Study of the effect of giving cervical cancer screening consultation using protection motivation theory to addicted women who consume Methadone on their action to undergo the screening test
The aim of this quasi experimental study is to determine the effect of giving cervical cancer screening consultation using protection motivation theory to addicted women attending drug addiction treatment center of Hamadan city in 2015 on their action to undergo the screening test. The inclusion criteria are as follows: passing at least 3 years after the first sexual intercourse or married women over 21 years old; not having had Pap test in the past three years; not to suffer cervical cancer; and to consume Methadone. The exclusion criteria are unwillingness to continue participation in the study and receiving formal training by other organizations during the study. The samples size will be determined by census. Participants will be matched in accordance to their age and duration of addiction. Also, the participants will be divided into control and experimental groups based on random permutation method. The objectives of this study will be described to participants by the researcher. The meeting duration will be 45 to 60 minutes. Explaining the study purpose will be based on the GATHER counseling. Also consent form and questionnaire will be filled out by the participant or by the researcher through an interview if the participant is illiterate. After filling out the forms, people will be counseled and then, questionnaire will be completed again. Also this method will be done for the control group but they will not be trained. After one or two months, behavior of both groups will be assessed. This assessment will be conducted in personal meeting by examining the test sheet. After that, the questionnaire will be given to the two groups. After completion of the study, the control group will receive counseling service.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052722448N1
Registration date:2015-08-12, 1394/05/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-12, 1394/05/21
Registrant information
Name
Elham Fakouri
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 249 4556
Email address
e.fakouri@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamadan University of Medical Sciences
Expected recruitment start date
2015-06-08, 1394/03/18
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of giving cervical cancer screening consultation using protection motivation theory to addicted women who consume Methadone on their action to undergo the screening test
Public title
Study of the effect of giving cervical cancer screening consultation using protection motivation theory to addicted women attending drug addiction treatment center on their action to undergo the screening test
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: The inclusion criteria for eligibility into the study are as follows, passing at least 3 years after the first sexual intercourse or married women above 21 years; not having had Pap test in the past three years; not to suffer cervical cancer and to consume Methadone. Also the participants will be studied with their consent.
Exclusion criteria: Exclusion criteria are unwillingness of the community members to continue participating in the study and formal training by other organizations during the study.
Age
From 20 years old to 100 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The participants will be divided into control and experimental groups based on random permutation method, so that first patient of each group will be selected from drawing lots. Other members of the addicted women community are put in control and experimental groups alternately.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Hamadan University of Medical Sciences
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
Approval date
2015-02-28, 1393/12/09
Ethics committee reference number
16/35/9/6389/پ
Health conditions studied
1
Description of health condition studied
cervical cancer
ICD-10 code
c53
ICD-10 code description
Malignant neoplasm of cervix uteri
2
Description of health condition studied
consulting
ICD-10 code
Z71.9
ICD-10 code description
Counselling, unspecified
3
Description of health condition studied
drug addiction
ICD-10 code
F19
ICD-10 code description
Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances
Primary outcomes
1
Description
Pap smear and cervical cancer awareness
Timepoint
Before the intervention, immediately after the intervention, one to two months after the intervention.
Method of measurement
Researcher made questionnaire
2
Description
Self efficacy
Timepoint
Before the intervention, immediately after the intervention, one to two months after the intervention.
Method of measurement
Researcher made questionnaire
3
Description
Function
Timepoint
Before the intervention, one to two months after the intervention.
Method of measurement
Observed test papers
4
Description
Response Efficacy
Timepoint
Before the intervention, immediately after the intervention, one to two months after the intervention.
Method of measurement
Researcher made questionnaire
5
Description
Vulnerability Perceived
Timepoint
Before the intervention, immediately after the intervention, one to two months after the intervention.
Method of measurement
Researcher made questionnaire
6
Description
Perceived severity
Timepoint
Before the intervention, immediately after the intervention, one to two months after the intervention.
Method of measurement
Researcher made questionnaire
7
Description
Response costs
Timepoint
Before the intervention, immediately after the intervention, one to two months after the intervention.
Method of measurement
Researcher made questionnaire
8
Description
Motivation
Timepoint
Before the intervention, immediately after the intervention, one to two months after the intervention.
Method of measurement
Researcher made questionnaire
9
Description
Fear
Timepoint
Before the intervention, immediately after the intervention, one to two months after the intervention.
Method of measurement
Researcher made questionnaire
10
Description
Perceived rewards
Timepoint
Before the intervention, immediately after the intervention, one to two months after the intervention.
Method of measurement
Researcher made questionnaire
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: The objectives of this study will be described by researcher at a session to the participants courteously and friendly. The meeting time will be 45 until 60 minutes. Explaining the study purpose will be based on the GATHER counseling. The participants will be assured that their information will be published anonymously. After that, questionnaire will be completed. When questionnaire was be filled out by the participants, will be asked them about Pap test and their problems on this topic. Educational content that it is based on the structural model of motivation-protect, will be explained to experimental group individually. Educational content is as follow: brief description of the uterus anatomy and the cervix and genital emission, introduce groups who are at risk for cervical cancer (perceived vulnerability), the prevalence and the consequences of the disease (perceived severity), raise awareness about screening, to be referred a doctor at right time, the screening ways (perceived self-efficacy), benefits Pap test, the importance of early diagnosis (effective response) and anticipate problems and cost of the screening (the cost of the response). After that, the participants will be asked to talk about the issues and their problems. Advisor will explain the available solution. Advisor assists participant with help to decision making. If it be needed to more explanation, the benefits and costs of Pap test will be explained to participant. After consultation, questionnaire will be given to the participants again. We will request from participant for refer to us after one or two months in order to their behavior is examined.
Category
Early detection
2
Description
Control group: Members of the control group will be selected in accordance with inclusion criteria. They will receive the questionnaire without any training.
Behavior of both groups will be assessed after one month. This assessment will be conducted in personal meeting by observation of the test sheet. The questionnaire will be given to member of the control group, again. After completion of the study, the control group will receive counseling service.
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Hananeh counseling center
Full name of responsible person
Dr.Atefeh Tavana
Street address
Number 190, Mirzadeh Eshgi street, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Hamadan University of Medical Sciences
Full name of responsible person
Dr.Shamsaiee
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences, 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 Chancellor for research of 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
Nursing & Midwifery Faculty; Hamadan University of Medical Sciences.