Effect of group counseling based on protection-motivation theory versus no counseling on cervical cancer screening in postmenopausal women: a randomized clinical trial
To assess the effect of group counseling based on protection-motivation theory versus no counseling on cervical cancer screening in postmenopausal women
Design
This is a randomized clinical trial, phase II, in which 108 eligible postmenopausal women will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible postmenopausal women who will refer to Hamedan Comprehensive Health Center during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 50 to 60 years;
Cessation of menstruation for more than a year;
Literate.
Exclusion criteria:
Physical or mental diseases;
A history of cancer in the patient or her family;
A history of regular screening;
A previous history of counseling.
Intervention groups
Intervention group: Routine care and group counseling based on protection-motivation theory for 45 to 60 minutes per week for 4 weeks.
Control group: Just routine care.
Main outcome variables
Primary outcome: participants' attitude and function toward cervical cancer screening
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N251
Registration date:2018-11-22, 1397/09/01
Registration timing:registered_while_recruiting
Last update:2018-11-22, 1397/09/01
Update count:0
Registration date
2018-11-22, 1397/09/01
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of group counseling based on protection-motivation theory versus no counseling on cervical cancer screening in postmenopausal women: a randomized clinical trial
Public title
Effect of group counseling based on protection-motivation theory versus no counseling on cervical cancer screening in postmenopausal women
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 50 to 60 years;
Cessation of menstruation for more than a year;
Being literate
Exclusion criteria:
Physical or mental diseases;
A history of cancer in patient or her family;
A history of regular screening;
A previous history of counseling.
Age
From 50 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots
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
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-11-03, 1397/08/12
Ethics committee reference number
IR.UMSHA.REC.1397.495
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
Participants' attitude and function toward cervical cancer screening
Timepoint
Before and after group counseling
Method of measurement
Using a standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care and group counseling based on protection-motivation theory for 45 to 60 minutes per week for 4 weeks
Category
Other
2
Description
Control group: Just routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan Comprehensive Health Center
Full name of responsible person
Sorooh Rahmani
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sr.rahmani63@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Sorooh Rahmani
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sr.rahmani63@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Maternal and Child Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
pparsa2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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