]>
IRCT20221120056555N1 IRCT 2023-02-10 Qazvin University of Medical Sciences Comparing effect of two counseling method (Leventhal's self-regulation model and BETTER Model) on Sexual Satisfaction & function in Women with multiple sclerosis: A three armed randomized controlled trial Comparing effect of two counseling method (Leventhal's self-regulation model and BETTER Model) on Sexual Satisfaction & function in Women with multiple sclerosis: A three armed randomized controlled trial 2023-03-06 anticipated 120 Complete https://irct.ir/trial/68432 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: random allocation is done as a block of six. For random allocation, balanced block design with six block sizes will be used, and random allocation generation software will be used, and in order to hide the sequence of allocation, the papers identifying the groups of people are respectively placed inside the envelopes in the opaque package and They are coded in the same order, and in this way, code one is assigned to the people of the Leventhal intervention group, code two to the people of the better intervention group, and code three to the control group. N/A multiple sclerosis. Intervention 1: Intervention group1: three training sessions using Leventhal's self-regulation model individually and face-to-face for 60 minutes weekly, including description of the nature of the disease, symptoms and causes related to it, the consequences of the disease (sexual), the course of the disease, and how to control it and disease care. Intervention 2: Intervention group 2: Three sexual counseling sessions, each session lasting at least 60 and maximum 100 minutes, according to the BETTER model, once a week: • The first session, implementation of the first and second steps of the model - Explain, Bring up • The second session, the implementation of the third and fourth steps of the Time-Tell resources model. The third session, the implementation of the fifth and sixth steps of the Educate model. Intervention 3: Control group: They will not receive any intervention from the research team, but they will receive their routine examinations by the specialist and the treatment team. Yes - There is a plan to make this available What will be shared: Study data can be shared after de-identifying individuals When: 6 months after the results are published To whom: The data of this research will be available for researchers working in academic and scientific institutions Conditions: The data obtained from this study will only be available for conducting similar studies Where to obtain: m.elahinia@qums.ac.ir mehrnoosh elahinia How to obtain: Initial correspondence via e-mail, face-to-face meeting and presentation of a work proposal similar to the current research, providing sufficient evidence for the similarity of your research with the current research, study of the proposal by the current research executive, decision-making and announcement of the result by the current research executive to the researcher in order to obtain the available data. Placing the data file for use on site Comments:
public Mehrnoosh Elahinia
No.510,royayi alley, lakan blvd , rasht town , guilan
Qazvin Iran (Islamic Republic of) 4145753345 009833336001 m.elahinia@qums.ac.ir Qazvin University of Medical Sciences scientific Mehrnoosh Elahinia
No.510,royayi alley, lakan blvd , rasht town , guilan
Qazvin Iran (Islamic Republic of) 4145753345 009833336001 m.elahinia@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) willing to participate in the study able to understand and speak Persian language married women (at least one year) Have definitive Diagnosis of MS by a neurologist using the McDonald Criteria To be at a stage of MS disease that can carry out routine activities _ EDSS score < 5 not in early diagnosis phase 18 years no limit Female have depression and taking medication participate in other counseling sessions at the same time pregnancy breast feeding in exacerbation phase G35 Multiple sclerosis Behavior Behavior N/A Intervention group1: three training sessions using Leventhal's self-regulation model individually and face-to-face for 60 minutes weekly, including description of the nature of the disease, symptoms and causes related to it, the consequences of the disease (sexual), the course of the disease, and how to control it and disease care Intervention group 2: Three sexual counseling sessions, each session lasting at least 60 and maximum 100 minutes, according to the BETTER model, once a week: • The first session, implementation of the first and second steps of the model - Explain, Bring up • The second session, the implementation of the third and fourth steps of the Time-Tell resources model. The third session, the implementation of the fifth and sixth steps of the Educate model. Control group: They will not receive any intervention from the research team, but they will receive their routine examinations by the specialist and the treatment team Sexual satisfaction. Timepoint: Before the intervention, one and three months after the end of the intervention. Method of measurement: Sexual satisfaction scale for women. Sexual function. Timepoint: Before the intervention, one and three months after the end of the intervention. Method of measurement: Female Sexual Function Index. Qazvin University of Medical Sciences Approved 2023-02-05 Ethics Committee of Qazvin University of Medical Sciences and Healthcare Services Qazvin - Shahid Beheshti Blvd. - not reaching Valiasr intersection - facing Shahid Beheshti Park - Maudet sub alley - No. 16 - University of Medical Sciences Research and Technology Deputy Building - 1st floor - University Research Ethics Committee Unit Qazvin Qazvin Iran (Islamic Republic of)