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IRCT20250711066445N1 IRCT 2025-07-20 Tarbiat Modares university Evaluating the effects of new counselling methods on sexual health and quality of life in infertile women with polycystic ovary syndrome MVR-CBT-INFERTILITY Investigating the effect of mindfulness-based sexual counseling, virtual reality, and cognitive-behavioral therapy on sexual function, quality of sexual life, and sexual health literacy of infertile women with polycystic ovary syndrome 2025-09-06 anticipated 80 Complete https://irct.ir/trial/84859 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: This is a two-arm, parallel, randomized, open-label clinical trial evaluating psychological interventions (mindfulness-based counseling, virtual reality, and cognitive behavioral therapy) on sexual function and quality of life in infertile women with polycystic ovary syndrome, Randomization description: In the first phase (screening), participants will be selected non-randomly using a convenience sampling method based on the study’s inclusion and exclusion criteria. After initial screening and data collection, eligible participants will be randomly assigned to intervention and control groups using block randomization (blocks of four) based on a predetermined allocation list. In the block randomization process, all eligible participants are grouped into blocks of four, and for each block, one of the six possible allocation sequences (e.g., AABB, ABAB, BBAA, etc.) is randomly selected using a random number table or computer software. Participants are then assigned to either the intervention (A) or control (B) group according to the selected sequence. Allocation concealment will be ensured using sealed, opaque envelopes. N/A Polycystic Ovary Syndrome (PCOS) in infertile women. Intervention 1: The intervention consists of a structured 8-session sexual counseling program (each session lasting 90 minutes, held once a week) designed for infertile women with polycystic ovary syndrome (PCOS). This group-based intervention (6 to 8 participants per group) incorporates mindfulness techniques (such as guided meditation and conscious breathing to reduce sexual anxiety), virtual reality (simulated scenarios to improve body image and reduce sexual anxiety), and cognitive-behavioral therapy (cognitive restructuring and behavioral exercises to modify negative beliefs and enhance marital communication). Each session includes individual assessments, interactive exercises, and homework assignments to reinforce the therapeutic process. Intervention 2: Control group: The control group will not receive any intervention except routine treatment during the study. After the research period concludes, free sexual health promotion counseling sessions will be provided to them if they wish. Yes - There is a plan to make this available What will be shared: The study protocol and findings will be provided to the applicant upon a written request to the corresponding author and approval by the Research Council of Tarbiat Modares University. When: The course access begins 12 months after the publication of results. To whom: Researchers employed at academic and scientific institutions Conditions: Use in review studies Where to obtain: After submitting a written request by the corresponding author (Shadab Shahali via email: shadab.shahali@modares.ac.ir) and obtaining approval from the Research Council of Tarbiat Modares University, the data will be provided to the applicant. How to obtain: After submitting a written request by the corresponding author (Shadab Shahali via email: shadab.shahali@modares.ac.ir) and obtaining approval from the Research Council of Tarbiat Modares University, the data will be provided to the applicant. Comments:
public Shadab Shahali
Jalal Al-Ahmad Highway,Tarbiat Modares University, Tehran
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 3811 shadab.shahali@modares.ac.ir Tarbiat modares university scientific Shadab Shahali
Jalal Al-Ahmad Highway, Tarbiat Modares University, Tehran
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 3811 shadab.shahali@modares.ac.ir Tarbiat modares university Iran (Islamic Republic of) Married women aged 18-45 years Not having any underlying disease except infertility and polycystic ovary syndrome Not taking medications that affect sexual function Not being addicted to alcohol or tobacco by the couple Not having any mental illnesses Being single and living with a spouse currently and during the study Being Iranian At least one year of unsuccessful attempts to conceive and not being pregnant No stressful event during the past month Literate in reading and writing Persian Not having uterine and pelvic problems and male-related infertility Having had sexual intercourse in the last 8 weeks Not undergoing infertility treatment. 18 years 45 years Female Becoming pregnant during the study Failure to perform the intervention regularly and correctly E28.2 Polycystic ovarian syndrome Behavior N/A The intervention consists of a structured 8-session sexual counseling program (each session lasting 90 minutes, held once a week) designed for infertile women with polycystic ovary syndrome (PCOS). This group-based intervention (6 to 8 participants per group) incorporates mindfulness techniques (such as guided meditation and conscious breathing to reduce sexual anxiety), virtual reality (simulated scenarios to improve body image and reduce sexual anxiety), and cognitive-behavioral therapy (cognitive restructuring and behavioral exercises to modify negative beliefs and enhance marital communication). Each session includes individual assessments, interactive exercises, and homework assignments to reinforce the therapeutic process. Control group: The control group will not receive any intervention except routine treatment during the study. After the research period concludes, free sexual health promotion counseling sessions will be provided to them if they wish. Sexual function. Timepoint: Baseline, 1 month post-intervention, and 2 months post-intervention. Method of measurement: Sexual function will be measured using the Female Sexual Function Index (FSFI). Sexual quality of life. Timepoint: Baseline, 1 month post-intervention, and 2 months post-intervention. Method of measurement: Sexual quality of life will be measured using the Sexual Quality of Life Questionnaire for Women (SQOL-F). Sexual health literacy. Timepoint: Baseline, 1 month post-intervention, and 2 months post-intervention. Method of measurement: Sexual health literacy will be measured using the Sexual Health Literacy for Adults (SHELA) assessment tool. No secondary outcome variables identified; the study focuses solely on primary outcomes. Timepoint: Not applicable. Method of measurement: Not applicable. Tarbiat Modares university Approved 2025-07-09 Ethics Committee of Tarbiat Modares University Jalal Al-Ahmad Highway/Tarbiat Modares University, Tehran TEHRAN Tehran Iran (Islamic Republic of)