Protocol summary

Study aim
Comparison the effect of traditional health education with health beliefe model education on Kegel exercises in middle age women
Design
The training intervention will take place in four sessions in the form of lectures, questions, group discussions, and practical presentation. At the first and second sessions, the educational content axis will be discussed with the participants about the benefits of Cogel exercise and the importance of the risk of urinary incontinence and its complications. Including depression and withdrawal from the community that was presented in the form of lectures, questions and answersIn the third session, the educational content will include a group discussion to overcome perceived barriers (the notion of paying for exorbitant costs for participation in educational classes, and the interruption of everyday life and cultural barriers, such as staying at home in the elderly). To compare barriers with interests and to reach collective decision-making, and in the fourth session to present a practical example of Self-efficacy, by slide, shows the anatomy of pelvic floor muscle that is reinforced during exercises, and how the exercises will be performed, its benefits, and the non-interference of these exercises with daily life. At the end of the fourth session, a training booklet on the sport of Kegl They will be provided with the items taught in these 4 sessions. The purpose of this training booklet is to provide practical guidance, increase perceived sensitivity, perceived severity, perceived benefits and self-efficacy and reduce perceived barriers. . Also, a checklist will be given to the recipients for the two months to be recorded. At the end of every two weeks, a call will be made with the clients, and they will talk about the problems with the intervention, and the researchers' contact numbers will be provided to the clients
Settings and conduct
The present study is a randomized controlled trial that will be performed on 84 middle-aged women in Alvand in 1396 Before the intervention, a researcher-made questionnaire was distributed among all the units under study and the primary performance checklist was complet.Individuals will be randomly divided into two groups of 50. Samples will be selected from sampled patients from the referrals to the clinic after the initial interview and according to the criteria for entering and leaving the study. Then, through a random table, numbers will be grouped into two groups, each with one code (from one to one hundred), and then selecting them one by one, for example, one in the test group And the number two will be in the control group. Finally, 50 people will receive health-based education and 50 routine care and traditional training in health centers. And a meeting Traditional education.
Participants/Inclusion and exclusion criteria
Middle aged women30 - 45 years old married, have a child or more, have a normal birth history that is more at risk for pelvic prolapse
Intervention groups
In the experimental group, midwifery women aged 30-45 years were trained based on the health belief model. The control group, who will be women between the ages 30-45 years , will benefit from the routine care of comprehensive health centers, and will be provided with a lecture (traditional training) training session and Kagel exercises.
Main outcome variables
Conduct exercise; awareness; perceived sensitivity; perceived severity; perceived benefits; perceived barriers; action guide; self-efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171205037754N1
Registration date: 2018-05-01, 1397/02/11
Registration timing: retrospective

Last update: 2018-05-01, 1397/02/11
Update count: 0
Registration date
2018-05-01, 1397/02/11
Registrant information
Name
Kobra Hamzehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3378 4122
Email address
k.hamzehi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-30, 1396/11/10
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: Comparison the effect of traditional health education with health beliefe model education on Kegel exercises in middle age women
Public title
The effect of training in two traditional ways and using an educational model on Kagel exercises
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Middle aged women 30 - 45 years old married have a child or more have a normal birth history that is more at risk for pelvic prolapse
Exclusion criteria:
People with proven pelvic prolapse and chronic diseases include high blood pressure, diabetes, cardiovascular, pulmonary, renal psychiatric patients with a history of drug therapy
Age
From 30 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be randomly divided into two groups of 50. Samples will be selected from sampled patients from the referrals to the clinic after the initial interview and according to the criteria for entering and leaving the study. Then, through a random table, numbers will be grouped into two groups, each with one code (from one to one hundred), and then selecting them one by one, for example, one in the test group And the number two will be in the control group. Finally, 50 people will receive health-based education and 50 routine care and traditional training in health centers
Blinding (investigator's opinion)
Double blinded
Blinding description
The blinded two-way sampling method was used in which the questionnaires were not conducted by an educator who was not included in the type of groups once before the intervention, and then two months after entering the study for both groups, which they also informed about the title The team will not complete and the checklists will be delivered. And data analysis will be performed by the assessor who knows the control and intervention group.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ghazvin University of Medical Sciences
Street address
Bahonar Blvd.-Qazvin University of Medical Sciences
City
Ghazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2017-11-03, 1396/08/12
Ethics committee reference number
IR.QUMS.REC.1396.297

Health conditions studied

1

Description of health condition studied
Pelvic floor muscle weakness
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
perform Cogel exercises
Timepoint
Before and after intervention
Method of measurement
A checklist - a questionnaire

2

Description
Perceived sensitivity
Timepoint
Before and after intervention
Method of measurement
a questionnaire

3

Description
Perceived severity
Timepoint
Before and after intervention
Method of measurement
a questionnaire

4

Description
Perceived benefits
Timepoint
Before and after intervention
Method of measurement
a questionnaire

5

Description
Perceived barriers
Timepoint
Before and after intervention
Method of measurement
a questionnaire

6

Description
Action guide
Timepoint
Before and after intervention
Method of measurement
a questionnaire

7

Description
Efficacy
Timepoint
Before and after intervention
Method of measurement
a questionnaire

8

Description
awareness
Timepoint
Before and after intervention
Method of measurement
a questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A 45-30 year old spouse with a birth history-In the intervention group, an educational program based on the health belief model will be implemented. The training intervention will take place in four sessions in the form of lectures, questions and answers, group discussion and practical presentation. At the end of the fourth session, a training booklet will be provided on Kegel exercise, including the items taught in these 4 sessions. The purpose of this booklet is to provide guidance, increased perceived sensitivity, perceived severity, perceived benefits and self-efficacy, and reduced perceived barriers. Also, a checklist will be given to the recipients for the two months to be recorded. At the end of every two weeks, callers will be contacted and talk about the problems with the intervention.
Category
Prevention

2

Description
Control group: The control group will be selected according to the same criteria as the study group that the test group will then complete and then the questionnaire will be completed by clinical carers. Then they will be given to the control group by the clinical guards of Kegel training in the traditional way and three months later they will be asked to They will be returned to them again by clinical caregivers
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Alvand center is a city of Alborz
Full name of responsible person
دکتر مهرعلیان
Street address
فلکه پست- خیابان عمار-
City
الوند
Province
Qazvin
Postal code
36711-34319
Phone
+98 28 3224 4403
Email
k.hamzehi@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research in Qazvin University of Medical Sciences
Full name of responsible person
amir pymani
Street address
The Way of the Valley - Al-Shaheed Madani - Text of the No. 1 Research Deputy
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 7006
Email
k.hamzehi@qums.ac.ir
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 in Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
nezal AJ
Position
Faculty of Nursing and Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Bahonar Blvd.-Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
36711-34319
Phone
+98 28 3333 7006
Email
nezal_ajh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
nezal AJ
Position
Faculty of Nursing and Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Bahonar Blvd.-Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
36711-34319
Phone
+98 28 3333 7006
Email
nezal_ajh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
nezal_ajh@yahoo.com
Position
Faculty of Nursing and Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Bahonar Blvd.-Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
36711-34319
Phone
+98 28 3333 7006
Email
nezal_ajh@yahoo.com

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The spss file, the data and statistical analysis through it, as well as the final tables of the conclusions discussed in the chapters of these five theses, will be made available to this site as necessary
When the data will become available and for how long
1/5/97-1/6/97
To whom data/document is available
Medical students
Under which criteria data/document could be used
For use in research project
From where data/document is obtainable
Writer
What processes are involved for a request to access data/document
Via the valid email provided in the previous sections
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