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IRCT20190427043391N1 IRCT 2019-05-06 Rasht University of Medical Sciences The efficacy 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 2018-04-14 anticipated 30 Complete https://irct.ir/trial/39092 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Vaginismus Disorder. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Alireza Eivazi
The office dr Eivazi, Alley Tavakoli, West Karimi, Square Shohada, Lahijan Town
Lahijan Iran (Islamic Republic of) 4418693814 +98 13 4223 0063 Eivazi_ar@yahoo.com University of Applied Sciences Red Crescent Gilan scientific Alireza Eivazi
The office dr Eivazi, Alley Tavakoli, West Karimi, Square Shohada, Lahijan Town
Lahijan Iran (Islamic Republic of) 4418693814 +98 13 4223 0063 Eivazi_ar@yahoo.com University of Applied Sciences Red Crescent Gilan Iran (Islamic Republic of) 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) 19 years 35 years Female 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 F52.6 Dyspareunia not due to a substance or known physiological condition Behavior Treatment - Devices Treatment - Other 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. 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. 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. Intercourse. Timepoint: At the end of the intervention. Method of measurement: Person report. Desire. Timepoint: The beginning of the study (before the intervention) and after the intervention. Method of measurement: The Female Sexual Function Index. Arousal. Timepoint: The beginning of the study (before the intervention) and after the intervention. Method of measurement: The Female Sexual Function Index. Lubrication. Timepoint: The beginning of the study (before the intervention) and after the intervention. Method of measurement: The Female Sexual Function Index. Orgasm. Timepoint: The beginning of the study (before the intervention) and after the intervention. Method of measurement: The Female Sexual Function Index. Satisfaction. Timepoint: The beginning of the study (before the intervention) and after the intervention. Method of measurement: The Female Sexual Function Index. Pain. Timepoint: The beginning of the study (before the intervention) and after the intervention. Method of measurement: The Female Sexual Function Index. Rasht University of Medical Sciences Approved 2018-02-21 Ethics committee of Gilan University of Medical Sciences In front of the hospital 17 Shahrivar, Shahid Siadati Street, Namjoo Street Rasht Guilan Iran (Islamic Republic of)