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IRCT20260602069613N1 IRCT 2026-09-10 Kerman University of Medical Sciences Comparison the Effect of BETTER Sexual Counseling Model (in-person and online) on Sexual Self-Concept in Women with Polycystic Ovary Syndrome Comparison the Effect of BETTER Sexual Counseling Model (in-person and online) on Sexual Self-Concept in Women with Polycystic Ovary Syndrome 2026-09-18 anticipated 63 Recruiting https://irct.ir/trial/90589 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be randomly allocated to three groups (face-to-face, online, and control) using block randomization with a block size of nine. The random allocation sequence will be generated by an individual independent of the research team using the online randomization service available at https://www.sealedenvelope.com/simple-randomiser/v1/lists. To minimize selection bias, allocation concealment will be ensured through the use of sequentially numbered, opaque, sealed envelopes. These envelopes will be prepared and maintained by an individual independent of the research team and will contain the assigned group codes. The researcher will remain unaware of the participant's group assignment until the envelope is opened. Due to the nature of the intervention, blinding of participants and the researcher will not be feasible. However, to reduce measurement bias, the statistical data analyst will be blinded to group allocation throughout the analysis process, Blinding description: Due to the nature of the intervention, blinding of participants and the researcher will not be feasible. However, to reduce measurement bias, the statistical data analyst will be blinded to group allocation throughout the analysis process. N/A Polycystic ovarian syndrome. Intervention 1: Intervention Group 1 (Online Intervention Group): Participants in the online intervention group will receive BETTER model-based sexual counseling in four weekly individual sessions, each lasting 60–90 minutes. The content of the sessions will be developed according to the six stages of the BETTER model.In the online intervention group, participants will receive four weekly sexual counseling sessions through online chat via a private page on an accessible domestic or international messaging platform. Educational materials will be delivered in the form of audio files, video files, and written text, with the possibility of real-time voice communication with the researcher.A reminder text message will be sent one day before each session. Participants will be asked to be online at the scheduled time, ask their questions, and receive the required counseling from the researcher. To ensure adherence to the intervention and engagement with the educational content, participants will be asked questions about the topics covered in the previous session before the content of each new session is delivered, and these will be reviewed at the beginning of the session. Reminder messages regarding completion of assigned tasks will also be sent throughout the intervention period.The counseling sessions will be conducted by a trained MSc student in Midwifery Counseling under the supervision of a PhD in Reproductive Health. All sessions will be conducted with full respect for participant privacy and confidentiality. All participants will complete a demographic and obstetric characteristics questionnaire before the intervention. In addition, the Persian version of the 78-item Multidimensional Sexual Self-Concept Questionnaire (MSSCQ) will be completed before the intervention, immediately after the intervention, and four weeks after completion of the counseling sessions. Intervention 2: Intervention Group 2 (Face-to-Face Intervention Group): Participants in the face-to-face intervention group will receive BETTER model-based sexual counseling in four weekly individual sessions, each lasting 60–90 minutes, delivered in person. The content of the sessions will be identical in both the face-to-face and online groups and will be designed based on the six stages of the BETTER model.A reminder text message will be sent one day before each session. Sessions will be conducted at the data collection site in a private room with appropriate lighting and temperature, ensuring full participant confidentiality.Throughout the intervention period, reminder messages regarding completion of assigned tasks will also be sent to all participants. The counseling sessions will be conducted by a trained MSc student in Midwifery Counseling under the supervision of a PhD in Reproductive Health. All participants will complete a demographic and obstetric characteristics questionnaire before the intervention. In addition, the Persian version of the 78-item Multidimensional Sexual Self-Concept Questionnaire (MSSCQ) will be completed before the intervention, immediately after the intervention, and four weeks after completion of the counseling sessions. Intervention 3: Control Group: Participants in the control group will receive routine care as provided by health centers and outpatient clinics. Following completion of the study, the educational intervention materials will be offered to participants in the control group for ethical considerations. 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 This study involves sexual counseling, and confidentiality will be strictly maintained.
public Narjes Salehi Derakhtanjani
Department of Midwifery Counseling, Razi School of Nursing and Midwifery, Kerman University of Medical Sciences Campus, Haft Bagh Alavi Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5180 narjes.salehi1380@gmail.com Kerman University of Medical Sciences scientific Hadis Shahrahmani
Department of Midwifery Counseling, Razi School of Nursing and Midwifery, Kerman University of Medical Sciences Campus, Haft Bagh Alavi Highway, Kerman, Iran.
