Determining the effect of cognitive-behavioral therapy on sexual self-esteem and sexual function in women of reproductive age with urinary incontinence
Design
This study is a Randomized clinical trial. The number of sample members is estimated at 84.Sampling will be performed by sequential non-probability method. Sample members will be divided into intervention (n = 42) and control (n = 42) groups. Assignment of individuals to each group will be done by random block method (6 blocks)
Settings and conduct
Research location: Dezful health centers.The short form of the ICIQ-SF questionnaire will be given to women who are eligible to enter the study, and, people who score equal to or higher than 1 will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Married women 2. reproductive ages (15-45 years) 3. Literate (diploma education) 4. Resident in Dezful 5. Age gap less than 10 years from the spouse. Exclusion criteria: 1. No history of serious physical or mental illness (such as psychotic disorders; schizophrenia or major depression,....) 2. Occurrence of diseases affecting the sexual function of a woman or her husband (such as: cardiovascular disease, psychiatric thyroid, ...) 3. Participate in sex education classes 4. Taking medication to improve sexual function
Intervention groups
People in the intervention group will receive 8 sessions (for 45 minutes) of face-to-face cognitive-behavioral therapy, While the control group will not receive any intervention except of routine care.
Main outcome variables
Sexual function and sexual self-esteem of women of childbearing age with urinary incontinence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210516051312N1
Registration date:2021-05-19, 1400/02/29
Registration timing:prospective
Last update:2021-05-19, 1400/02/29
Update count:0
Registration date
2021-05-19, 1400/02/29
Registrant information
Name
Salimeh Moradinasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4242 8477
Email address
moradi.sal@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive behavioral therapy on sexual self-esteem and sexual function in women of reproductive age with urinary incontinence
Public title
The effect of cognitive behavioral therapy on sexual self-esteem and sexual function in women of reproductive age with urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women
Reproductive ages (15-45 years)
afflicted to urinary incontinence
Literate (diploma education)
Resident in Dezful
Age gap less than 10 years with spouse
Exclusion criteria:
No history of serious physical or mental illness (such as psychotic disorders; schizophrenia or major depression, need special diet or medication)
Occurrence of diseases that affect the sexual function of a woman or her husband (such as: cardiovascular disease, psychiatric thyroid, cancer
Participate in sex education classes
Taking medication to improve sexual function
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of individuals to each of the treatment groups will be done by randomly blocking method and using 6 blocks (7 groups of 6 people).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd, Ahwaz
City
ahwaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2021-05-16, 1400/02/26
Ethics committee reference number
IR.AJUMS.REC.1400.102
Health conditions studied
1
Description of health condition studied
urinary incontinence
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual function in women of childbearing age afflicted to urinary incontinence
Timepoint
Before the intervention - at the end of the intervention - 1 month after the intervention
Method of measurement
Sexual Function Questionnaire in People with Urinary Incontinence (PISQ-12)
2
Description
Sexual self-esteem of women of childbearing age afflicted to urinary incontinence
Timepoint
Before the intervention - at the end of the intervention - 1 month after the intervention
Method of measurement
Sexual Self-Esteem Questionnaire (SSEI-W -SF)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 8 sessions of cognitive-behavioral therapy, once a week (each session: 45 minutes)
Category
Behavior
2
Description
Control group : Except of routine care, no intervention is performed in the control group. After the intervention, they will receive training based on cognitive-behavioral therapy
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
health centers of Dezful
Full name of responsible person
Salimeh Moradinasab
Street address
No. 10, Golestan st, vahed Ave, Dezful
City
Dezful
Province
Khouzestan
Postal code
۶۴۶۱۶-۵۷۵۱۴
Phone
+98 61 4242 8477
Email
Salimeh268@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Ahwaz Jundishapur University
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Golestan Blvd, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
ahmadi-m@ajums.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 and Technology, Ahwaz Jundishapur University
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
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Position
Associate Professor of Reproductive Health Department of Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Golestan Blvd, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8395
Email
minairavani2004@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Position
Associate Professor of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Golestan Blvd, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8395
Email
minairavani2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Salimeh Moradinasab
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 10, Vahed Ave, Golestan st, Dezful Town
City
Dezful
Province
Khouzestan
Postal code
64616-57514
Phone
+98 61 4242 8477
Email
Salimeh268@gmail.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