Effect of virtual based cognitive behavioral therapy of vaginism in Iranian women: RCT
Design
The study will be performed on 40 women with primary vaginism aged 18-40 years who refer to sexual dysfunction treatment centers. Block randomization is used for randomization using Internet tools.
Settings and conduct
Sampling will be performed among women with primary vaginism aged 18-40 years who refer to treatment centers for sexual disorders and with an initial diagnosis by a team's sexologist. Sampling will be available in such a way that the researcher uses the telephone number in the file of eligible people and after giving explanations about the objectives and how to conduct the research, invites them to a specific time to complete the questionnaires. For random allocation, block randomization by Internet tools will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diagnosis of vaginismus based on DSM-5 by a sexologist
Marital status and living with a spouse
Age: 18-40 years
No pregnancy
Be literate Using the Internet to communicate educational counselingve sufficient Persian skills in reading and writing
Have sufficient Persian skills in reading and writing
Exclusion criteria:
Psychosis or Dissociative symptoms in the past or present
Post Traumatic Stress Disorder(PTSD)
Traumatization due tosexual abuse in the past or the present
Substance abuse or dependency in the present
Moderate or severe depressionor bipolar disorder in the present
Currently being treated for vaginismus
Patients with physical causes leading to vaginismus
Sexual dysfunction in partner
Pregnancy
Death of a spouse
Divorce
People who have not participated in the study for 2 sessions or more
Intervention groups
Women with primary vaginism aged 18-40 years referred to sex disorder treatment centers
Main outcome variables
vaginal penetration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161230031662N11
Registration date:2021-08-29, 1400/06/07
Registration timing:registered_while_recruiting
Last update:2021-08-29, 1400/06/07
Update count:0
Registration date
2021-08-29, 1400/06/07
Registrant information
Name
Razieh Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
raziehlotfi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2021-10-07, 1400/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of virtual based cognitive behavioral therapy of vaginism in Iranian women: a randomized controlled clinical trial
Public title
The effectiveness of virtual based cognitive behavioral therapy in vaginism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of vaginismus based on DSM-5 by a sexologist
Marital status and living with a spouse
Age: 18-40 years
No pregnancy
Be literate Using the Internet to communicate educational counselingve sufficient Persian skills in reading and writing
Have sufficient Persian skills in reading and writing
Exclusion criteria:
Psychosis or dissociative symptoms in the past or present
Post Traumatic Stress Disorder(PTSD)
Traumatization due tosexual abuse in the past or the present,
Substance abuse or dependency in the present
Moderate or severe depressionor bipolar disorder in the present
Currently being treated for vaginismus
Patients with physical causes leading to vaginismus
Sexual dysfunction in partner
Pregnancy
Death of a spouse
Divorce
People who have not participated in the study for 2 sessions or more
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method is used in the present study. This will be done using a random block internet tool via http://www.sealedenvelope.com/simple-randomiser/v1/lists. Block size is determined 4 and allocation was done upon arranges of codes in the blocks. Randomization will concealed in sequentially numbered, sealed, opaque envelopes. After producing randomization sequence, 80 opaque envelopes will be provided and each randomization sequence is recorded on a card, then placed in the envelope in order. To keep concealment, envelopes are numbered too. The envelope is sealed and placed in a box in order. At the beginning of the registration of participants, according to the order of entry of eligible participants to study, one of the envelopes will be opened and the assigned group of the participant will be determined.
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 Alborz university of medical sciences
Street address
Alborz University of Medical Sciences, Shahrake Edari, North Taleghani, Azimieh, Karaj
City
Alborz
Province
Alborz
Postal code
3149779453
Approval date
2021-08-02, 1400/05/11
Ethics committee reference number
IR.ABZUMS.REC.1400.113
Health conditions studied
1
Description of health condition studied
vaginismus
ICD-10 code
Z70
ICD-10 code description
Counseling related to sexual attitude, behavior and orientation
Primary outcomes
1
Description
penetration
Timepoint
Before the intervention, immediately after the intervention, 4 weeks after the end of the intervention
Method of measurement
Through questionnaires
Secondary outcomes
1
Description
Sexual function
Timepoint
Before the intervention , Immediately after the intervention, 4 weeks after the end of the intervention
Method of measurement
Rosen's sexual function Questionnaire(FSFI)
Intervention groups
1
Description
The intervention consists of eight sessions composed of modules for psychoeducation, cognitive restructuring, relaxation exercises, sensate focus, attention-focusing for pain-management, body exposure andl self-exploration, desensitization and gradual exposure with fingers or dilators and preparation exercises for sexual intercourse, which will be performed weekly (in some cases twice a week).
Category
Behavior
2
Description
Control group: No intervention will be taken during this period For the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali Educational and Medical Center
Full name of responsible person
Dr.Razieh Lotfi
Street address
Shahid Beheshti St. - Shohada Sq. - Kamali St.
City
karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3222 2021
Email
lotfi_razieh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Assistant of Alborz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Noorisepehr
Street address
North Taleghani Street, Azimieh
City
karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 4255
Email
dr.noorisepehr@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistant of Alborz 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
Alborz University of Medical Sciences
Full name of responsible person
Maedeh Bina
Position
BCs of Midwiery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Nobovvat Square, Karaj
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7685
Email
maedehbina64@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
A;borz University of Medical Sciences
Full name of responsible person
Razieh Lotfi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
1st Golestan Street, South Eshteraki Boulevard, Baghestan, Karaj
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 912 765 5855
Email
Lotfi_razieh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Maedeh Bina
Position
BCs in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Nobovvat Square, Karaj
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 911 382 2280
Email
maedehbina64@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total potential data can be shared after unidentifiable people
When the data will become available and for how long
Data will be in access 6 months after publishing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
En Scientific studies
From where data/document is obtainable
Using Email Address :
Lotfi_razieh@yahoo.com
What processes are involved for a request to access data/document