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Sexual and Reproductive HealthNCT07559916

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

A study testing Group receiving sexual counseling based on the EX PLISSIT model. in people with Sexual and Reproductive Health and Menopausal and Postmenopausal Women, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 43 to 55 years, women onlyHealthy volunteers can take part
What is being tested?
Group receiving sexual counseling based on the EX PLISSIT model.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2026to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 43 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Selcuk University

    Konya, Konya

Other trials in Turkey (Türkiye)

About this study

Official title: THE EFFECT OF SEXUAL COUNSELING BASED ON THE EXPLISSIT MODEL ON SEXUAL FUNCTION, MARITAL ADJUSTMENT, AND QUALITY OF SEXUAL LIFE IN POSTMENOPAUSAL WOMEN: A RANDOMIZED CONTROLLED STUDY

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

Being tested
Group receiving sexual counseling based on the EX PLISSIT model.
Keywords
Sexuality, Ex-PLISSIT MODEL, Postmenopausal
Medical subject headings
Coitus, Sexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT07559916
Study groupRoleWhat they receive
control groupNo interventionThe control group will not receive any intervention. They will only be given educational brochures.
experimental groupExperimentalThe group that received sexual education based on the EX PLISSIT model
Receives: Other: Group receiving sexual counseling based on the EX PLISSIT model.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: two months

Secondary outcomes (1)
  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.

    Measured: two months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2026
  2. Study start1 Feb 2026
  3. Primary completion1 May 2026
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07559916
Sponsor's protocol ID
DECISION 02-2026/43
Status last verified
Oct 2026
First submitted
23 Apr 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

Questions about this trial

What is this clinical trial studying?

A study testing Group receiving sexual counseling based on the EX PLISSIT model. in people with Sexual and Reproductive Health and Menopausal and Postmenopausal Women, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measuring the impact of sexual counseling based on the EX PLISSIT model (time frame: two months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07559916, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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