The purpose of this semi experimental intervention study is empowering women with stress incontinence in improving quality of life. period of intervention is 1 months, 64 women are randomly divided to the intervention and control groups. The study begins with conducting pretest. The control group do not receive any intervention. The intervention is training sessions based on family-centered empowerment model steps: 1- Increasing the perceived threat (sensitivity and perceived severity of the problem in the test group increase in two 45-minute sessions of group discussion) 2- Problem solving (women become practically familiar with the problem and its solving process during two 45-minute sessions of group discussion ) 3- Education Partnership (educational materials in the form of pamphlet is transferred through the women to the active family member) 4- Process evaluation are done with oral questions at the beginning and after the end of each session and final evaluation are conducted with post-test. Inclusion criteria: Having stress incontinence grade 1 and 2 Vaginal prolapse examination and no need for surgical for correction of stress urinary incontinence; Having 60-20 years of age; At least read and write; Family members tend to participate in the intervention; Not pregnant; Not having mental illness such as depression; disability; spinal cord injury and MS; After one year of delivery Exclusion criteria: The presence of irregular and ineffective in educational sessions; Become pregnant during the program; Physical injury during the program. Outcomes include increased quality of life through women's empowerment in improvement of urinary incontinence by reducing complications and related diseases
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013041913064N1
Registration date:2013-07-22, 1392/04/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-22, 1392/04/31
Registrant information
Name
Nadia Kolbadinezhad
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 3028
Email address
kolbadinezhad.n@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Gonabad University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of application of family- centered empowerment model on the quality of life of women suffering from stress urinary incontinence.
Public title
Effect of application of family- centered empowerment model on the quality of life of women suffering from stress urinary incontinence.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having stress incontinence grade 1 and 2 Vaginal prolapse examination and no need for surgical for correction of stress urinary incontinence; Having 60-20 years of age; At least read and write; Family members tend to participate in the intervention; Not pregnant; Not having mental illness such as depression; disability; spinal cord injury and MS; After one year of delivery
Exclusion criteria:
The presence of irregular and ineffective in educational sessions; Become pregnant during the program; Physical injury during the program.
Age
From 20 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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 Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi
City
Gonabad
Postal code
9691793718
Approval date
2013-05-28, 1392/03/07
Ethics committee reference number
3/1/92/ک الف
Health conditions studied
1
Description of health condition studied
Stress Urinary Incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress Incontinence
Primary outcomes
1
Description
Quality Of Life
Timepoint
before and 6 weeks after intervention
Method of measurement
IQOL Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Education based on family centered empowerment model steps will be implemented as following: Step one: The first step in family centered empowerment model is, increasing the perceived threat (perceived severity and perceived susceptibility) in the test group. Thus, by holding two group discussions and question and answer of participants in the field of knowledge and awareness associated with stress urinary incontinence and will lead to complications and problems, we will try to improve the perceived threat (severity and perceived susceptibility). The second step in the empowerment model of family-centered, is problem solving: Problem solving will be conducted via group discussions. The goal of this step is, understanding the problem by women and providing its solution. Hence problem-solving sessions, will hold in two 45-minute group discussions in small group of women, with together, under supervision of the researcher, with an objective example of their situation and expressing their experiences and also will discuss in what they have done so far in order to modify their treat of disease and so at this stage, women get practically familiar with their problems and their solving process and this issue will enhance their efficacy. The third step in the family-centered empowerment model, is participation in training: in this step, discussed topics in previous meetings, on educational participation, transferred by the pamphlets to the active member of the family, by women, in order to participate and support of their. The fourth step in family centered empowerment model is evaluation that includes two stages: process evaluation and final evaluation.
Category
Behavior
2
Description
The control group do not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Gonabad city Health Centers
Full name of responsible person
Nadia Kolbadinezhad
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Gonabad University of Medical Sciences
Full name of responsible person
Shahla Khosravan
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi
City
Gonabad
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 Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Nadia Kolbadinezhad
Position
MSc. Student in Commiunity Health Nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi