The purpose of this study is the effectiveness of cognitive behavioral therapy on sexual shyness, sexual daring and sexual performance in women with vaginismus.
Design
Semi-experimental study with multiple baseline method, without control group, without blinding, randomly 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 tools( Female Sexual Function Index- Hullbert Index of Sexual Desire- Sexual Self-Consciousness Index) are 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 tools. Then the treatment is carried out by the researcher for 8 weekly sessions of 90 minutes. All questionnaires are completed in sessions 4, 2, 6 and immediately after the treatment. In order to follow up, people are re-evaluated two months after the treatment in three twenty-day sessions.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include: age 18-45 years old - cycle education - confirmation of vaginismus by a psychiatrist, and the exclusion criteria include having a mental illness.
Intervention groups
Cognitive behavioral therapy is performed as 8 sessions of 90 minutes and once a week based on the package "Sexual cognitive behavioral therapy in vaginismus".
Main outcome variables
sexual shyness, sexual daring and sexual performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220713055457N1
Registration date:2022-11-02, 1401/08/11
Registration timing:prospective
Last update:2022-11-02, 1401/08/11
Update count:0
Registration date
2022-11-02, 1401/08/11
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
2022-11-06, 1401/08/15
Expected recruitment end date
2022-11-13, 1401/08/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive behavioral therapy on sexual shyness, sexual daring and sexual performance in women with vaginismus
Public title
The effectiveness of cognitive behavioral therapy on sexual shyness, sexual daring and sexual performance in women with vaginismus
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-45 years
Confirmation of vaginismus by a psychiatrist
Cycle education
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.1401.019
Health conditions studied
1
Description of health condition studied
vaginismus
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
sexual performance in women with vaginismus
Timepoint
Examination of sexual performance before the study - sessions 4, 2, 6, immediately after completion of treatment and two months after treatment
Method of measurement
Female Sexual Function Index- Hullbert Index of Sexual Desire- Sexual Self-Consciousness Index
2
Description
sexual shyness in women with vaginismus
Timepoint
Examination of sexual shyness before the study - sessions 4, 2, 6, immediately after completion of treatment and two months after treatment
Method of measurement
Female Sexual Function Index- Hullbert Index of Sexual Desire- Sexual Self-Consciousness Index
3
Description
sexual daring in women with vaginismus
Timepoint
Examination of sexual daring before the study - sessions 4, 2, 6, immediately after completion of treatment and two months after treatment
Method of measurement
Female Sexual Function Index- Hullbert Index of Sexual Desire- Sexual Self-Consciousness Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: consists of 3 women. cognitive behavioral therapy is performed by the researcher for 8 weekly sessions of 90 minutes.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Binesh Consulting Center
Full name of responsible person
Leyla Jazayeri
Street address
No. 20,West 7th Street,Kianpars Blvd
City
Ahvaz
Province
Khouzestan
Postal code
1326790758
Phone
+98 916 844 8839
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 0105
Email
zohrehahmady2@gmail.com
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
Zohreh Ahmady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No25,Sepah1 Ave,Chahar shir Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6165664573
Phone
+98 916 982 5673
Email
Zohreh.Ahmady@iau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zohreh Ahmady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No25,Sepah1 Ave,Chahar shir Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6165664573
Phone
+98 916 982 5673
Email
Zohreh.Ahmady@iau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
ZohrehAhmady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No25,Sepah1 Ave,Chahar shir Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6165664573
Phone
+98 916 982 5673
Email
Zohreh.Ahmady@iau.ac.ir
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
There is no further information
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