Determining the Effect of Education Based on the Process of Changing Steps on the Sexual Behavior of Postmenopausal Women
Design
In this study, we selected 108 postmenopausal women who have entered the study and are divided into two groups: intervention and control
Settings and conduct
This study was conducted in Mashhad health centers and on 108 postmenopausal women divided into intervention and control groups. The intervention group received education and the control group did not receive any training.
Participants/Inclusion and exclusion criteria
Written consent for participation in research
Iranian nationality and resident of Mashhad city
Women aged 45-65 years
Married and not at all
Natural menopause and at least 1 and more than 5 years of menstrual cessation
Living a woman with her husband
Earn more than 28 scores from Women's Sexual Function Questionnaire
Literacy reading and writing
No history of infertility
The absence of physical problems in a woman or her husband
Non-use of drugs that affect the sexual function of a woman or her husband
Not having bad stress over the past month
No history of pelvic surgery or irradiation of the reproductive system
Missing rape history
Not having Drug addiction to alcol
Lack of education about sexual issues
Intervention groups
This study was performed with two intervention and control groups, each containing 54 postmenopausal women. The educational control group is not conducted, but the training sessions will be held for the intervention group.
Main outcome variables
The main consequence of the study is the behavioral change that will occur in the sexual behavior of postmenopausal women.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170610034440N4
Registration date:2018-02-05, 1396/11/16
Registration timing:retrospective
Last update:2018-02-05, 1396/11/16
Update count:0
Registration date
2018-02-05, 1396/11/16
Registrant information
Name
azam pourmir
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 854 9787
Email address
pourmira931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
2017-08-11, 1396/05/20
Actual recruitment end date
2017-12-11, 1396/09/20
Trial completion date
empty
Scientific title
The Effect of Education Based on the Process of Changing Steps on the Sexual Behavior of Postmenopausal Women
Public title
The Effect of Education Based on the Process of Changing Steps on the Sexual Behavior of Postmenopausal Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Written consent for participation in research
Iranian nationality and resident of Mashhad city
Women aged 45-65 years
married and her only one partner
Natural menopause and at least 1 and more than 5 years of menstrual cessation
Living a woman with her husband
Earn more than 28 scores from Women's Sexual Function Questionnaire
Reading and Writing Literacy - Disregarding the history of infertility
The absence of physical problems in a woman or her husband
The absence of psychological disorders in women based on dass21 questionnaire
The lack of sexual dysfunction and prostate problems in the partner
Non-use of drugs that affect the sexual function of a woman or her husband
Not having bad stress over the past month
No history of pelvic surgery or irradiation of the reproductive system
Missing rape history
Not having Drug addiction
Lack of education about sexual issues
Exclusion criteria:
Missing more than one training session
Taking effective drugs on the sexual performance of a woman or her husband during the study
Use of sex hormones during study
The occurrence of adverse or stressful events in the study
Age
From 45 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Actual sample size reached:
108
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a quasi-experimental study with two groups of intervention and control (54 people) and pre-test, post-test. It is done in a simple random manner and available samples that are selected based on the criteria for entering the study.
Selection of the research unit based on the criteria of entry and exit was available and divided into two groups randomly through a random number table. Each group has one or two code assigned to each of the groups and assigned to each research unit two-digit code. Then in the random numbers table, the first random number selected for the first group was the second random number selected for the second group.
In each group, on the first day, the researcher, while introducing himself and a brief description of the research after obtaining informed consent, completed the questionnaire of the pre-test personal characteristics of the qualified individuals including the completion of the questionnaires.
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
Ethic committee of Masshad of Medical Sciences
Street address
Daneshgah Street .Mashhad of Medical Science
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.MUMS.REC.1396.49
Health conditions studied
1
Description of health condition studied
Sexual behaviors in postmenopausal women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The score sexual behavior menopausal women is based on Mc Coy Female Sexuality Questionaire
Timepoint
Measuring sexual behavior at the beginning of the study (before starting the intervention), and after 2 months after intervention
Method of measurement
Mc Coy Female Sexuality Questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For this group training 4 sessions 60-minute session once a week and in accordance with the stage of people's behavior.
Category
Behavior
2
Description
Control group: There is no training in this group, and only the group will receive instruction leaflets.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Moavenat of Mashhad University of medical sciences
Full name of responsible person
Azam pourmir
Street address
Ebne - Sina Street - School of nursing and midvifery Mashhad medical science
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3859 1511
Email
pourmira931@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Daneshgah Street - Mashhad science medical university
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 1882 3251
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Azam Pourmir
Position
Classy midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ebne Sina Street - School of nursing and midwifery of Mashhad medical science
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13949
Phone
+98 51 3859 1511
Email
pourmira931@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahin Tafazolim
Position
Member of the faculty of midwifery, Classy Expert in Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ebne sina Street - School of nursing and Midwifery of Mashhad medical science
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3859 1511
Email
Tafazolim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Azam Pourmir
Position
Classy Student midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ebne Sina Street - School of nursing and midwifery of Mashhad medical science
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3859 1511
Email
pourmira931@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main consequence of sharing is possible
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers of Academic Institutes
Under which criteria data/document could be used
Analyzes used in the study
From where data/document is obtainable
send mail
What processes are involved for a request to access data/document
Request to send information by sending an email to the responsible person