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

To determine the effect of BETTER model–based counseling compared with routine care on sexual quality of life and sexual satisfaction among women with polycystic ovary syndrome.

A single-blind, parallel-group, randomized controlled trial with 70 participants, using block randomization; trial phase: Not Applicable.

This trial will be conducted at selected clinics affiliated with Isfahan University of Medical Sciences. Eligible participants will be enrolled after informed consent and baseline assessment and will be allocated to two groups using block randomization. The statistical analyst will be blinded to group allocation.

The inclusion criteria will include women aged 18–45 years with polycystic ovary syndrome diagnosed according to the Rotterdam criteria, who are married, able to read and write Persian, reporting reduced sexual quality of life or sexual dissatisfaction, and willing to provide written informed consent. The exclusion criteria will include pregnancy or postpartum period, menopause, severe psychiatric disorders, chronic medical conditions or medications affecting sexual function, and major stressful life events during the previous 3 months.

Participants will be randomly allocated into two groups: the intervention group will receive BETTER model–based counseling plus routine care, while the control group will receive routine care only.

Sexual quality of life; Sexual satisfaction

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.

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.