Protocol summary

Study aim
Comparison the effect of education using compact disk versus a Messenger Service on health literacy and using screening methods of breast cancer in middle aged Iranian women
Design
In this study, 168 subjects (84 in each group) will be screened for women who are admitted to Health Center No 1 in Ahwaz. Participants will be randomly assigned a block size of 4 to two training groups via CD and training through a messenger service.
Settings and conduct
This study is a double blind randomized controlled clinical trial that will be conducted in women referred to the health center of Ahvaz. The researcher and the volunteers participating in this study will be completely unaware of being placed in each of the training groups . The method of assigning the method of teaching to randomly assigned individuals is placed by a person outside the study according to the different codes of the closed envelopes , then Allocated to any disease that is included in the study
Participants/Inclusion and exclusion criteria
Inclusion criteria :aged 59-40 ؛ having a mobile phone and installing a messenger service program for the training group with the messenger service ؛ having a CD player or computer for the CD-ROM group ؛ familiarity with the messenger service for the messenger service group ؛ The ability to read and write in Persian ؛ having poor public literacy exclusion criteria: Unwillingness to cooperate and continue research؛ pregnancy ؛ breast cancer ؛ membership in virtual groups associated with breast cancer
Intervention groups
Learning groups through the compact disk and the training group through a messenger service
Main outcome variables
health literacy ،screening methods of breast cancer

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180515039675N1
Registration date: 2018-10-01, 1397/07/09
Registration timing: registered_while_recruiting

Last update: 2018-10-01, 1397/07/09
Update count: 0
Registration date
2018-10-01, 1397/07/09
Registrant information
Name
Reihane Rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5551 3842
Email address
rajabi.r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of education using compact disk versus a Messenger Service on health literacy and using screening methods of breast cancer in middle aged Iranian women
Public title
Comparison the effect of education using compact disk versus a Messenger Service on health literacy and using screening methods of breast cancer in middle aged Iranian women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 59-40 Having a mobile phone and installing a Messenger Service Having a CD player or computer for the CD-ROM training group Familiarity with a Messenger Service Ability to read and write in persian Having low health literacy
Exclusion criteria:
Pregnancy Breast cancer Membership in virtual groups related to breast cancer
Age
From 40 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 168
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning the method of teaching to individuals is randomized and random blocked blocks with block size 4 (using the table for random permutations). Educational methods used in this research according to a randomized list by a person outside the study who is not aware of the research objectives and will be placed according to the different codes of the closed envelopes, then the code of the teaching method is assigned to each person who is included in the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and the volunteers participating in this study will be unaware of the placement of subjects in each of the training groups. The method of assigning the method of teaching to people randomly and using block randomized block blocks (block 4) using the table relating to Random permutations). Educational methods used in this research according to a randomized list by a person outside the study who is not aware of the research objectives and will be placed according to the different codes of the closed envelopes, then the code of the teaching method is assigned to each person who is included in the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences and Health Services
Street address
Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-08-19, 1397/05/28
Ethics committee reference number
IR.AJUMS.REC.1397.379

Health conditions studied

1

Description of health condition studied
breast cancer
ICD-10 code
Z12.3
ICD-10 code description
Special screening examination for neoplasm of breast

Primary outcomes

1

Description
health literacy
Timepoint
After the intervention and three months after the intervention
Method of measurement
Breast Cancer Specific health Literacy Scale

Secondary outcomes

1

Description
screening methods of breast cancer
Timepoint
After the intervention and three months after the intervention
Method of measurement
Demographic questionnaire

Intervention groups

1

Description
Intervention group:For 84 women with randomly assigned inclusion criteria will be given a compact disc. The content of this CD contains comprehensive information on various methods for screening breast cancer. To confirm the content of educational content, the content was prepared for 10 faculty members of the Jundishapur Nursing and Midwifery Faculty of Ahwaz and their corrective comments were considered.
Category
Prevention

2

Description
Intervention group: For 84 women with randomly assigned inclusion criteria, the same educational information available in the compact disc will be sent via a messenger service day by day for two weeks.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center No. 1 of Ahvaz
Full name of responsible person
Reyhaneh Rajabi Ravandi
Street address
Ahvaz Health Center، Shahid Rastegari Street، The Road to Allah Behbahani، Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8331
Email
rajabi.r@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badvi
Street address
Jundishapur University of Medical Sciences,Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 3383
Fax
+98 61 3373 3383
Email
rajabi.r@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Reyhaneh Rajabi Ravandi
Position
Masters student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Email
rajabi.r@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reyhaneh Rajabi Ravandi
Position
Master student of mifwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8331
Email
rajabi.r@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reyhaneh Rajabi Ravandi
Position
Master student of midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8331
Email
rajabi.r@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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