The impact of urinary incontinence rehabilitation intervention on self esteem and quality of life in women with neurogenic bladder in Rofeideh Rehabilitation Hospital
The impact of Urinary incontinence rehabilitation Intervention on self esteem and quality of life in women with neurogenic bladder
Design
Quasi experimental study with available samples by one group method before and after with a sample size of 35 people
Settings and conduct
1) Development and approval of interventions
2) Sampling of 35 women with neurogenic bladder hospitalized in multiple sclerosis and spinal cord injuries and strokes of Rofeideh Rehabilitation Hospital
3) Explain the goals and fill out the informed and pre test consent form
4) Perform a 2 dimensional intervention including clean intermittent catheterization, behavioral therapy In 12 sessions of 30 minutes in six weeks, which are 7 sessions in the first week and then weekly
5) Post test
Participants/Inclusion and exclusion criteria
Inclusion:
Clean intermittent catheterization
Literacy
body mass index
؛
Non inclusion:
Cervical spinal cord injuries
Alcohol and drug
Acute depressive disorder
Drugs affecting urinary incontinence
Diuretics
Active urinary tract infection
Gynecological surgeries
Being pregnant
History of cesarean section or normal delivery in the last 6 months
Pelvic floor muscle prolapse
Intervention groups
1) Development and approval of interventions
2) Sampling of 35 women with neurogenic bladder hospitalized in multiple sclerosis wards and spinal cord injuries and strokes of Rofeideh Rehabilitation Hospital by available sampling method based on inclusion and exclusion criteria within a period of one month
3) Explain the goals and fill out the informed and pretest consent form
4) Perform a 2 dimensional intervention including clean intermittent catheterization, behavioral therapy (determining the time of urination, delaying urination and adjusting diet and medication) in 12 sessions in six weeks
5)Post test
Main outcome variables
Improving quality of life and self esteem in urinary incontinence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211011052729N1
Registration date:2021-12-16, 1400/09/25
Registration timing:retrospective
Last update:2021-12-16, 1400/09/25
Update count:0
Registration date
2021-12-16, 1400/09/25
Registrant information
Name
Asieh Soghrati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0066
Email address
asi.soghrati@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-03, 1399/11/15
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
2021-02-03, 1399/11/15
Actual recruitment end date
2021-03-20, 1399/12/30
Trial completion date
2021-03-20, 1399/12/30
Scientific title
The impact of urinary incontinence rehabilitation intervention on self esteem and quality of life in women with neurogenic bladder in Rofeideh Rehabilitation Hospital
Public title
The impact of urinary incontinence rehabilitation intervention on self esteem and quality of life in women with neurogenic bladder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Clean Intermittent catheterization according to the doctor's instructions
Literacy
Having a body mass index of less than 30 kg per m2
Exclusion criteria:
Cervical spinal cord injuries ( C1 to C7)
Alcohol and drugs
Acute depression
Taking medications that affect urinary incontinence or changing its prescription during the month before the study
Taking diuretics to lower blood pressure
َActive urinary tract infection according to the patient's test results
History of gynecological surgeries
Being pregnant
No history of cesarean section or normal delivery in the last 6 months
Pelvic floor muscle prolapse
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Actual sample size reached:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
Evin Blvd, Daneshjoo Ave.,Koodakyar Street, University of Social Welfare and Rehabilitation Sciences, Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2020-12-22, 1399/10/02
Ethics committee reference number
IR.USWR.REC.1399.259
Health conditions studied
1
Description of health condition studied
Urinary incontinence and neurogenic bladder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self esteem
Timepoint
Before the intervention and 6 weeks after starting the urinary incontinence rehabilitation program
Method of measurement
Rosenberg self esteem questionnaire
Secondary outcomes
1
Description
Urinary Incontinence Quality of Life Questionnaire
Timepoint
Before the intervention and 6 weeks after starting the urinary incontinence rehabilitation program
Method of measurement
Urinary Incontinence Quality of Life Questionnaire
Intervention groups
1
Description
Method of intervention: Urinary incontinence rehabilitation interventions in patients with neurogenic bladder were developed using literature review and then validated. In this way, after compiling the dimensions of urinary incontinence rehabilitation interventions in this study, using a review of the existing texts in this field, the program was compiled by 10 rehabilitation specialists, including physicians specializing in physical medicine and rehabilitation, and urologists, nutritionists. , Physiotherapist, occupational therapist and head nurses and faculty members of the nursing department with experience in rehabilitation nursing, correction, approval and accreditation. Rehabilitation intervention based on the mentioned texts and validation, including 2 dimensions of clean intermittent catheterization, behavioral therapy (determining the time of urination, delaying urination and diet and medication) in 12 sessions of 30 minutes in six weeks Which is 7 sessions in the first week and then in the second, third, fourth, fifth and sixth weeks of a week. The time of this study is from the second half of February 2021 to the end of March 2021 and the evaluation of the program in The time periods of the first week of the first session, as a pre-test (filling in the questionnaires for the first time by the clients