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IRCT20220123053808N1 IRCT 2022-09-11 University of Lorestan The effect of extracranial direct current stimulation, schema therapy on vaginismus Compare effectiveness of transcranial direct current stimulation (Tdcs), schema therapy and combination therapy on anxiety, sexual pain and executive functions in women with vaginismus 2022-07-23 anticipated 60 Complete https://irct.ir/trial/61522 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The statistical sample will include 60 female patients suffering from vaginismus disorder who will be selected from the statistical population as available sampling. In order to randomly assign the subjects in experimental and control groups, as well as to avoid wasting time until the number of sample people is completely completed, the method of random blocks of 8 will be used. The size of all blocks is equal and in each block there are 2 people in the first intervention group (group A), 2 people in the second intervention group (group B), 2 people in the third intervention group (group C) and 2 people in the control group (group D) will be placed randomly. The randomization tool will be the Random Allocation software. In this way, the output of the software includes different modes of AABBCCDD random order, for each of the blocks, a different order is applied to assign the participants to the study groups. In this process, the order of participants based on blocks cannot be predicted. 2-3 Vaginismus. Intervention 1: The first intervention group: providing transcranial electrical stimulation of the brain using direct current (tDCS) in the form of ten 20-minute sessions with an intensity of two milliamps and anodic electrical stimulation of the frontal cortex of the left hemisphere (f3) and the cathode in the right prefrontal cortex (fp2) will be placed with an intensity of 2 milliamps. In general, the treatment sessions will be held once a day for three weeks. Intervention 2: The second intervention group: The treatment scheme is a treatment method based on Yang's scheme, which is implemented on clients with vaginismus disorder. This treatment process is carried out during eight treatment sessions in the form of two sessions of one and a half hours each week. Intervention 3: The third intervention group: combining two treatment protocols: protocol one: providing transcranial electrical stimulation of the brain using direct current (tDCS) in the form of ten 20-minute sessions with an intensity of two milliamps and anodic electrical stimulation of the frontal cortex area of ​​the left hemisphere (f3) And the cathode will be placed in the right prefrontal cortex (fp2) with an intensity of 2 milliamps. In general, the treatment sessions will be held once a day for three weeks. Protocol two: The treatment scheme is a treatment method based on Yang's scheme, which will be used on clients with vaginismus disorder. This therapeutic process will be implemented during eight therapeutic sessions in the form of two sessions of one and a half hours each week. Intervention 4: The fourth intervention group: the control group that receives sham stimulation. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: Regression analysis is allowed on the delivered data Where to obtain: Motahera Nosratabadi email nosratabadi.mo@fh.lu.ac.ir How to obtain: By writing a formal request and the reason for needing access to the data and writing a little bit of your research resume Comments:
public motahareh nosratabadi
Khorram abad
Khorram abad Iran (Islamic Republic of) 6815144316 +98 921 076 1741 motinosi1367@gmail.com the university of lorestan scientific Motahareh Nosratabadi
Lorestan Province - Khorramabad City - 5 km of Tehran Road - Lorestan University Central Organization
khorram abad Iran (Islamic Republic of) 68151-44316 +98 66 3312 0661 motinosi1367@gmail.com the university of lorestan Iran (Islamic Republic of) All women diagnosed with vaginismus disorder who have at least a diploma. All women diagnosed with vaginismus disorder who do not have psychotic symptoms. All women diagnosed with vaginismus disorder who do not have substance abuse and psychological disorders (as diagnosed by a psychiatrist or psychologist). All women diagnosed with vaginismus disorder who do not have gynecological diseases (such as infection). All women diagnosed with vaginismus disorder who have been married for at least 1 to 3 years. 18 years 50 years Female All women who have any disorder except vaginismus disorder. All women who have symptoms similar to vaginismus but do not have a Gynecologist diagnosis. All women who are not married or have been married for less than a year. All women who are under 18 years old and over 50 years old. All women who have symptoms of psychosis and take nerve medication. All women whose educational qualification is below diploma. N94.2 Vaginismus Treatment - Devices Treatment - Other Treatment - Other N/A The first intervention group: providing transcranial electrical stimulation of the brain using direct current (tDCS) in the form of ten 20-minute sessions with an intensity of two milliamps and anodic electrical stimulation of the frontal cortex of the left hemisphere (f3) and the cathode in the right prefrontal cortex (fp2) will be placed with an intensity of 2 milliamps. In general, the treatment sessions will be held once a day for three weeks. The second intervention group: The treatment scheme is a treatment method based on Yang's scheme, which is implemented on clients with vaginismus disorder. This treatment process is carried out during eight treatment sessions in the form of two sessions of one and a half hours each week. The third intervention group: combining two treatment protocols: protocol one: providing transcranial electrical stimulation of the brain using direct current (tDCS) in the form of ten 20-minute sessions with an intensity of two milliamps and anodic electrical stimulation of the frontal cortex area of ​​the left hemisphere (f3) And the cathode will be placed in the right prefrontal cortex (fp2) with an intensity of 2 milliamps. In general, the treatment sessions will be held once a day for three weeks. Protocol two: The treatment scheme is a treatment method based on Yang's scheme, which will be used on clients with vaginismus disorder. This therapeutic process will be implemented during eight therapeutic sessions in the form of two sessions of one and a half hours each week. The fourth intervention group: the control group that receives sham stimulation. Primary outcome: sexual pain score. Timepoint: 1 to 5 days before the intervention and 1 to 5 days after the intervention. Method of measurement: McGill pain questionnaire. Secondary outcome: anxiety score. Timepoint: 1 to 5 days before the intervention and 1 to 5 days after the intervention. Method of measurement: Kettle Anxiety Questionnaire. Individual's executive performance scores. Timepoint: 1 to 5 days before the intervention and 1 to 5 days after the intervention. Method of measurement: Nback memory test, Wisconsin test, Semantic Stroop test. Sexual pain score. Timepoint: Before intervention and after intervention. Method of measurement: McGill Sexual Pain Questionnaire 22 questions. Anxiety. Timepoint: Before intervention and after intervention. Method of measurement: Kettle Anxiety Questionnaire 40 questions. Executive functions. Timepoint: Before intervention and after intervention. Method of measurement: Semantic Strope, NB Memory Test, Wisconsin Test. University of Lorestan Approved 2022-07-27 Ethics committee of Lorestan University of Medical Sciences Moalem St., Shahid Anoushirvan Rezaei Square, University of Medical Sciences Khorram abad Lorestan Iran (Islamic Republic of)