ClinicalTrials.gg
Enrolling by invitationNCT07559916Updated Oct 21, 2026

THE EFFECT OF SEXUAL COUNSELING BASED ON THE EXPLISSIT MODEL ON SEXUAL FUNCTION, MARITAL ADJUSTMENT, AND QUALITY OF SEXUAL LIFE IN POSTMENOPAUSAL WOMEN

An interventional study of Group receiving sexual counseling based on the EX PLISSIT model. in Sexual and Reproductive Health and Menopausal and Postmenopausal Women, sponsored by Karamanoğlu Mehmetbey University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to female participants aged 43 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Karamanoğlu Mehmetbey University · Not applicable, Interventional, and Supportive care

Updated Oct 21, 2026Study completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
43 Years to 55 Years
Sex
Female
01

Study summary

Sexual health is not merely about sexual dysfunction, but a complex, diverse, and multifaceted natural process encompassing a wide range of aspects of human life, extending from childhood to old age. Quality of sexual life refers to an individual's satisfaction with their sexual life. Due to increased life expectancy, women spend more than a third of their lives in the postmenopausal period. Contrary to expectations, sexuality becomes increasingly important for women in the postmenopausal period. The postmenopausal period, following menopause, brings about vasomotor, psychological, and urogenital changes and complaints, as well as various health problems. These changes and complaints can impair sexual function, sexual satisfaction, and marital harmony, negatively impacting the quality of sexual life. The literature indicates that sexual satisfaction is one of the most important factors affecting marital harmony, and that sexual dissatisfaction diminishes positive emotions and intimacy within marriage. The postmenopausal period has a significant impact not only on life expectancy but also on couples' sexual health and marital harmony. However, the assessment of this issue by healthcare personnel is often neglected. Assessing patients' sexual health and concerns about sexuality is an important part of the professional nursing role and holistic care. For this purpose, it is stated that participation in special training programs aimed at assessing patient sexuality and the use of models that will provide guidance can be beneficial . The use of professional sexual diagnostic models by nurses in assessing patient sexuality will lead to a healthier and more effective questioning and evaluation of sexuality. The PLISSIT and EX-PLISSIT models are commonly used by nurses in primary care to address sexual health needs and concerns. The PLISSIT model consists of four therapeutic stages: Permission, Limited Information (LI), Specific Suggestions (SS), and Intensive Therapy (IT). As the intervention stages of the PLISSIT model progress, more comprehensive knowledge, training, and skills are required. Ex-PLISSIT is an expanded version of the PLISSIT model, with the permission stage being central. One cannot proceed to the next stage without completing the permission stage

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Conditions studied

  • Sexual and Reproductive Health
  • Menopausal and Postmenopausal Women

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Keywords

  • Sexuality
  • Ex-PLISSIT MODEL
  • Postmenopausal
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In context

Sexuality

130 studies on the registry are indexed under Sexuality; 26 are open to participants now.

This study's planned enrollment of 86 is above the median of 75 across 79 interventional studies indexed under Sexuality.

Browse Sexuality studies →

Lead sponsor

Karamanoğlu Mehmetbey University is the lead sponsor of 69 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
43 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being sexually active
  • Living with a spouse/partner
  • Having at least a primary school diploma
  • Being in the period
  • Agreeing to participate in the study
  • Having entered menopause naturally
  • Scoring ≤26.55 on the FSFI scal

Exclusion criteria

Exclusion Criteria:

  • Being on Hormone Replacement Therapy (HRT) and not having discontinued HRT treatment at least six months prior to the study
  • Having undergone surgical menopause
  • Not having entered menopause at an early or late age (over 40 and under 55 years of age)
  • Having a chronic systemic disease and/or a psychiatric health problem
  • Having a disability that makes communication difficult, such as hearing or language problems
  • Having received any sexual counseling before the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
86 participants (estimated)

Study arms

  • No intervention
    control group

    The control group will not receive any intervention. They will only be given educational brochures.

  • Experimental
    experimental group

    The group that received sexual education based on the EX PLISSIT model

    Other: Group receiving sexual counseling based on the EX PLISSIT model.

