- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Konya
-
Konya, Konya, Turecko (Türkiye)
- Selcuk University
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: control group
The control group will not receive any intervention.
They will only be given educational brochures.
|
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Measuring the impact of sexual counseling based on the EX PLISSIT model
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Measuring the impact of sexual counseling based on the EX PLISSIT model
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- DECISION 02-2026/43
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .