- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07559916
THE EFFECT OF SEXUAL COUNSELING BASED ON THE EXPLISSIT MODEL ON SEXUAL FUNCTION, MARITAL ADJUSTMENT, AND QUALITY OF SEXUAL LIFE IN POSTMENOPAUSAL WOMEN
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Konya
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Konya, Konya, Turkey (Türkiye)
- Selcuk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
The control group will not receive any intervention.
They will only be given educational brochures.
|
|
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Experimental: experimental group
The group that received sexual education 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measuring the impact of sexual counseling based on the EX PLISSIT model
Time Frame: two months
|
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 |
two months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measuring the impact of sexual counseling based on the EX PLISSIT model
Time Frame: two months
|
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. |
two months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1038/s41598-026-43203-6. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DECISION 02-2026/43
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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