Protocol summary
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Study aim
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Evaluate the effects of mindfulness-based sexual counseling, virtual reality (VR), and cognitive-behavioral therapy (CBT) on sexual function, quality of life, and sexual health literacy in infertile women with polycystic ovary syndrome (PCOS).
Compare sexual function between intervention and control groups, assess differences in sexual quality of life at various time points, evaluate sexual health literacy in both groups, and determine the relative effectiveness of these methods.
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Design
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Randomized, parallel-group clinical trial conducted in Kashan health centers to assess the effects of mindfulness-based sexual counseling, VR, and CBT on sexual function, quality of life, and literacy in PCOS women. Participants are convenience-sampled and randomly allocated using block randomization. Blinding participants is not feasible.
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Settings and conduct
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Parallel randomized trial in Kashan health centers. Participants are convenience-sampled and assigned using block randomization to intervention (8 combined in-person/online sessions) and control groups. Assessments with FSFI, SQOL-F, and SHELA questionnaires occur at baseline and one month post-intervention. Control group receives no intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Married women aged 18-45 with infertility and PCOS, no psychiatric disorders, no medications affecting sexual function, minimum one year of infertility, sexual activity, and not pregnant or undergoing infertility treatment.
Exclusion criteria:
Unwillingness to continue, pregnancy during the study, or non-compliance with intervention.
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Intervention groups
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Receiving mindfulness-based sexual counseling, virtual reality interventions, and CBT.
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Main outcome variables
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Sexual function (measured by FSFI), sexual quality of life (assessed by SQOL-F), and sexual health literacy (evaluated by SHELA).
General information
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Reason for update
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Change in sample size
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Acronym
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MVR-CBT-INFERTILITY
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IRCT registration information
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IRCT registration number:
IRCT20250711066445N1
Registration date:
2025-07-20, 1404/04/29
Registration timing:
prospective
Last update:
2026-10-14, 1405/07/22
Update count:
1
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Registration date
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2025-07-20, 1404/04/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-09-06, 1404/06/15
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Expected recruitment end date
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2026-03-06, 1404/12/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Evaluating the effects of new counselling methods on sexual health and quality of life in infertile women with polycystic ovary syndrome
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
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.
Exclusion criteria:
Becoming pregnant during the study
Failure to perform the intervention regularly and correctly
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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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.
Ethics committees
1
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Ethics committee
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Approval date
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2025-07-09, 1404/04/18
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Ethics committee reference number
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IR.MODARES.REC.1404.055
Health conditions studied
1
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Description of health condition studied
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Polycystic Ovary Syndrome (PCOS) in infertile women
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Sexual function
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Timepoint
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Baseline, 1 month post-intervention, and 2 months post-intervention
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Method of measurement
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Sexual function will be measured using the Female Sexual Function Index (FSFI).
2
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Description
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Sexual quality of life
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Timepoint
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Baseline, 1 month post-intervention, and 2 months post-intervention
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Method of measurement
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Sexual quality of life will be measured using the Sexual Quality of Life Questionnaire for Women (SQOL-F).
3
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Description
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Sexual health literacy
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Timepoint
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Baseline, 1 month post-intervention, and 2 months post-intervention
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Method of measurement
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Sexual health literacy will be measured using the Sexual Health Literacy for Adults (SHELA) assessment tool.
Secondary outcomes
1
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Description
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No secondary outcome variables identified; the study focuses solely on primary outcomes
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Timepoint
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Not applicable
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Method of measurement
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Not applicable
Intervention groups
1
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Description
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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.
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Category
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Behavior
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Description
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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.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tarbiat Modares university
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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The course access begins 12 months after the publication of results.
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To whom data/document is available
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Researchers employed at academic and scientific institutions
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Under which criteria data/document could be used
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Use in review studies
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From where data/document is obtainable
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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.
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What processes are involved for a request to access data/document
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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.
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Comments
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