and control by block randomization method. For this purpose, randomization will be done for 90 people using the list randomization site and 6 blocks
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 Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Boulevard, in front of Palestine Street
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2022-03-14, 1400/12/23
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1400.080
Health conditions studied
1
Description of health condition studied
Icd_10
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
People's knowledge and attitude score
Timepoint
Before the educational intervention, immediately and three months after the intervention
Method of measurement
Standard human papillomavirus and its vaccine questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After completing the informed consent form and pre-test questionnaire by group members, 3 training sessions of 30 to 45 minutes on the importance of prevention and vaccination of human papillomavirus and existing treatment methods weekly and in small groups (due to conditions Pandemic Quidd 19) will be held. An educational booklet is also given to these people. The duration of the course from the beginning of the intervention to the completion of the last questionnaire will be 3 months. In fact, after the educational intervention, the test will be held immediately and 3 months later, in order to check the reliability of the training, individuals are again asked to complete the questionnaire.
Category
Prevention
2
Description
Control group: will not receive any training during the study. After completing the last questionnaire, in order to maintain the principles of ethics in research, a booklet containing educational materials will be presented to them.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Comprehensive Health Centers
Full name of responsible person
Fatemeh Vizeshfar
Street address
Hazrat Fatemeh School of Nursing and Midwifery, Namazi Square, Zand Boulevard
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4252
Email
Vizeshfar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Memarpour Mahtab
Street address
Zand Boulevard, in front of Palestine Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Fax
Email
Memarpour@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Vizeshfar Fatemeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazi Square, Zand Boulevard
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4252
Email
Vizeshfar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Vizeshfar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazi Square. Zand Boulevard
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4252
Email
Vizeshfar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Vizeshfar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazi Square, Zand Boulevard
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4258
Email
Vizeshfar@yahoo.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
Not applicable
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
Outcome information can be shared under the supervision of the first author or facilitator after the subjects being unidentified
When the data will become available and for how long
3 months after printing the results
To whom data/document is available
Researchers with a license and code of ethics can apply
Under which criteria data/document could be used
Researchers who have an approved plan and intend to work in review, retrospective or meta-analysis
From where data/document is obtainable
Via emails; Leilarafiei64@yahoo.com and Vizeshfar@yahoo.com
and researchers who do not have distance problems by referring to the School of Nursing, Department of Education
What processes are involved for a request to access data/document
After receiving the message, the result will be sent up to one week