Comparison of the efficacy Cognitive Behavioral Therapy, Biofeedback and combination of Cognitive Behavioral Therapy and Biofeedback On the treatment of vaginismus
Comparison of the efficacy Cognitive Behavioral Therapy, Biofeedback and combination of Cognitive Behavioral Therapy and Biofeedback On the treatment of vaginismus
Design
Number of 30 patients with Vaginismus Disorder were selected by purposeful sampling and then randomly divided into three groups in parallel with cognitive-behavioral intervention, biofeedback and combination of cognitive-behavioral therapy and biofeedback in equal parts.
Settings and conduct
Individuals of all three groups of cognitive-behavioral intervention, biofeedback and combination of cognitive-behavioral therapy and biofeedback received the first diagnosis of vaginismus on the basis of DSM-5 before the relevant interventions in the psychiatric clinic and then completed the FSFI questionnaire. After the end of the interventions, the questionnaire will again be available to the members to complete them and the level of effectiveness will be checked.
Participants/Inclusion and exclusion criteria
Entry criteria:Suffering of Type I vaginismus (unconsummated marriage)
Initial diagnosis of vaginismus based on DSM-5
Having normal cognitive levels
Having at least a cycle education
Get a score of 35-63 based on The Female Sexual Function Index (FSFI)
Non-entry criteria: Patients with vaginismus physical conditions based on gynecologic examination
Pregnancy
Ovarian tumor (vagina, Cervical and uterus)
The presence of major medical or psychiatric illnesses
Receiving psychiatric treatments at the time of study
Reception history of cognitive-behavioral training
Intervention groups
There are three intervention groups in this study. A group Receive cognitive-behavioral therapy, the second group biofeedback and the third group combination of cognitive-behavioral therapy and biofeedback.
Main outcome variables
Vaginismus, cognitive- behavioral therapy And biofeedback
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190427043391N1
Registration date:2019-05-06, 1398/02/16
Registration timing:retrospective
Last update:2019-05-06, 1398/02/16
Update count:0
Registration date
2019-05-06, 1398/02/16
Registrant information
Name
Alireza Eivazi
Name of organization / entity
University of Applied Sciences Red Crescent Gilan
Country
Iran (Islamic Republic of)
Phone
+98 13 4223 0063
Email address
eivazi_ar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-14, 1397/01/25
Expected recruitment end date
2018-08-28, 1397/06/06
Actual recruitment start date
2018-06-02, 1397/03/12
Actual recruitment end date
2018-11-14, 1397/08/23
Trial completion date
2019-03-06, 1397/12/15
Scientific title
Comparison of the efficacy Cognitive Behavioral Therapy, Biofeedback and combination of Cognitive Behavioral Therapy and Biofeedback On the treatment of vaginismus
Public title
The efficacy of Cognitive Behavioral Therapy and Biofeedback On the treatment of vaginismus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering of Type I vaginismus (unconsummated marriage)
Initial diagnosis of vaginismus based on DSM-5
Having normal cognitive levels
Having at least a cycle education
Get a score of 35-63 based on The Female Sexual Function Index (FSFI)
Exclusion criteria:
Patients with vaginismus physical conditions based on gynecologic examination
Pregnancy
Ovarian tumor (vagina, Cervical and uterus)
The presence of major medical or psychiatric illnesses
Receiving psychiatric treatments at the time of study
Reception history of cognitive-behavioral training
Age
From 19 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in three groups of cognitive-behavioral therapy, biofeedback and the combination of cognitive-behavioral therapy and biofeedback have not information on the type of intervention of other people in their group and other groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gilan University of Medical Sciences
Street address
In front of the hospital 17 Shahrivar, Shahid Siadati Street, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2018-02-21, 1396/12/02
Ethics committee reference number
IR.GUMS.REC.1396.472
Health conditions studied
1
Description of health condition studied
Vaginismus Disorder
ICD-10 code
F52.6
ICD-10 code description
Dyspareunia not due to a substance or known physiological condition
Primary outcomes
1
Description
Intercourse
Timepoint
At the end of the intervention
Method of measurement
Person report
Secondary outcomes
1
Description
Desire
Timepoint
The beginning of the study (before the intervention) and after the intervention
Method of measurement
The Female Sexual Function Index
2
Description
Arousal
Timepoint
The beginning of the study (before the intervention) and after the intervention
Method of measurement
The Female Sexual Function Index
3
Description
Lubrication
Timepoint
The beginning of the study (before the intervention) and after the intervention
Method of measurement
The Female Sexual Function Index
4
Description
Orgasm
Timepoint
The beginning of the study (before the intervention) and after the intervention
Method of measurement
The Female Sexual Function Index
5
Description
Satisfaction
Timepoint
The beginning of the study (before the intervention) and after the intervention
Method of measurement
The Female Sexual Function Index
6
Description
Pain
Timepoint
The beginning of the study (before the intervention) and after the intervention
Method of measurement
The Female Sexual Function Index
Intervention groups
1
Description
Intervention group1: Cognitive-behavioral intervention consists of 10 sessions of 45-minute therapy. A major part of the Therapeutic Plan is the creation of a therapeutic relationship, the teaching of body anatomy, identifying and challenging with illogical and negative beliefs associated with sexuality, the teaching of Relaxation and Diaphragmatic breathing, and sexual imagination with it and their practice at home as a homework.
