Determining the effect of improving sexual function by counseling with CBT in women with vaginismus
Design
-an intervention study, randomized-blinded clinical trial in a parallel way.
30 people with vaginismus criteria who will be divided into two groups by simple randomization method. 15people will receive routine treatments for vaginismus (sexual counseling with CBT) (control group) and 15 people will receive interventional treatments (sexual counseling with CBT and Kegel).
In a study conducted by Cansu Işık, the effect size was determined to be around 1.6. Therefore, according to the values mentioned below, the sample size was calculated to be 10 people in each intervention and control group. Due to the possible loss of samples, 15 patients in each group will enter the treatment process.
Settings and conduct
People will be divided into A,Bgroups and then the link to complete the questionnaire will be provided to them online. The method of blinding is also such that group A and group B, since they are members of two separate telegram groups, none of them knows about the treatments of the other group.
Participants/Inclusion and exclusion criteria
inclusion criteria:19-45 years old,healthy genital organ,Having a spouse or life partner for at least 6months,Having a diagnosis of primary vaginismus
Intervention groups
30 people with vaginismus criteria will be divided into 2groups(A,B) by simple randomization method.15people will receive routine treatment of vaginismus (sexual counseling with CBT) (control group) and 15 people will receive interventional treatments (sexual counseling with CBT and Kegel).
Main outcome variables
Treatment of vaginismus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190607043832N1
Registration date:2024-10-30, 1403/08/09
Registration timing:registered_while_recruiting
Last update:2024-10-30, 1403/08/09
Update count:0
Registration date
2024-10-30, 1403/08/09
Registrant information
Name
Masoudeh Babakhanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3328 5659
Email address
babakhanian.m@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of counseling with Cognitive Behavioral treatment(CBT) and Kegel exercises on sexual functions in women with vaginismus
Public title
effects of counseling with Cognitive Behavioral treatment(CBT) and Kegel exercises on sexual functions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
19 and 45 years old.
Having healthy genitals
diagnosed with primary vaginismus,
Spouse or partner for at least six months
Exclusion criteria:
Having severe forms of sexual dysfunction or severe mental disorders with a psychiatric diagnosis
Having serious problems in marriage/relationship
Age
From 19 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
after announcing the objectives of the study and obtaining informed consent, In a randomized controlled trial, participants in the trial are randomly divided into at least two groups: the first group, which is treated with the experimental treatment, and the second group, the control group, which is used for comparisonو people will be divided into two groups, A and B, using the random number table using the random allocation method (in the range of numbers one to thirty of this table).
Blinding (investigator's opinion)
Single blinded
Blinding description
The method of blinding is also such that group A and group B, since they are members of two separate telegram groups, none of them knows about the treatments of the other group. Here, the control group consists of participants who receive only the reference treatment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Basij Blvd
City
سمنان
Province
Semnan
Postal code
35147-99442
Approval date
2024-05-13, 1403/02/24
Ethics committee reference number
IR.SEMUMS.REC.1403.040
Health conditions studied
1
Description of health condition studied
vaginismus
ICD-10 code
N94.2
ICD-10 code description
Vaginismus
Primary outcomes
1
Description
Vaginismus disorder score
Timepoint
Immediately before the treatment, at the end of the fourth week and the end of the second month
Method of measurement
vaginal penetration cognition questionnaire (VPCQ) AND Female Sexual Function Index-FSFI
Secondary outcomes
1
Description
Sexual satisfaction
Timepoint
Before treatment, at the end of the fourth week and the third month
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Group A = intervention group (receiving sexual counseling with cognitive-behavioral therapy technique + Kegel exercises). This treatment will be done during 5 sessions and 45 minutes each time in a group therapy process. The content of the sessions includes getting to know your body, encouraging exercise, self-soothing exercises, pelvic floor exercises, controlling negative thoughts, the ability to use dilators, and finally having sex with your partner.
Category
Behavior
2
Description
Control group: Group B = control group during 5 sessions (getting to know your body, doing Kegel exercises, encouraging to do exercises, using dilators, having a relationship with your sexual partner).:
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Fateme Azartash Counseling Center
Full name of responsible person
Dr. Fateme Azartash
Street address
No. 55, 2nd floor, Unit 2, No. 55, corner of East 38th Street, South Allameh St., Saadat Abad, Management Bridge
City
Tehran
Province
Tehran
Postal code
1985853731
Phone
+98 21 8858 3308
Email
azartash_fatemeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Basij Blvd
City
semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3345 1336
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Masoudeh Babakhanian
Position
employee
Latest degree
Ph.D.
Other areas of specialty/work
Social Services
Street address
Velayet Hospital
City
Damghan
Province
Semnan
Postal code
3671637881
Phone
+98 23 3522 5125
Email
babakhanian.m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Masoudeh Babakhanian
Position
employee
Latest degree
Ph.D.
Other areas of specialty/work
Social Services
Street address
Velayat hospital
City
Damghan
Province
Semnan
Postal code
3671637881
Phone
+98 23 3522 5125
Email
babakhanian.m@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Masoudeh Babakhanian
Position
employee
Latest degree
Ph.D.
Other areas of specialty/work
Social Services
Street address
Velayat hospital
City
Damghan
Province
Semnan
Postal code
3671637881
Phone
+98 23 3522 5125
Email
babakhanian.m@gmail.com
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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
Beginning of the access period from 2025
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For use in secondary studies such as systematic review studies and meta-analysis
From where data/document is obtainable
Email:
babakhanian.m@gmail.com
What processes are involved for a request to access data/document
A person can receive data after introducing herself/herself, the project she is studying, her academic degree and the institution she works in the form of an email