Determining the effectiveness of life skills training with a psychodrama approach on sexual self-concept in women with vaginismus
Design
Clinical trial without control group, only and without blinding, randomized on 3 patients
Settings and conduct
Screening to find samples is done in sexual disorders treatment clinics and private offices in Ahvaz city, and counseling is done by the researcher at Binish Counseling Center in Ahvaz city.To implement the treatment method, the first person enters the treatment plan, and at each stage of the baseline, the research tool (The multidimensional sexual self concept Questionnaire, ) is implemented on the first person. The first person is measured twice, the second person three times, the third person four times.Measurements are done weekly by completing the research tool. Then the treatment is carried out by the researcher for 8 weekly sessions of 90 minutes.
Participants/Inclusion and exclusion criteria
The inclusion criteria for the study include: age 18-45 years - cycle education - confirmation of vaginismus by a psychiatrist
Intervention groups
The intervention group will receive cognitive behavioral therapy in the form of 8 sessions of 90 minutes and once a week based on the package "Sexual cognitive behavioral therapy in vaginismus".
Main outcome variables
changing false beliefs; Creating a positive sexual self-concept; Improving life skills
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220713055457N4
Registration date:2022-11-20, 1401/08/29
Registration timing:retrospective
Last update:2022-11-20, 1401/08/29
Update count:0
Registration date
2022-11-20, 1401/08/29
Registrant information
Name
Zohreh Ahmady
Name of organization / entity
Islamic Azad Univercity Behbahan Branch
Country
Iran (Islamic Republic of)
Phone
+98 916 982 5673
Email address
zohreh.ahmady@iau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-08, 1401/08/17
Expected recruitment end date
2022-11-16, 1401/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of life skills training with a psychodrama approach on sexual self-concept in women with vaginismus
Public title
The effectiveness of life skills training with a psychodrama approach on sexual self-concept in women with vaginismus
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-45 years old
cycle education
Vaginismus is confirmed by a psychiatrist
Exclusion criteria:
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
3
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
Ethics committee of Islamic Azad University Behbahan Branch
Street address
Shahid Bayani Ave.,AmirKabir Blvd.,Behbahan City
City
Behbahan
Province
Khouzestan
Postal code
6361713198
Approval date
2022-09-19, 1401/06/28
Ethics committee reference number
IR.IAU.BEHBAHAN.REC.1401.017
Health conditions studied
1
Description of health condition studied
Vaginismus
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Positive sexual self-concept
Timepoint
Before the study, session 2-4-6, immediately and 2 months after the treatment
Method of measurement
The multidimensional sexual self concept Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cognitive behavioral therapy is carried out in 8 sessions of 90 minutes and once a week based on the package "Sexual cognitive behavioral therapy in vaginismus". The educational content of the sessions includes: getting to know the anatomy of the body, getting to know the sex cycle, courage, education Communication skills and problem solving, sensory focus type one and two, recognizing irrational beliefs and thoughts, cognitive restructuring and changing negative attitudes towards sexual issues, cognitive skills training،Dealing with negative emotions and teaching Kegel exercises.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Bibesh Counseling center
Full name of responsible person
Lila Jazayeri
Street address
No. 20,West 7th Street,Kianpars Blvd
City
Ahvaz
Province
Khouzestan
Postal code
8765489975
Phone
+98 916 982 5673
Email
zohrehahmady2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
SHahrooei
Street address
Shahid Bayani Ave.,AmirKabir Blvd.,Behbahan City
City
Behbahan
Province
Khouzestan
Postal code
6361713198
Phone
+98 61 5287 0109
Email
info@behu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad 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
Islamic Azad University
Full name of responsible person
Arezoo Rezaei
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No.5 ; Parvin Ave
City
Esfahan
Province
Isfehan
Postal code
9876547986
Phone
+98 913 125 4332
Email
a.rezaei@behiau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arezoo Rezaei
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No.5 ; Parvin Ave
City
Esfahan
Province
Isfehan
Postal code
98765438865
Phone
+98 913 125 4332
Email
a.rezaei@behiau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arezoo Rezaei
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No.5 ; Parvin Ave
City
Esfahan
Province
Isfehan
Postal code
98753478869
Phone
+98 913 125 4332
Email
a.rezaei@behiau.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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