Interventions

  • OtherGroup receiving sexual counseling based on the EX PLISSIT model.

    Appointments will be scheduled for the women in the intervention group to meet at a convenient time and in a suitable environment at the hospital. Sexual counseling within the intervention group will be planned and implemented according to the 4 stages of the EX-PLISSIT model, focusing on the patients' sexual health. Counseling sessions will be conducted by a nurse specializing in sexuality (first author) with a sexual counseling certificate, under the direct supervision of a faculty member specializing in obstetrics and gynecology nursing (second author). The intervention consisted of 4 counseling sessions, each lasting 60-90 minutes, once a week for four weeks. All sessions will be conducted face-to-face and individually in a private room.

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What researchers measure

Primary outcomes

  1. Measuring the impact of sexual counseling based on the EX PLISSIT model

    After sexual counseling based on the EX PLISSIT model, the Female Sexual Function Index (FSFI) scale were administered to women in the experimental and control groups via face-to-face interviews. The administration time for each scale varied between 15 and 20 minutes. Changes in the Female Sexual Function Index (FSFI) scale were measured two months after sexual counseling based on the EX PLISSIT model. Female Sexual Function Index (FSFI) This is a 19-item multidimensional scale for evaluating female sexual function. The scale includes six subheadings, desire, arousal, lubrication, orgasm, satisfaction, and pain. Each title was scored between 0 or 1 and six. The lowest and highest scores are 2 and 36, respectively. Higher scores indicated better sexual function. The cut-off value of the scale was 26.55. A total FSFI score of ≤26.55, it indicates sexual dysfunction

    Time frame: two months

Secondary outcomes

  1. Measuring the impact of sexual counseling based on the EX PLISSIT model

    After sexual counseling based on the EX PLISSIT model, the Sexual Quality of Life-Female (SQoL-F) scale were administered to women in the experimental and control groups via face-to-face interviews. The administration time for each scale varied between 15 and 20 minutes. Changes in the Female Sexual Quality of Life (SQoL-F) scales were measured two months after sexual counseling based on the EX PLISSIT model. Sexual Quality of Life-Female (SQoL-F): It is a 6-point Likert-type scale consisting of 18 items. Respondents consider their sexual life over the past four weeks. Scores range from 18 to 108. Higher scores indicate better sexual quality of life.

    Time frame: two months

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Study locations

1 site
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References and documents

