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Comparison the Effect of BETTER Sexual Counseling Model (in-person and online) on Sexual Self-Concept in Women with Polycystic Ovary Syndrome

Protocol summary

Study aim
Determining and Comparing the Effect of the BETTER Sexual Counseling Model Delivered Face to Face and Remotely on the Sexual Self Concept of Women with Polycystic Ovary Syndrome Referred to Health and Medical Centers in Kerman in 1405
Design
A randomized controlled clinical trial with three parallel groups and a blinded data analyst, including 63 participants, using block randomization with blocks of nine. The randomization sequence will be generated using the online Sealed Envelope system.
Settings and conduct
This trial will be conducted in comprehensive health service centers and specialized women’s and midwifery offices in Kerman. Eligible participants will be randomly assigned to three groups: face to face counseling, remote counseling, and control. The two intervention groups will receive four weekly counseling sessions based on the BETTER model, while the control group will receive usual care. The data analyst will be blinded to group allocation.
Participants/Inclusion and exclusion criteria
Married women aged 18 to 45 years with polycystic ovary syndrome diagnosed by at least two Rotterdam criteria, a stable marital relationship and active sexual life, who are literate, have smartphone and internet access, and provide written informed consent.Exclusion criteria: Active systemic or endocrine diseases other than polycystic ovary syndrome, psychiatric disorders, sexual dysfunction, use of medications affecting sexual function, concurrent sexual counseling or psychological or psychiatric interventions, pregnancy or breastfeeding, and alcohol or drug use.
Intervention groups
The face to face group will receive BETTER model based face to face counseling. The remote group will receive the same counseling online. The control group will receive usual care from health and medical centers and offices.
Main outcome variables
ُSexual self concept

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260602069613N1
Registration date: 2026-09-10, 1405/06/19
Registration timing: prospective

Last update: 2026-09-10, 1405/06/19
Update count: 0
Registration date
2026-09-10, 1405/06/19
Registrant information
Name
Narjes Salehi Derakhtanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5180
Email address
nsalehi@kmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-18, 1405/06/27
Expected recruitment end date
2027-02-14, 1405/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of BETTER Sexual Counseling Model (in-person and online) on Sexual Self-Concept in Women with Polycystic Ovary Syndrome
Public title
Comparison the Effect of BETTER Sexual Counseling Model (in-person and online) on Sexual Self-Concept in Women with Polycystic Ovary Syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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)
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 63
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences Campus, Haft Bagh Alavi Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616910002
Approval date
2026-08-10, 1405/05/19
Ethics committee reference number
IR.KMU.REC.1405.288

Health conditions studied

1

Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Other

2

Description
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.
Category
Other

3

Description
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.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive health service centers, women’s and midwifery offices and clinics in Kerman
Full name of responsible person
Narjes Salehi Derakhtanjani
Street address
Department of Midwifery Counseling, Razi School of Nursing and Midwifery, Kerman University of Medical Sciences Campus, Haft Bagh Alavi Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616910002
Phone
+98 34 3132 5180
Email
narjes.salehi1380@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Hamid Sharifi
Street address
Vice Chancellor for Research and Technology, Beginning of Ibn Sina Street, Somayeh Crossroads (Tahmasb Abad), Kerman, Iran
City
kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3821
Email
sharifihami@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Narjes Salehi Derakhtanjani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery Counseling, Razi School of Nursing and Midwifery, Kerman University of Medical Sciences Campus, Haft Bagh Alavi Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5180
Email
narjes.salehi1380@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hadis Shahrahmani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery Counseling, Razi School of Nursing and Midwifery, Kerman University of Medical Sciences Campus, Haft Bagh Alavi Highway, Kerman, Iran.
City
Kerman
Province
Kerman
Postal code
7616910002
Phone
+98 34 3132 5180
Email
hadis.shahrahmani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Narjes Salehi Derakhtanjani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery Counseling, Razi School of Nursing and Midwifery, Kerman University of Medical Sciences Campus, Haft Bagh Alavi Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616910009
Phone
+98 34 3132 5180
Email
narjes.salehi1380@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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