Kerman Iran (Islamic Republic of) 7616910002 +98 34 3132 5180 hadis.shahrahmani@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Diagnosis of polycystic ovary syndrome based on the presence of at least two of the Rotterdam diagnostic criteria Married women Iranian nationality Aged 18–45 years Having a stable relationship for at least 6 months Being sexually active Having a monogamous spouse Ability to read and write Access to a smartphone and Internet Providing informed consent to participate in the study 18 years 45 years Female Presence of active systemic medical disorders, including cardiovascular, renal, or hepatic diseases, and endocrine disorders other than polycystic ovary syndrome (PCOS) Presence of psychiatric disorders Presence of sexual dysfunction Use of medications that affect sexual function Participation in other psychological or psychiatric interventions, or receipt of sexual counseling within the past 6 months Substance abuse, including alcohol, narcotics, and psychoactive substances Pregnancy or breastfeeding Presence of an active divorce proceeding in judicial authorities Experience of major stressful life events during the past 6 months (e.g., accident, bereavement, or other significant stressors) E28.2 Polycystic ovarian syndrome Other Other Other Intervention Group 1 (Online Intervention Group): Participants in the online intervention group will receive BETTER model-based sexual counseling in four weekly individual sessions, each lasting 60–90 minutes. The content of the sessions will be developed according to the six stages of the BETTER model.In the online intervention group, participants will receive four weekly sexual counseling sessions through online chat via a private page on an accessible domestic or international messaging platform. Educational materials will be delivered in the form of audio files, video files, and written text, with the possibility of real-time voice communication with the researcher.A reminder text message will be sent one day before each session. Participants will be asked to be online at the scheduled time, ask their questions, and receive the required counseling from the researcher. To ensure adherence to the intervention and engagement with the educational content, participants will be asked questions about the topics covered in the previous session before the content of each new session is delivered, and these will be reviewed at the beginning of the session. Reminder messages regarding completion of assigned tasks will also be sent throughout the intervention period.The counseling sessions will be conducted by a trained MSc student in Midwifery Counseling under the supervision of a PhD in Reproductive Health. All sessions will be conducted with full respect for participant privacy and confidentiality. All participants will complete a demographic and obstetric characteristics questionnaire before the intervention. In addition, the Persian version of the 78-item Multidimensional Sexual Self-Concept Questionnaire (MSSCQ) will be completed before the intervention, immediately after the intervention, and four weeks after completion of the counseling sessions. Intervention Group 2 (Face-to-Face Intervention Group): Participants in the face-to-face intervention group will receive BETTER model-based sexual counseling in four weekly individual sessions, each lasting 60–90 minutes, delivered in person. The content of the sessions will be identical in both the face-to-face and online groups and will be designed based on the six stages of the BETTER model.A reminder text message will be sent one day before each session. Sessions will be conducted at the data collection site in a private room with appropriate lighting and temperature, ensuring full participant confidentiality.Throughout the intervention period, reminder messages regarding completion of assigned tasks will also be sent to all participants. The counseling sessions will be conducted by a trained MSc student in Midwifery Counseling under the supervision of a PhD in Reproductive Health. All participants will complete a demographic and obstetric characteristics questionnaire before the intervention. In addition, the Persian version of the 78-item Multidimensional Sexual Self-Concept Questionnaire (MSSCQ) will be completed before the intervention, immediately after the intervention, and four weeks after completion of the counseling sessions. Control Group: Participants in the control group will receive routine care as provided by health centers and outpatient clinics. Following completion of the study, the educational intervention materials will be offered to participants in the control group for ethical considerations. Total score on the Persian version of the 78-item Multidimensional Sexual Self-Concept Questionnaire. Timepoint: The Multidimensional Sexual Self-Concept Questionnaire will be completed at three time points: before the intervention, immediately after the intervention, and four weeks after the intervention. Method of measurement: Persian version of the 78-item Multidimensional Sexual Self-Concept Questionnaire. Kerman University of Medical Sciences Approved 2026-08-10 Ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences Campus, Haft Bagh Alavi Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)