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IRCT20120414009463N63 IRCT 2021-03-17 Tehran University of Medical Sciences The effect of sexual counseling based on EX‑PLISSIT model on sexual function in Systemic Lupus Erythematosus The effect of sexual counseling based on EX‑PLISSIT model on improving the sexual function of married women with Systemic Lupus Erythematosus 2021-04-03 anticipated 110 Complete https://irct.ir/trial/52685 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Sampling of this study will be random using block method. In this way, all eligible people enter the study after providing complete explanations and obtaining informed consent and are randomly placed in one of the two intervention or control groups with a quadruple blocking method. In this way, we will consider the letter A for the intervention group and the letter B for the control group. Then write all the permutation compounds of the letters A, A and B, B, which are 6 combinations (AABB for combination 1, ABBA for combination 2, etc.) and from combinations 1 to 6, a combination will be randomly selected. For example, if combination 1 is selected, it means that the first and second people will be in the intervention group and the third and fourth people will be in the control group. Sampling will continue until the desired number of samples in each group is reached. N/A Systemic Lupus Erythematosus. Intervention 1: Intervention group: Participants in the study who have inclusion criteria will be randomly assigned to the group receiving sexual counseling by quadruple blocking method. Consulting will be based on the EX-PLISSIT model and the content of the sessions will start with teaching a series of topics and then continue in the form of questions and answers. Intervention 2: Control group: Participants in the study who meet the inclusion criteria will be randomly assigned to the control group using the quadruple blocking method. This group will not receive any sexual counseling during the study. At the end of the research, an educational booklet will be provided to them. 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 There is no more information.
public Dr. Zahra Behboodi Moghadam
School of Nursing and Midwifery; Nosrat Sharghi street; Tohid square
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 behboodi@tums.ac.ir Tehran University of Medical Sciences scientific Dr. Zahra Behboodi Moghadam
School of Midwifery and Nursing; Tohid square
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 behboodi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Married women older than 18 years satisfaction to participate in the study Having Iranian nationality Having the ability to read and write 18 years no limit Female Menopause Pregnancy Participate in any other training class Taking hormonal drugs or drugs that affect sex Depression, anxiety and severe stress according to the score that each person gets from the DASS-21 questionnaire Physical or psychological problems affecting sexual intercourse M32 Systemic lupus erythematosus (SLE) Behavior Behavior Intervention group: Participants in the study who have inclusion criteria will be randomly assigned to the group receiving sexual counseling by quadruple blocking method. Consulting will be based on the EX-PLISSIT model and the content of the sessions will start with teaching a series of topics and then continue in the form of questions and answers. Control group: Participants in the study who meet the inclusion criteria will be randomly assigned to the control group using the quadruple blocking method. This group will not receive any sexual counseling during the study. At the end of the research, an educational booklet will be provided to them. Sexual function score in FSFI questionnaire. Timepoint: Before intervention, 8 and 12 weeks after intervention. Method of measurement: DASS-21, FSFI, demographic questionnaire. Tehran University of Medical Sciences Approved 2020-11-27 Ethics Committee of Tehran University of Medical Sciences Sixth Floor; Headquarters Building of Tehran University of Medical Sciences; at the corner of Ghods street; Keshavarz Blvd; Tehran Tehran Iran (Islamic Republic of)