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IRCT20210211050324N1 IRCT 2021-06-24 Mashhad University of Medical Sciences Sexual counseling based on two models of EX-PLISSIT and BETTER Comparison the effect of sexual counseling based on two models of EX-PLISSIT and BETTER on sexual function and sexual satisfaction of women after Assisted Reproductive Treatment(ART) failure 2021-06-22 anticipated 90 Complete https://irct.ir/trial/55743 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: So far, no counseling program has been offered and implemented in Iran for women seeking treatment failure due to ART, Randomization description: Random Allocation using Random allocation software Sample of randomization sequence by randomization site 2 2 1 1 1 2 1 2 2 1 2 1 2 1 1 2 1 2 2 1 1 1 2 2 Samples are selected as available and then based on the randomly generated sequence (code 1 or 2), the women are placed in the EX-PLISSIT or BETTER group, respectively. N/A Sexual counseling. Intervention 1: Intervention group: In the EX-PLISSIT sex counseling group, 4 sessions of 60-90 minute individual counseling will be performed in 4 consecutive weekly sessions based on the EX-PLISSIT model. The first three stages of the model, namely the stages (Permission giving, Limited Information, Specific Suggestion) will be performed during 4 counseling sessions. Upon arrival to the fourth level (Intensive therapy) in each of the sessions, refer to the relevant specialist will be held. Intervention 2: Intervention group: In the sexual counseling group based on the BETTER model, 4 sessions of individual counseling of 60 to 90 minutes will be performed in 4 consecutive weekly sessions based on the BETTER model. The sessions will be in the form of a preliminary plan, assessment of the patient's sexual status with the aim of clarifying the relationship between the disease and the client's current condition, informing the client by providing correct information and initial sexual education. Completing the counseling process in the form of sexual education and training will focus on the outcome variable of the intervention, namely sexual function and satisfaction. Finally, the consultation sessions will be summarized. Intervention 3: Control group: Routine interventions will be performed in the control group. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: َAccess period starts 6 months after the results are published To whom: Researchers and students of academic institutions Conditions: With citing to the current study and without altering in data Where to obtain: Contact the author responsible for response via Email or phone:rahimisa982@mums.ac.ir Tel:09928548691 How to obtain: The request for access to data/documents will be reviewed by the researcher team Comments:
public Akram Rahimi Shandiz
Ibn Sina ST
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 rahimisa982@mums.ac.ir Mashhad University of Medical Sciences scientific ّFatemeh Zahra Karimi
Ibn Sina st, School Of Nursing and Midwifery
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 rahimisa982@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iranian and living in Mashhad Age of 18-45 years old Have at least a fifth grade education Diagnosis of primary infertility based on information in the patient's file Failure of one of the methods of assisted reproduction such as (IUI, ICSI, IVF, GIFT, ZIFT) At least 6 months passed since infertility treatment failure Not being treated for infertility now and for the past 6 months Having sex at least once a week Absence of disease that affect sexual function in woman and her spouse Not taking drugs that affect sexual function by the woman and her spouse Non-addiction to tobacco and alcohol by woman and her spouse Absence of sexual dysfunction in the spouse Absence of severe depression, stress or anxiety according to the DASS-21 scale Not receiving sexual counseling for the past 6 months Having a device to use cyberspace 18 years 45 years Female Absence from a counseling session Reluctance to continue cooperation Occurrence of stressful events during the study Prevention Prevention N/A Intervention group: In the EX-PLISSIT sex counseling group, 4 sessions of 60-90 minute individual counseling will be performed in 4 consecutive weekly sessions based on the EX-PLISSIT model. The first three stages of the model, namely the stages (Permission giving, Limited Information, Specific Suggestion) will be performed during 4 counseling sessions. Upon arrival to the fourth level (Intensive therapy) in each of the sessions, refer to the relevant specialist will be held. Intervention group: In the sexual counseling group based on the BETTER model, 4 sessions of individual counseling of 60 to 90 minutes will be performed in 4 consecutive weekly sessions based on the BETTER model. The sessions will be in the form of a preliminary plan, assessment of the patient's sexual status with the aim of clarifying the relationship between the disease and the client's current condition, informing the client by providing correct information and initial sexual education. Completing the counseling process in the form of sexual education and training will focus on the outcome variable of the intervention, namely sexual function and satisfaction. Finally, the consultation sessions will be summarized. Control group: Routine interventions will be performed in the control group. Female sexual function. Timepoint: Before sexual counselling and 4 weeks after last counseling session. Method of measurement: Score obtained by the subject of the Female Sexual Function Index (FSFI) questionnaire. This questionnaire with 19 questions examines women's sexual function in 6 domains of desire(6 questions), arousal(4 questions), lubrication(4questions), orgasm(3 questions), pain discomfort(3 questions) and sexual satisfaction(3questions). The full-scale score is obtained by adding the six domain scores. Higher scores indicates greater sexual functioning. The overall score is a minimum of 2 and a maximum of 6. Women's sexual satisfaction. Timepoint: Before sexual counselling and 4 weeks after last counseling session. Method of measurement: Score obtained by the subject of the Sexual Satisfaction Scale of Women(sssw). This questionnaire contains 30 questions. Scoring is strongly agree(score 1), slightly agree(score 2), neither agree nor disagree ( score 3), slightly disagree(score 4) and strongly disagree(score 5). Questions 1, 4, 5, 6, 9, 10, 11, 12 are scored in reverse. Scores of each domain are obtained from the sum of the scores of that domain. Higher scores indicates greater sexual satisfaction. Mashhad University of Medical Sciences Approved 2021-05-23 Ethics Committee of Mashhad University of Medical sciences School of Nursing and Midwifery, Ibn Sina St, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)