Comparing the Effectiveness of Systemic Sex Therapy and single-session therapy on successful penetration, marital satisfaction, sexual distress, experience of pain intensity, and the multidimensional perspective of the patient and spouse in vaginismus patients.
Design
Two arm parallel groups non-randomised trial, without control group, without blinding, on 30 patients.
Settings and conduct
Place of study: Systemic Sex Therapy at the Kayhan Psychology Clinic in Tehran and Single-session Treatment at the Sexual Health Clinic of Imam Khomeini Hospital in Tehran; Study population: 30 women with vaginismus. No blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: married women over 18 years old; Active avoidance of penetration during the last 6 months and no experience of penetration; presence of fear, severe anxiety or significant pain when trying to penetrate; Spouse's presence in treatment.
Exclusion criteria: Visiting a doctor or a psychiatrist due to the presence of a known medical or acute mental illness; the presence of women's diseases, including acute infections of the genital tract; pregnancy; Consumption of drugs and alcohol through the patient's statement
Intervention groups
There are two intervention groups: Systemic Sex Therapy intervention group: sex education and relaxation, gradual exposure and couple therapy in 12 one-hour sessions. Single-Session Treatment intervention group: introducing the automatic brain system and teaching independent control of vaginal muscles and practicing with the therapist's finger during the treatment session during one session.
Main outcome variables
Vaginal Penetration, Marital Satisfaction, Sexual Distress, The Intensity of pain experience and Multidimensional Perspective of Vaginal Penetration of the patient and spouse.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220307054215N1
Registration date:2023-08-26, 1402/06/04
Registration timing:prospective
Last update:2023-08-26, 1402/06/04
Update count:0
Registration date
2023-08-26, 1402/06/04
Registrant information
Name
Fatemeh Tehranchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8878 1851
Email address
mahnaz_tehranchi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of the Effectiveness of Systemic Sex Therapy and Single Session Therapy on the Treatment of Vaginismus Patients
Public title
The Effectiveness of Systemic sex therapy and Single Session therapy on Vaginismus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women over 18 years old
Trying to penetrate during the last 6 months and not experiencing penetration
Existence of active avoidance of penetration
Diploma and higher education
Presence of significant fear or extreme anxiety when trying to penetrate
Presence of significant pain when trying to penetrate
The presence of the wife in the treatment
Exclusion criteria:
Visiting a doctor or a psychiatrist due to the presence of a known medical or acute mental illness based on the patient's statement
The presence of women's diseases, including acute infections of the genital tract
Pregnancy
Consumption of drugs and alcohol through the patient's statement
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not 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
Ethics Committee of Roudhen Branch, Islamic Azad University
Street address
Ayatollah Khamenei Blvd; Rodhan
City
Ttehran
Province
Tehran
Postal code
3973188981
Approval date
2023-05-31, 1402/03/10
Ethics committee reference number
IR.IAU.R.REC.1402.015
Health conditions studied
1
Description of health condition studied
Vginismus
ICD-10 code
F52.5
ICD-10 code description
Vaginismus not due to a substance or known physiological condition
Primary outcomes
1
Description
Successful vaginal penetration
Timepoint
In the systemic sex therapy: before the intervention, at the end of the fourth week, at the end of the eighth week, and at the end of the twelfth week. In the single session therapy: before the intervention, at the end of the second week, at the end of the fourth week, at the end of the sixth week.
Method of measurement
Patient self-report
Secondary outcomes
1
Description
Female Sexual Distress
Timepoint
In systemic sex therapy: before the intervention, at the end of the fourth week, at the end of the eighth week, and at the end of the twelfth week. In single session therapy: before the intervention, at the end of the second week, at the end of the fourth week, at the end of the sixth week.
Method of measurement
Female Sexual Distress Scale (FSDS)
2
Description
Marital Satisfaction
Timepoint
In systemic sex therapy: before the intervention, at the end of the fourth week, at the end of the eighth week, and at the end of the twelfth week. In single session therapy: before the intervention, at the end of the second week, at the end of the fourth week, at the end of the sixth week.
In systemic sex therapy: before the intervention, at the end of the fourth week, at the end of the eighth week, and at the end of the twelfth week. In single session therapy: before the intervention, at the end of the second week, at the end of the fourth week, at the end of the sixth week.
Partner Version of the Multidimensional Vaginal Penetration Disorder perspective
Timepoint
In systemic sex therapy: before the intervention, at the end of the fourth week, at the end of the eighth week, and at the end of the twelfth week. In single session therapy: before the intervention, at the end of the second week, at the end of the fourth week, at the end of the sixth week.