Publications

  • Zahan, A., Sharma, N. K., Islam, M. N., Sen, S., & Bhowmik, K. R. (2025). Menopausal Symptoms and Coping Strategies among Women of 40-60 Years Age-Group: A Tertiary Care Hospital Experience from Bangladesh. Community Based Medical Journal, 14(1), 54-60.
  • World Health Organization. (2017). Sexual health and its linkages to reproductive health: An operational approach. Accessed 02. 05. 2020, https://www.who.int/publications/i/item/97892415 49998.
  • Üstgörül, S., Yanıkkerem, E., & Göker, A. (2025). Investigation of the Effect of Counseling Given to Postpartum Women with the EX-PLISSIT Model on Sexual. The Family Journal, 10664807241312203.
  • Taylor B, Davis S. Using the extended PLISSIT model to address sexual healthcare needs. Nurs Stand. 2006 Nov 22-28;21(11):35-40. doi: 10.7748/ns2006.11.21.11.35.c6382. PubMed 17165482 ↗
  • Shami M, Montazeri A, Faezi ST, Behboodi Moghadam Z. The Effect of Sexual Counseling Based on EX-PLISSIT Model on Improving the Sexual Function of Married Women with Systemic Lupus Erythematosus: A Randomized Controlled Trial. Sex Disabil. 2023;41(2):451-466. doi: 10.1007/s11195-023-09776-0. Epub 2023 Feb 27. PubMed 37168977 ↗
  • Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597. PubMed 10782451 ↗
  • Nazari, S., Keramatkar, M., Moghdehipanah, H., & Olfati, F. (2023). The effect of ex-PLISSIT model on sexual satisfaction in women with multiple sclerosis. Sexuality and Disability, 41(2), 467-477.
  • Mohammadi Z, Maasoumi R, Vosoughi N, Eftekhar T, Soleimani M, Montazeri A. The effect of the EX-PLISSIT model-based psychosexual counseling on improving sexual function and sexual quality of life in gynecologic cancer survivors: a randomized controlled clinical trial. Support Care Cancer. 2022 Nov;30(11):9117-9126. doi: 10.1007/s00520-022-07332-8. Epub 2022 Aug 23. PubMed 35997810 ↗
  • Mahmoodi Dangesaraki M, Maasoumi R, Hamzehgardeshi Z, Kharaghani R. Effect of the EX-PLISSIT model on sexual function and sexual quality of life among women after hysterectomy: a randomised controlled trial. Sex Health. 2019 Jun;16(3):225-232. doi: 10.1071/SH18107. PubMed 31064641 ↗
  • Koçak, V., Koçak, A. T., Arslan, S., & Uca, A. U. (2026). Enhancing Sexual Health in Multiple Sclerosis: A Randomized Controlled Trial of EX-PLISSIT Counseling. Sexuality and Disability, 44(1), 4.
  • Herbenick D, Reece M. Development and validation of the female genital self-image scale. J Sex Med. 2010 May;7(5):1822-30. doi: 10.1111/j.1743-6109.2010.01728.x. Epub 2010 Mar 3. PubMed 20233278 ↗
  • Gazibara T, Nurkovic S, Kovacevic N, Kurtagic I, Rancic B, Radovanovic S, Milosevic B, Terzic M, Dotlic J. Factors associated with sexual quality of life among midlife women in Serbia. Qual Life Res. 2017 Oct;26(10):2793-2804. doi: 10.1007/s11136-017-1608-3. Epub 2017 Jun 3. PubMed 28580495 ↗
  • Fattahi, M., Masoumi, S. Z., Kazemi, F., & Ahmadpanah, M. (2023). The effect of couple-centered counseling based on EX-PLISSIT model on the sexual function of couples during pregnancy: a randomized controlled trial. Nurs Midwifery Stud, 12(4), 213-220.
  • Dalvand R, Otogara M, Shayan A, Kazemi F, Haghighi M. The impact of couple-focused counseling based on the Ex-PLISSIT model on the sexual self-concept of infertile couples: a randomized trial. Sci Rep. 2026 May 7;16(1):21034. doi: 10.1038/s41598-026-43203-6. PubMed 42098181 ↗
  • Annon, J.S. (1976). The PLISSIT model: a proposed conceptual scheme for the behavioral treatment of sexual problems. Journal of Sex Education, 4(6), 81-88.
  • Altunbaş, N., & Gölbaşı, Z. (2024). The effect of sex education and counseling based on the ex-plissit model on sexual life in primigravidas. Clinical and Experimental Health Sciences, 14(2), 367-376.

Individual participant data

Plan to share: No

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Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2026 to primary completion in May 2026, 3 months.

Of 54 non-industry interventional studies with no phase under Sexuality, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 32. This study's 3 months is below that.

Counting every sponsor, half of 54 studies reached it within 12 months; a quarter within 6 and three quarters within 32.

Completion moved once since we started tracking on Sep 25, 2026: Jul 2026 → Dec 2026, on Oct 21, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2026
First posted
Apr 30, 2026
StartActual
Feb 1, 2026
Primary completionActual
May 1, 2026
CompletionEst.
Dec 1, 2026was Jul 2026
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Study completion
Jul 1, 2026→Dec 1, 2026
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    Study completion Jul 1, 2026→Dec 1, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07559916
Lead sponsor
Karamanoğlu Mehmetbey University
Responsible party
Serap Kırıcı (Lecturer Doctor, Karamanoğlu Mehmetbey University) — Principal investigator
First posted
Apr 30, 2026
Start date
Feb 1, 2026
Primary completion
May 1, 2026
Completion
Dec 1, 2026 (estimated)
Last update
Oct 21, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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