Purpose: This study have been designed to evaluate the effect of Cognitive Behavioral Sex Therapy for Vaginismus on decreasing anxiety and increasing sexual function in patients with vaginismus.
Method: Statistical population included all married women aged 20-35 years old with vaginismus. That referred to Farhangian Shahid Abuzari and Vali-Asr therapeutic centers in Shahr-e-Ray city. According to inclusion criteria, thirty women with vaginismus were selected as study sample and randomly assigned to two control and experimental groups. Research design was pretest-posttest with a control group. The experimental groups were trained in cognitive behavioral sex therapy for vaginismus during twelve sessions, on hour in each week. The Female Sexual Function Index (2000) and State-Trait Anxiety Inventory (1983) were used as instruments of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031027004N1
Registration date:2016-11-29, 1395/09/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-29, 1395/09/09
Registrant information
Name
Mahnaz Aliakbari Dehkordi
Name of organization / entity
Payame Noor University
Country
Iran (Islamic Republic of)
Phone
+98 21 2249 1259
Email address
m_akbari@pnu.ac.ir
Recruitment status
Recruitment complete
Funding source
Payame Noor University
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of Cognitive Behavioral Sex Therapy for Vaginismus (CBST-V) on decreasing anxiety and increasing sexual function
Public title
The therapeutic and educational package for sexual disorders of women
Purpose
Treatment
Inclusion/Exclusion criteria
Criteria for inclusion: age between 20-35 years old; Diagnosis of vaginismus by a gynecologist.
Criteria for exclusion: having female sexual problems and severe inflammatory diseases of genital system; Severe psychological disorders
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
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
Mazandaran University of Medical Sciences
Street address
Sari, Imam Square
City
Sari
Postal code
Approval date
2016-10-19, 1395/07/28
Ethics committee reference number
IR.MAZUMS.REC.95.S173
Health conditions studied
1
Description of health condition studied
Vaginismus
ICD-10 code
N94.2
ICD-10 code description
Spasm of the pelvic floor muscles that surround the vagina, causing occlusion of the vaginal opening. Penile entry is either impossible or painful.
Primary outcomes
1
Description
anxiety
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Questionnaires of The State-Trait Anxiety Inventory (Spielberger, 1983)
2
Description
Sexual Function
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Female Sexual Function Index (Rosen et al, 2000)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This therapeutic package has been made based on the cultural-related features and the differences which exist among Iranian women as compared with Western women. Its underlying principles were taken from the instructions of Ter Kuile et al. (2007), Their study was done on patients with vaginismus. Therefore, additional cases was necessary that were reviewed and approved by a number of psychologists and gynecologists. This training designed for twelve weeks, a one-hour session in each week. A summary of the Cognitive Behavioral Sex Therapy for Vaginismus package was as follows: 1)Becoming familiar with the female sexual disorders and cognitive-behavioral therapy, 2) Defining normal sexual orientation and physiological responses and describing male and female’s sexual cycles, 3)Muscle relaxation training, 4)Effective communication training, 5)Problem solving, self-confidence reinforcement and anger management skills training, 6) Cognitive restructuring in relation to sexual-mental disorders, 8) Improving sexual techniques and skills (sensory focus 1), 9) Improving sexual techniques and skills (sensory focus 2), 10,11,12) Regular desensitization for sexual penetration. Each of the main topics of this educational package was instructed in one or two sessions and in all sessions some assignment were given to participants. This educational package is not only usable for women with vaginismus and other sexual problems, but also its instructions can be used for all women who want to improve their sexual functioning, even if they do not have any sexual problems.
Category
Behavior
2
Description
For the control group, no intervention was done. In case of proving the hypotheses, this treatment will be taught the control group for free.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Farhangian Shahid Abuzari Therapeutic center
Full name of responsible person
A'zam Mohammadi
Street address
City
Shahr-e-Ray
2
Recruitment center
Name of recruitment center
Vali-Asr Therapeutic Center
Full name of responsible person
A'zam Mohammadi
Street address
City
Shahr-e-Ray
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Payame Noor University
Full name of responsible person
Mahnaz Aliakbari Dehkordi
Street address
Nejatollahi st., Enghelab Avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Payame Noor University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
A'zam Mohammadi
Position
Psychology, MSc
Other areas of specialty/work
Street address
Nejatolahy street,Engheab Avenue
City
Tehran
Postal code
Phone
+98 21 2205 6625
Fax
Email
mohammadiaz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Mahnaz Aliakbari Dehkordi
Position
Psychology, PhD
Other areas of specialty/work
Street address
Nejatolahy street,Engheab Avenue
City
Tehran
Postal code
Phone
+98 21 2249 1259
Fax
Email
m_akbari@pnu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Tayebeh Mohtashami
Position
Psychology, MSc
Other areas of specialty/work
Street address
Nejatolahy street, Engheab Avenue
City
Tehran
Postal code
Phone
+98 21 8890 1833
Fax
Email
t.mohtasham@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)