Determining the effect of group counseling based on Pender model of health promotion on quality of life of women with stress urinary incontinence
Design
A clinical trial with a control group, in parallel groups, will be performed on 70 patients who are selected by the available method and then randomly assigned to the control and intervention groups.
Settings and conduct
Sampling will be done in gynecological clinics in Mashhad. Women in both control and intervention groups complete the quality of life questionnaire of patients with urinary incontinence and a researcher-made questionnaire based on Pender model constructs as a pre-test. Then, women in the intervention group will receive 6 sessions of group counseling based on Pender's health promotion model structures for 45 to 60 minutes. The collected data will be analyzed with SPSS software version 25.
Participants/Inclusion and exclusion criteria
Have informed consent to participate in research.
Be Iranian.
Be over 18 years old.
Be at least literate.
Have a smartphone to call and follow up to participate in the study.
not pregnant.
Do not have any known disease related to urinary incontinence.
Do not use drugs and diuretics.
Do not use tobacco, drugs and alcohol.
has no movement restrictions.
Be able to communicate verbally.
Have BMI less than 30.
Do not have urinary tract infection.
Having stress urinary incontinence
Do not have severe stress and anxiety
Do not attend more than one consultation session
Reluctance to continue cooperation in research.
Have an unfortunate accident during the research.
Intervention groups
Women with stress urinary incontinence in the intervention group will receive 6 sessions of counseling at one-week intervals. The control group will receive only routine care, including specialist visits, among those with stress urinary incontinence.
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211216053423N1
Registration date:2022-03-14, 1400/12/23
Registration timing:prospective
Last update:2022-03-14, 1400/12/23
Update count:0
Registration date
2022-03-14, 1400/12/23
Registrant information
Name
Mahtab Mahvashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
mahvashim982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-07-22, 1401/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group counseling based on Pender's health promotion model on quality of life in women with stress urinary incontinence
Public title
The effect of group counseling based on Pender model on quality of life in women with stress urinary incontinence
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have informed consent to participate in research.
Be Iranian.
Be over 18 years old.
Be at least literate.
Have a smartphone to call and follow up to participate in the study.
not pregnant.
Do not have any known disease related to urinary incontinence.
Do not use drugs and diuretics.
Do not use tobacco, drugs and alcohol.
has no movement restrictions.
Be able to communicate verbally.
Have BMI less than 30.
Do not have urinary tract infection.
Having stress urinary incontinence based on getting a score of 4 and above from the first three questions of the QUID questionnaire.
Do not have severe stress and anxiety (according to the DASS 21 Stress, Anxiety and Depression Questionnaire)
Exclusion criteria:
Not participating in counseling sessions for more than one session and not wanting to continue the intervention.
Reluctance to continue cooperation in research.
Have an unfortunate accident during the research.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, permutation block method was used to generate a sequence of random allocation of individuals to the study groups. Assignment sequence
Randomization of individuals was performed using random allocation software and block size two. The permutation block method is one of
Random allocation methods in which each block is selected according to the number of groups studied. In this study two blocks AB And there is a BA. One of the blocks is selected at random. If the first block, AB, is selected, the first person goes to group A and the second person goes to group B is assigned. And this process continues until all the samples are assigned. The characteristic of this method is that the two study groups will have equal numbers .
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 Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery, Ibn Sina St, Doctra Crossroads, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2022-02-22, 1400/12/03
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.092
Health conditions studied
1
Description of health condition studied
Stress urinary incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence (female) (male)
Primary outcomes
1
Description
Quality of Life
Timepoint
Before the intervention, immediately after the intervention, 2 months after the intervention
Method of measurement
Standard Questionnaire for Quality of Life in People with Urinary Incontinence
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After obtaining written consent from the selected individuals and completing the sample selection form and confirming the absence of urinary tract infection after a negative urine test, the type of urinary incontinence will be determined by the Urinary Incontinence Diagnosis Questionnaire (QUID). Eligible individuals are then assigned to the control and intervention groups as permutation blocks. In each group, a demographic and pre-test questionnaire is completed. The pre-test includes completing the Quality of Life Questionnaire for People with Urinary Incontinence (IQOL), the DASS Stress and Anxiety Questionnaire, and a researcher-made questionnaire based on Pender model constructs. The standard quality of life questionnaire examines the quality of life of people with urinary incontinence in three areas of avoidance behaviors, psychosocial domain and social embarrassment. The questionnaire is scored from zero to 100. A higher score indicates a better quality of life. It is worth mentioning that the validity and reliability of the Persian version of the Quality of Life Questionnaire in Astronomical Study et al(2009) has been confirmed. Another questionnaire used in this study is the QUID. This questionnaire contains 6 questions. Validity and reliability of this questionnaire has been done by Mokhlesi et al (2015). People who get a score of 4 or higher from this questionnaire will enter the research. In both intervention and control groups, after providing the necessary explanations about the objectives of the research, the independence of individuals to participate in the research and the confidentiality of information, participants are asked to complete the form of informed consent. Each day, the quality of life, the DASS stress and anxiety questionnaire, and the questionnaire based on Pender model constructs will be completed. Patients with stress incontinence stress in the intervention group participate in 6 group counseling sessions that will be held by the researcher every week in gynecological clinics. Each session will be held for 45 to 60 minutes. Counseling sessions will be held in groups of 4 to 5 women, women in the same group in the first counseling session, in the next sessions will be in the same group. Considered for quiet and private environmental counseling and counseling based on the Pender model. Counseling sessions will be held in full compliance with health protocols and maintaining safe conditions for women. In the last session, quality of life questionnaire and questionnaire based on Pender model constructs will be completed. Also, two months after the intervention, the two questionnaires will be completed by research units. Routine care control group received a specialist visit. will do. The content of the consultation sessions will be scheduled based on the Pender model structures in each session.
Category
Lifestyle
2
Description
Control group: After obtaining written consent and completing the sample selection form and confirming the absence of urinary tract infection, the type of urinary incontinence will be determined by the Urinary Incontinence Diagnosis Questionnaire (QUID). Eligible individuals are then assigned to the control and intervention groups by permutation blocks. People in this group, the control group, will receive routine care, including a specialist visit, and will complete research-related questionnaires completed in the intervention group, but will not hold any counseling sessions for these individuals.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Educational, Research and Treatment Center
Full name of responsible person
Dr. Marjaneh Farazestanian
Street address
Ahmad Abad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2299
Email
b.qhaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
School of Nursing and Midwifery, Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
mahvashim982@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Mahtab Mahvashi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina St, Doctra Crossroads, Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
mahvashim982@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kobra Mirzakhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina St, Doctra Crossroads, Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
mirzakhanik@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahtab Mahvashi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina St, Doctra Crossroads, Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
mahvashim982@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
All data can be shared after unidentified individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published.
To whom data/document is available
Researchers and students of academic institutions
Under which criteria data/document could be used
With citing to the current study and with out any change in the data
From where data/document is obtainable
Contact the author responsible for responding via email or phone:
mahvashim982@mums.ac.ir 09301530307
What processes are involved for a request to access data/document
The requests for access to data and documents will be reviewed by the research team.