Category
Behavior
2
Description
Intervention group 2: Biofeedback intervention consists of 10 sessions of 45-minute therapy. The therapeutic protocol includes an explanation of the biofeedback treatment process, diaphragmatic breathing training and relaxation, surface massage and tensile movements of the edenturer; determining and recording the threshold of vaginal muscle contraction on the diagram on the monitor surface and attempting to reduce the contraction threshold by relaxing the pelvic floor muscles Gradually during the sessions to reach the bottom of the threshold; the use of superficial biofeedback on Eddator's muscles and gradually advancing the patient's finger and his wife (at home) as a dilator and practicing at home.
Category
Treatment - Devices
3
Description
Intervention group 3: Cognitive-behavioral and biofeedback combined intervention includes 10 sessions of 45-minute therapy.The therapeutic protocol includes the creation of a therapeutic relationship, the teaching of body anatomy, identifying and challenging with illogical and negative beliefs associated with sexuality, explanation of the biofeedback treatment process, diaphragmatic breathing training and relaxation, surface massage and tensile movements of the edenturer; determining and recording the threshold of vaginal muscle contraction on the diagram on the monitor surface and attempting to reduce the contraction threshold by relaxing the pelvic floor muscles Gradually during the sessions to reach the bottom of the threshold; the use of superficial biofeedback on Eddator's muscles and gradually advancing the patient's finger and his wife (at home) as a dilator and practicing at home.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialist Consulting Center And Mental Health of Dr. Eyvazi
Full name of responsible person
Alireza Eivazi
Street address
Dr. Eyvazi's Clinic, Tavakoli alley, Shahid Karimi Avenue, Martyrs' Square
City
Lahijan
Province
Guilan
Postal code
4418693814
Phone
+98 13 4223 0063
Email
Eivazi_ar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
In front of the hospital 17 Shahrivar, Shahid Siadati Street, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5820
Email
nemati@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
University of Applied Sciences Red Crescent Gilan
Full name of responsible person
Alireza Eivazi
Position
Psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
The office dr Eivazi, Alley Tavakoli, West Karimi, Square Shohada, Lahijan Town
City
Lahijan
Province
Guilan
Postal code
4418693814
Phone
+98 13 4223 0063
Fax
Email
Eivazi_ar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Applied Sciences Red Crescent Gilan
Full name of responsible person
Alireza Eivazi
Position
Psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
The office dr Eivazi, Alley Tavakoli, West Karimi, Square Shohada, Lahijan Town
City
Lahijan
Province
Guilan
Postal code
4418693814
Phone
+98 13 4223 0063
Fax
Email
Eivazi_ar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of Applied Sciences Red Crescent Gilan
Full name of responsible person
Alireza Eivazi
Position
Psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
The office dr Eivazi, Alley Tavakoli, West Karimi, Square Shohada, Lahijan Town
City
Lahijan
Province
Guilan
Postal code
4418693814
Phone
+98 13 4223 0063
Fax
Email
Eivazi_ar@yahoo.com
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