The effect of education based on continuous care model on quality of life and self-efficacy in women with urinary incontinence treated by pelvic floor muscle training.
The effect of education based on continuous care model on quality of life and self-efficacy in women with urinary incontinence treated by pelvic floor muscle training.
Design
Randomized trial with control group, don't blinded, with parallel groups and easy sampling.
Settings and conduct
The research environment are: Imam Khomeini Hospital and Arash Hospital affiliated to Tehran University of Medical Sciences. Convenient sampling method will be used.women who are eligible for the study, will be invited to collaborate and informed consent will be obtained. Data collection toolsare consist of three questionnaires: Individual-Midwifery Questionnaire, Urinal Incontinence Quality of Life Questionnaire (IQOL), and Broome self-efficacy questionnaire, will be completed by all participants in the two groups of control and intervention. And four steps of continuous care model will be performed for intervention group for 8 weeks. At the end of the follow-up period, IQOL and Broom questionnairs will be completed by all participants in the two groups of control and intervention and The results of the two groups will be compared and finalized.
Participants/Inclusion and exclusion criteria
Iranian married women with at least 20 years old and don't pregnant, Don't have UTI (Urinary Tract Incontinence), Don't use drugs for treatment of UTI.
Intervention groups
In order to avoid exposing the intervention and control groups, women referred to Imam Khomeini Hospital in the experimental group and women referred to Arash Hospital will be in the control group and the four stages of the follow-up continuous care model will be performed for the test group.
Main outcome variables
1-Quality of life
2-Self-efficacy
3-Urinary incontinence
4-Conitnuous care model
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160821029446N3
Registration date:2018-05-14, 1397/02/24
Registration timing:registered_while_recruiting
Last update:2018-05-14, 1397/02/24
Update count:0
Registration date
2018-05-14, 1397/02/24
Registrant information
Name
Maryam Damghanian
Name of organization / entity
Nursing and Midwifery Faculty, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
m-damghanian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on continuous care model on quality of life and self-efficacy in women with urinary incontinence treated by pelvic floor muscle training.
Public title
The effect of continuous care model on quality of life and self-efficacy in women with urinary incontinence.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality
Married
At least 20 years old and older
Don't have UTI (urinary tract infection)
Don't being pregnant or after pregnancy period
Being educated
Don't use drugs for treatment of UTI
There is no injured urinary tract
The diagnosis of UI have been done by a specialist
Exclusion criteria:
Age
From 20 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the intervention group, which includes women with urinary incontinence treated by pelvic floor muscle training in Imam Khomeini Hospital, is trained based on continuous care model . While the control group, which includes women with urinary incontinence treated by pelvic floor muscle training in Arash Hospital, do not receive any more intervention. For them, the questionnaires will be completed at the beginning of the study and 8 weeks later.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Nursing and Midwifery and Rehabilitation Faculty of Tehran University of Medica
Street address
Nursing and Midwifery and Rehabilitation Faculty of Tehran University of Medical Sciences, Tohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-01-21, 1396/11/01
Ethics committee reference number
IR.TUMS.FNM.REC.1396.4296
Health conditions studied
1
Description of health condition studied
Urinary Incontinence
ICD-10 code
N39.41
ICD-10 code description
Urge incontinence
2
Description of health condition studied
Urinary Incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence (female)
Primary outcomes
1
Description
Quality of life
Timepoint
At the beginning of the study, after the end of the intervention
Method of measurement
IQOL quality of life questionnaire
2
Description
Self-efficacy
Timepoint
At the beginning of the study, after the end of the intervention.
Method of measurement
Broom questionnaire
3
Description
Urinary incontinence
Timepoint
At the beginning of the study, after the end of the intervention.
Method of measurement
Diagnose of the specialist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: With the aim of the effect of education based on continuous care model on quality of life and self-efficacy in women with urinary incontinence treated by pelvic floor muscle training, 3 to 4 education sessions lasting 60 to 40 minutes will be held based on continuous care model with a educational booklet. After that, for eight weeks, the researcher will contact the patients by telephone and SMS for monitoring the treatment process.
Category
Behavior
2
Description
Control group: The control group, which includes women with urinary incontinence treated by pelvic floor muscle training in Arash Hospital, do not receive any more intervention. For them, the questionnaires will be completed at the beginning of the study and 8 weeks later.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeyni Hospital
Full name of responsible person
Maryam Damghanian
Street address
School of Nursing & Midwifery, East Nosrat Ave, Towhid Square.Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4222
Email
maryam_damghanian@yahoo.com
2
Recruitment center
Name of recruitment center
Arash Hospital
Full name of responsible person
Maryam Damghanian
Street address
School of Nursing & Midwifery, East Nosrat Ave, Towhid Square.Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4222
Email
maryam_damghanian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Esmat Karimi
Street address
Number 23, Dameshgh Street, Valiasr Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4222
Email
maryam_damghanian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Faezeh Aliakbari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, East Nosrat Ave, Towhid Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 7722 0564
Email
faezehaliakbari70@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, East Nosrat Ave, Towhid Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4222
Email
maryam_damghanian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, East Nosrat Ave, Towhid Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4222
Email
maryam_damghanian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD