Protocol summary

Summary
Cervical cancer screening leads to early detection, timely treatment and prevent complications, mortality from this disease. In rural women barriers of screening tests are higher than urban women. The aim of this study was to determine the effect of counseling on health belief model on screening for cervical cancer in rural women in Kaboudarahang city in 2015-2016. A multi-stage random cluster survey used to select women. Eighty married women above 20 years (40 cases and 40 cases in the control group) will select rendomly from health care centers of Kaboudarahang city, Hamadan. In the both groups ( case and control groups) data will collect using questionnaires about demographic background, knowledge, beliefs and practices about cervical cancer prevention. In case group, three sessions of group counseling of cervical cancer screening every week will take part. Follow-up will done two months after the intervention. Both groups will compared before and after the intervention.

General information

Acronym
Health Belief Model- Screening- cervical cancer- rural women
IRCT registration information
IRCT registration number: IRCT2015110410426N8
Registration date: 2015-12-21, 1394/09/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-21, 1394/09/30
Registrant information
Name
Parisa Parsa
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 4396
Email address
parsa@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research and Technology ,Hamadan University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling based on Health Belief Model on cervical cancer screening to rural women
Public title
The effect of group counseling based on Health Belief Model on cervical cancer screening among rural women in Kabudarahang city in 2015-2016.
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria comprised: At least in the rural areas during the last two years؛ married women؛ divorced women؛ widows women؛ not underwent to hysterectomy, no family history of cervical cancer . Exclusion criteria comprised: The absence of regular group counseling sessions؛ change residency to other location.
Age
From 20 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
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 Hamadan University of Medical Sciences
Street address
Hamadan-Shahid Fahmideh Avenue- Hamadan University of Medical Sciences
City
Hamadan
Postal code
6517838698
Approval date
2015-07-27, 1394/05/05
Ethics committee reference number
IR.UMSHA.REC.1394.213

Health conditions studied

1

Description of health condition studied
Cevix cancer screening
ICD-10 code
Z01.4
ICD-10 code description
Gynaecological examination (general)(routine)

Primary outcomes

1

Description
Cervical Cancer Screening (Pap Smear)
Timepoint
Before, Immediately and Two months after intervention
Method of measurement
Undergoing Pap Smear Test

Secondary outcomes

1

Description
Promote of womens' health beliefs on cervical cancer screening
Timepoint
Before, immediately after and two months after intervention
Method of measurement
Health beliefs score

Intervention groups

1

Description
In the intervention group: rural women will participate the three sessions of group counseling in small groups of 5-7 people in an hour weekly . Counseling contents include of the definition of cervical cancer, symptoms, risk factors predisposing factors, disease problems, screening for cervical cancer. Believe and practice evaluation of cervical screening will assess prior to, immediately after and two months after intervention.
Category
Prevention

2

Description
In the control group no intervention shall be made. Evaluation of the belief and practice of cervical cancer screening will made as same as intervention group at prior to, immediately after, and two months after the intervention.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Care Center of Kabudrahang City
Full name of responsible person
Dr. Parisa Parsa
Street address
Kabudrahang- Health Care Center of Kabudrahang City
City
Kabudrahang

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chanslor of Research in Hamadan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences- Shahid Fahmideh Street- Counterpoint of Mardom Park- Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanslor of Research in Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Assistant Professor
Other areas of specialty/work
Street address
Research Center for Chronic Diseases Home Care, Hamadan University of Medicine and Health Sciences, Shahid Fahmideh Street- Counterpont of Mardom Park- Hamadan
City
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Fax
Email
parsa@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Assistant Professor
Other areas of specialty/work
Street address
Research Center for Chronic Diseases Home Care, Hamadan University of Medicine and Health Sciences, Shahid Fahmideh Street- Counterpont of Mardom Park- Hamadan
City
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Fax
Email
Parsa@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Assistant Professor
Other areas of specialty/work
Street address
Research Center for Chronic Diseases Home Care, Hamadan University of Medicine and Health Sciences, Shahid Fahmideh Street- Counterpont of Mardom Park- Hamadan
City
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Fax
Email
Parsa@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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