Protocol summary

Summary
This study is a randomized clinical trial study in 2016 to evaluate the effect of Health Belief model-based education through online mobile messaging application on Bushehrian women's beliefs and performances related to Pap smear experiment. inclusion criteria: literacy; having a smart phone and telegram messaging application; passing at least six months of marriage, lack of/not doing of Pap smear in past three years. Exclusion criteria: unwillingness to participate in the study, presence of cervical cancer or other cancers in the genital tract, presence of hysterectomy history. Sampling method has two-stages, so that, among 10 health care centers in Bushehr, 4 centers have been selected randomly. After referring to the above mentioned medical centers, a list of people with inclusion criteria for participating in the present study has been provided and compatible with the number of each center's candidates, our samples have been selected randomly. Finally, the selected candidates will be divided into two intervention and control groups. The population of study includes 20-50 years old women with a sample size of 106. Monthly intervention to intervention group, has been done by sending health beliefs model-based educational content via telegram application. The intervention and control groups candidates ( 53) completed the questionnaire in three different intervals, before, immediately after and three month after training. Finally, three months after training, the candidates will be tested due to pap smear.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016062928702N1
Registration date: 2016-08-13, 1395/05/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-08-13, 1395/05/23
Registrant information
Name
Farzane Khademolhosseini
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 3345 0178
Email address
f.khademolhosseini@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Bushehr University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the effect of training Health Belief model-based education through online mobile messaging application on Bushehrian women's beliefs and performances related to Pap smear experiment
Public title
The impact of training to do pap smear for early dignosis of cervical cancer
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: literacy; having a smart phone and telegram messaging application; passing at least six months of marriage, lack of/not doing of Pap smear in past three years. Exclusion criteria: unwillingness to participate in the study, presence of cervical cancer or other cancers in the genital tract, presence of hysterectomy history.
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 106
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 Bushehr University of Medical Science
Street address
Bahmani, Salman Farsi Street Bushehr University of Medical Sciences Campus site
City
Bushehr
Postal code
Approval date
2016-06-26, 1395/04/06
Ethics committee reference number
IR.BPUMS.REC.1395.57

Health conditions studied

1

Description of health condition studied
Cervical Cancer
ICD-10 code
C53
ICD-10 code description
Malignant Neoplasm of Cervix uteri

Primary outcomes

1

Description
Doing Pap SmearTest
Timepoint
Before and after three months of training
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Knowledge of Cervical Cancer
Timepoint
Before, immediately and after three months training
Method of measurement
Questionnaire

2

Description
Perceived Susceptibility
Timepoint
Before, immediately and after three months training
Method of measurement
Questionnaire

3

Description
Perceived Severity
Timepoint
Before, immediately and after three months training
Method of measurement
Questionnaire

4

Description
Perceived Benefits
Timepoint
Before, immediately and after three months training
Method of measurement
Questionnaire

5

Description
Perceived Barriers
Timepoint
Before, immediately and after three months training
Method of measurement
Questionnaire

6

Description
Health Motivation
Timepoint
Before, immediately and after three months training
Method of measurement
Questionnaire

Intervention groups

1

Description
The participants of intervention group receives health belief model-based training content within one month through telegram messenger application.
Category
Prevention

2

Description
The control group doesn't receive any training.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
7 Tir Clinical Health Center
Full name of responsible person
Sarkhosh Zinat
Street address
Sangi st - Bushehr
City
Bushehr

2

Recruitment center
Name of recruitment center
Nabi Akram Clinical Health Center
Full name of responsible person
Baharestani Maryam
Street address
Three-way Bazargani - Motahari St-Bushehr
City
Bushehr

3

Recruitment center
Name of recruitment center
Ghods Clinical Health Center
Full name of responsible person
Leila Svamry
Street address
22 Mehre SrوEmamzadeh Sector, Bushehr
City
Bushehr

4

Recruitment center
Name of recruitment center
Ali Ibn Abi Talib Clinical Health Center
Full name of responsible person
Sodabe Zalpoor
Street address
Kooti Sector, Sr Coastal, Bushehr
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Bushehr University of Medical Sciences
Full name of responsible person
Afshin Ostovar
Street address
Bushehr University of Medical Sciences, Salman Farsi St, Bahmani, Bushehr, Iran
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Bushehr 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
Bushehr University of Medical Sciences, Salman Farsi St, Bahmani, Bushehr, Iran
Full name of responsible person
Azita Noroozi
Position
Ph.D. of Health Education
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Salman Farsi St, Bahmani, Bushehr, Iran
City
Bushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Fax
+98 77 3332 3123
Email
azitanoroozi@yahoo.com
Web page address
www.bpums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences, Bushehr, Iran
Full name of responsible person
Azita Noroozi
Position
Ph.D. of Health Education
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Salman Farsi St, Bahmani, Bushehr, Iran
City
Bushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Fax
+98 77 3332 3123
Email
azitanoroozi@yahoo.com
Web page address
www.bpums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bushehr University of Medical Sciences, Bushehr, Iran
Full name of responsible person
Farzane Khademolhosseini
Position
MSc Student of Health Education
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Salman Farsi St, Bahmani, Bushehr, Iran
City
Bushehr
Postal code
Phone
+98 77 3332 2081
Fax
+98 77 3332 3123
Email
fkhadem67@gmail.comf.khademolhosseini@bpums.ac.ir
Web page address
www.bpums.ac.ir

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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