before the intervention) and the sixth week of the twelfth session, as a post-test (filling the questionnaires for the second time by the clients after the intervention) Took. After approving the proposal and obtaining the code of ethics, sampling was done by the method available in the departments of neurology, spinal cord injury, stroke of Rofeideh Rehabilitation Hospital and was performed within a period of one month and patients with inclusion criteria were included in the study. The objectives of the study were explained to the samples and the informed consent form was completed by the patients. Neurology, spinal cord injury, stroke were completed and quality of life in urinary incontinence and self-esteem were measured before the intervention. Urinary incontinence rehabilitation interventions in a two-dimensional intervention, in 7 30-minute sessions over 1 week Individual in-person and out-of-group training due to the prevalence of Covid-19 disease was taught and at the same time an educational booklet was provided to patients. Urinary incontinence To evaluate the correct implementation of urinary incontinence rehabilitation interventions, one session was held every week. Consultation, training and follow-up of the intervention was done by telephone with the researcher. If necessary, referrals were made to medical centers. At the end of the intervention and follow-up, 6 weeks after the last training session, post-test was performed and patients again completed the research questionnaires. Educational pamphlets and urinary incontinence rehabilitation interventions were provided to hospital wards for ethics. Session 1 (Week 1): Explain the intervention and its purpose, obtaining consent from clients, pre-test, filling out questionnaires for the first time by clients / Session 2 (Week 1): Anatomy and physiology training, urinary system and how it works Session 3 (Week 1): Familiarity with neurogenic bladder and its symptoms / Session 4 (Week 1): Training of urinary incontinence rehabilitation interventions (clean intermittent catheterization) by the researcher for clients, providing all training files through the group Virtual / Session 5 (first week): Behavior therapy (setting a specific time for urination according to the urination schedule, delaying the urination time as much as possible according to the urination schedule), providing all the training files through Virtual group / Session 6 (first week): Behavior therapy (diet), providing all the training files through the virtual group / Session 7 (first week): Tracking exercises, reviewing how clients do exercises and troubleshooting By sending video and video call online, answering clients' questions / Eighth session (second week): Examining how clients do exercises And troubleshooting by sending video and video call online, answering clients 'questions / Session 9 (third week): following up on exercises, reviewing how clients perform exercises and fixing problems by sending video and video calling online, answering clients' questions / Session 10 (Week 4): Follow up the exercises, check how the exercises are done by the clients and fix the problems by sending a video and online video call, answer the questions of the clients / Session 11 (Week 5): Follow the exercises, check how to do the exercises By clients and troubleshooting by sending video and video call online, answering clients 'questions / Twelfth session (sixth week): the last session answering clients' questions, post-test, refilling questionnaires for the second time by clients, their satisfaction with the performance This intervention, feedback
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rofeideh Hospital
Full name of responsible person
Narges Arsalani
Street address
Rofeideh Hospital ,Nemati St ,Baradaran Soleimani st Gheitarieh , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1935973476
Phone
+98 21 23570
Email
rofeideh.hospital@uswr.ac.ir
Web page address
https://rofeideh.uswr.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr Hamidreza khoram khorshid
Street address
Evin Blvd, Daneshjoo Ave.,Koodakyar Street, University of Social Welfare and Rehabilitation Sciences, Tehran- Iran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
pr@uswr.ac.ir
Web page address
https://uswr.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
nothing
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Narges Arsalani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Evin Blvd, Daneshjoo Ave.,Koodakyar Street, University of Social Welfare and Rehabilitation Sciences, Tehran- Iran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
nargesarsalani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Narges Arsalani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Evin Blvd, Daneshjoo Ave.,Koodakyar Street, University of Social Welfare and Rehabilitation Sciences, Tehran- Iran
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۷۱
Phone
009822180083
Email
nargesarsalani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Asieh Soghrati
Position
MSC of Rehabilitation Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Evin Blvd, Daneshjoo Ave.,Koodakyar Street, University of Social Welfare and Rehabilitation Sciences, Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
asi.soghrati@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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Academic people and scientific institutions
Under which criteria data/document could be used
Ethical, legal and scientific licenses
From where data/document is obtainable
Referred to the University of Social Welfare and Rehabilitation Sciences, Department of Nursing, Associate Professor of Nursing Dr. Narges Arsalani (Corresponding Author)
Or send an email to the address
nargesarsalani@gmail.com
What processes are involved for a request to access data/document
Ethical, legal and scientific licenses of university
Going to university of social welfare and rehabilitation sciences