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IRCT20260723070319N1 IRCT 2026-07-27 Islamic Azad University Effect of the BETTER Model on Sexual Quality of Life and Sexual Satisfaction in Women with Polycystic Ovary Syndrome Comparison of the Effects of the BETTER Model and Routine Care on Sexual Quality of Life and Sexual Satisfaction in Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial 2026-08-23 anticipated 60 Recruiting https://irct.ir/trial/91934 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be randomized using block randomization with variable block sizes of 4 and 6 and an allocation ratio of 1:1. The individual participant will be the unit of randomization. The random allocation sequence will be generated by an independent statistician using an online randomization program. After completion of baseline assessments, participants will be randomly assigned to either the intervention group or the control group according to the generated sequence. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes (SNOSE) that will be prepared by a researcher who will not be involved in participant recruitment, intervention delivery, or outcome assessment. The envelopes will be opened sequentially only after participant enrollment and completion of baseline data collection. No stratified randomization will be used in this study, Blinding description: Due to the nature of the BETTER model–based counseling intervention, blinding of participants, the principal investigator delivering the intervention, and healthcare providers will not be feasible. In addition, the data collector will be aware of group allocation because of direct contact with the participants. However, the statistical analyst will remain blinded to group allocation, and the study data will be provided in a coded, anonymized format to ensure that the statistical analyses are performed without knowledge of treatment assignment. Therefore, this trial will be conducted as a single-blind study, with blinding limited to the statistical analyst. N/A Polycystic Ovary Syndrome. Intervention 1: Intervention group: Participants will receive four individual BETTER model–based educational counseling sessions, delivered once weekly, with each session lasting 60–90 minutes. The counseling will be provided according to the six components of the BETTER model, including Bring up, Explain, Tell, Timing, Educate, and Record, in addition to routine care. Intervention 2: Control group: Participants will receive routine care provided at the clinic only and will not receive BETTER model–based counseling. 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 De-identified individual participant data will be made available upon reasonable request after publication of the primary study results, subject to approval by the principal investigator and in accordance with ethical and confidentiality requirements.
public Niloufar Ramineh
Astara Branch, Islamic Azad University, Astara, Gilan Province, Iran
Astara Iran (Islamic Republic of) 4371614645 +98 13 4480 2220 niloufar.ramineh71@gmail.com Islamic Azad University scientific Niloufar Ramineh
Astara Branch, Islamic Azad University, Astara, Gilan Province, Iran
Astara Iran (Islamic Republic of) 4371614645 +98 13 4480 2220 niloufar.ramineh71@gmail.com Islamic Azad University Iran (Islamic Republic of) Women with a confirmed diagnosis of polycystic ovary syndrome (PCOS) based on the Rotterdam criteria, aged 18–45 years, married and living with their spouse, diagnosed with PCOS for at least 6 months, able to read and write Persian, reporting reduced sexual quality of life or sexual dissatisfaction at baseline assessment, with no participation in psychosexual counseling programs during the previous 6 months, willing to participate in the study, and providing written informed consent. 18 years 45 years Female Pregnancy or postpartum period, menopause, severe psychiatric disorders or current psychiatric treatment, chronic medical conditions known to substantially affect sexual function (e.g., uncontrolled diabetes, cardiovascular disease, thyroid disorders, neurological diseases, or malignancy), current use of medications affecting sexual function, and major stressful life events during the previous 3 months. E28.2 Polycystic ovarian syndrome Lifestyle Lifestyle Intervention group: Participants will receive four individual BETTER model–based educational counseling sessions, delivered once weekly, with each session lasting 60–90 minutes. The counseling will be provided according to the six components of the BETTER model, including Bring up, Explain, Tell, Timing, Educate, and Record, in addition to routine care. Control group: Participants will receive routine care provided at the clinic only and will not receive BETTER model–based counseling. Sexual quality of life, assessed using the Sexual Quality of Life–Female (SQOL-F) questionnaire at baseline, immediately after the intervention, and 8 weeks after the intervention. Timepoint: At baseline (before the intervention), immediately after completion of the intervention, and 8 weeks after completion of the intervention. Method of measurement: Sexual Quality of Life–Female Questionnaire. Sexual satisfaction, assessed using the Larson Sexual Satisfaction Questionnaire (LSSQ) at baseline, immediately after the intervention, and 8 weeks after the intervention. Timepoint: At baseline (before the intervention), immediately after completion of the intervention, and 8 weeks after completion of the intervention. Method of measurement: Larson Sexual Satisfaction Questionnaire. Islamic Azad University Approved 2026-07-20 Ethics Committee of Islamic Azad University, Yazd Branch Safaieh, Prof. Hesabi Square, Islamic Azad University, Yazd Branch, Yazd, Iran Yazd Yazd Iran (Islamic Republic of)