Method of measurement
Partner Version of the Multidimensional Vaginal Penetration Disorder Questionnaire (PV-MVPDQ)
5
Description
intensity of pain
Timepoint
In systemic sex therapy: before the intervention, at the end of the fourth week, at the end of the eighth week, and at the end of the twelfth week. In single session therapy: before the intervention, at the end of the second week, at the end of the fourth week, at the end of the sixth week.
Method of measurement
Visual Analogue Scale (VAS)
Intervention groups
1
Description
The first intervention group is Systemic sex therapy that is specifically a combination of sex therapy and couple therapy. It deals with the cognitive reconstruction of the individual from a cognitive-behavioral perspective, and in the behavioral part, in addition to the correction of couple relationships and sex education, it deals with gradual exposure to the process of penetration. In twelve one-hour sessions, to assess and correct and reconstruct dysfunctional sexual cognitions, sexual organ anatomy training, sexual communication training, mindfulness and expansion of the sexual repertoire, relaxation training, familiarization with the pain cycle, gradual exposure through graduated therapeutic dilators and regular desensitization. And couple skills training including listening and understanding, empathic message and problem solving and Consistent daily homework are discussed.
Category
Treatment - Other
2
Description
The second intervention is a single-session therapy that working on dimming the brain’s autonomous control on genitalia and pelvic muscles by handing over the power of decision, getting control over her body, and attempting to insert the therapist's or husband's finger in her vagina at the clinic and voluntarily penetrate with penis at home. This treatment uses muscle exercises to retrain and improve brain power for vaginal penetration. During a session of one hour and forty-five minutes, with the presence of the wife, he explained about the automatic system of the brain, the method of independent control over the sexual organ, finger insertion training and the technique of contracting and relaxing the muscles in the deep part of the pelvis and the movement of the zipper/muscle lift. Levatorani + contraction of the pelvic floor muscles while the doctor's finger is inside, wrist twisting and simultaneous two-person zip/lift exercise, wrist twisting and zip/lift in a three-person workout with a spouse, and providing home exercises in two parts of testing and treatment.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kayhan Counseling and Psychotherapy Center
Full name of responsible person
Fatemeh Tehranchi
Street address
Fifth floor, No. 152, West Mirzaei Zainali St., Sohrevardi St
City
Tehran
Province
Tehran
Postal code
1576984418
Phone
+98 21 8853 3497
Fax
Email
kayhan.mali1401@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
Sexual health clinic of Imam Khomeini Hospital
Full name of responsible person
Dr Effat Alsadat Merghati Khoei
Street address
Reyhaneh building; Imam Khomeini hospital; Doctor Gharib St. Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733139
Phone
+98 21 6658 1560
Fax
+98 21 6693 8885
Email
effat_mer@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neuroscience Research Institute, Tehran University of Medical Sciences
Full name of responsible person
Seyed Amirhossein Javadi
Street address
Reyhaneh Building, Imam Khomeini Hospital, Doctor Gharib St. Keshavarz Blvd.,
City
Tehran
Province
Tehran
Postal code
1419733139
Phone
+98 21 6693 8885
Email
tini@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neuroscience Research Institute, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Fatemeh Tehranchi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 9, Valiasr St., Sero St
City
Tehran
Province
Tehran
Postal code
1968956381
Phone
+98 21 8878 1851
Email
Mahnaz_tehranchi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Effat Alsadat Merghati Khoei
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Sex & Drug Tx & Prevention Clinical Trail Specialist
Street address
Sexual health clinic, Reyhaneh Building, Imam Khomeini Hospital, Doctor Gharib St. Keshavarz Blvd.,
City
Tehran
Province
Tehran
Postal code
1419733139
Phone
+98 21 6658 1560
Email
effat_mer@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Tehranchi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 9, Valiasr St., Sarv St
City
Tehran
Province
Tehran
Postal code
1968956381
Phone
+98 21 8878 1851
Email
Mahnaz_tehranchi@yahoo.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
Due to sensitive and confidential nature
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
A part of the data related to the results of the study is shared after coding the people
When the data will become available and for how long
6 months after the publication of study results
To whom data/document is available
Researchers of national and international scientific centers
Under which criteria data/document could be used
In order to use the findings in treatment and scientific research, with the permission of the ethics committee of the Islamic Azad University of Roudhen
From where data/document is obtainable
Submit the request by email to the main researcher at Mahnaz_tehranchi@yahoo.com
What processes are involved for a request to access data/document
Send the request to the main researcher's email and if approved by the ethics committee of the Islamic Azad University of Roudhen, it is possible to provide the required information via email within a period of two weeks to one month.