NCT07559916

Brief 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Feb 2026Jul 2026

Study Start

First participant enrolled

February 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 23, 2026

Last Update Submit

April 23, 2026

Conditions

Keywords

SexualityEx-PLISSIT MODELPostmenopausal

Outcome Measures

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) It was developed by Rosen et al. as a multidimensional scale comprising 19 items to evaluate 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 Outcomes (1)

  • Measuring the impact of sexual counseling based on the EX PLISSIT model

    two months

Study Arms (2)

control group

NO INTERVENTION

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

experimental group

EXPERIMENTAL

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

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

Interventions

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.

experimental group

Eligibility Criteria

Age43 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 scale,

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, Turkey (Türkiye)

Location

Related Publications (1)

  • 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. Dalvand, R., Otogara, M., Shayan, A., Kazemi, F., & Haghighi, M. (2024). The impact of couple-focused counseling based on the EX-Plissit model on the sexual self-concept of infertile couples. Daneshfar, F., Behboodi-Moghadam, Z., Khakbazan, Z., Nabavi, S. M., Nayeri, N. D., Ghasemzadeh, S., & Montazeri, A. (2017). The influence of Ex-PLISSIT (extended permission, limited information, specific suggestions, intensive therapy) model on intimacy and sexuality of married women with multiple sclerosis. Sexuality and Disability, 35(4), 399-414. Demirtaş, F. A., Fırat, B., & Sahin, N. (2022). Menopoz ve cinsel yaşam: Sistematik derleme. Androloji Bülteni (Andrology Bullettin), 24(2). Engin B, Aydın Kartal Y. (2020). Menopozal Semptomlar ile Başetmede Kullanılan Tamamlayıcı ve Alternatif Tedavi Yaklaşımları. Sağlık Profesyonelleri Araştırma Dergisi., 2(2), 80-87. 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. Gazibara T, Nurkovic S, Kovacevic N, Kurtagic I, Rancic B, Radovanovic S, & Dotlic J. Factors associated with sexual quality of life among midlife women in Serbia. Quality of Life Research. 2017;26(10):2793-2804. Kahyaoğlu Süt, H., & Küçükkaya, B. (2018). Premenopoz, perimenopoz ve postmenopoz dönem kadınlarında cinsel yaşam kalitesi. Kadın Sağlığı Hemşireliği Dergisi, 4(1), 51-68. Kaplan, E., & Zeyneloğlu, S. (2018). Geri çekme yönteminin kadınların cinsel doyumları ve evlilik uyumlarına etkisinin belirlenmesi. Necmettin Erbakan Üniversitesi Sağlık Bilimleri Fakültesi Dergisi, 1, 10-17. Koçak, V., Koçak, A. T., Arslan, S., & Uca, A. U. (2026). Enhancing Sexual Health in Multiple Sclerosis: A Randomized Controll

    BACKGROUND

MeSH Terms

Conditions

CoitusSexuality

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Doctor

Study Record Dates

First Submitted

April 23, 2026

First Posted

April 30, 2026

Study Start

February 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations