The Effect of EX-PLISSIT Model-Based Sexual Counseling in Postmenopausal Women
1 other identifier
interventional
74
0 countries
N/A
Brief Summary
The study will be conducted in two groups as counseling and control. Participants will be approached at the Public Education Center. After postmenopausal women are evaluated according to eligibility criteria, those who are eligible will be informed about the research and written informed consent will be obtained from those who agree. Random assignment of women to the study groups will be carried out using randomization. This study aimed to determine the effects of sexual counseling based on the EX-PLISSIT model on sexual quality of life, sexual satisfaction, and perceptions of sexuality in postmenopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2025
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2025
CompletedFirst Posted
Study publicly available on registry
December 15, 2025
CompletedStudy Start
First participant enrolled
December 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 17, 2026
December 15, 2025
December 1, 2025
7 months
December 2, 2025
December 2, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Change in Sexual Life Quality
The scale is easy to apply, 6-point Likert type, which individuals can answer on their own, and consists of 18 items. Each item is expected to be answered considering the sexual life in the last four weeks. Each item of the scale is scored between 1 and 6. The items of the scale are scored as "I totally agree"=1, "I strongly agree"=2, "I partially agree"=3, "I partially disagree"=4, "I strongly disagree"=5, "I strongly disagree"=6 and 1 Questions 5, 9, 13 and 18 are reverse coded. The range of points that can be obtained from the scale is between 18-108.
at the beginning of the study, 1 month later and 3 months later
Change in sexual satisfaction
VAS is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfied and a score of 0 pointed to no satisfied.
at the beginning of the study, 1 month later and 3 months later
Change in sexuality perception
Sexuality Perception Scale in Menopause The 12-item, 5-point Likert-type scale consists of two subdimensions: Perceptions Restricting Sexuality and Perceptions Related to the Continuation of Sexual Life. The minimum possible score on the scale is 12, and the maximum score is 60. Higher scores indicate more positive perceptions regarding sexuality during menopause.
at the beginning of the study, 1 month later and 3 months later
Study Arms (2)
Counseling Group
EXPERIMENTALControl Group
NO INTERVENTIONInterventions
Women in the experimental group will receive sexual counseling based on the EX-PLISSIT model. The steps to be followed in accordance with this model are as follows: Session 1 Permission Limited Information Specific Suggestions IT - Intensive Therapy Session 2 At the beginning of the interview, the data collection forms will be re-administered, and the homework assigned in the first session will be discussed. The information needed by the woman, in line with her questions, will be provided within the steps of the EX-PLISSIT model: permission, limited information, specific suggestions, and, if necessary, intensive therapy. At the end of the second session, the women will be given an appointment for the final assessment to be conducted two months later. Session 3 At the beginning of the interview, the data collection forms will be administered for the last time, the woman's questions (if any) will be answered, and the session will be concluded.
Eligibility Criteria
You may qualify if:
- Postmenopausal, defined as having had no menstrual periods or vaginal bleeding in the last 12 months,
- Under 65 years of age,
- Married,
- Having entered menopause naturally,
- Able to understand, speak, and read Turkish.
You may not qualify if:
- Women with diagnosed conditions that may significantly affect sexual quality of life (such as diabetes, hypertension, heart disease, pulmonary diseases, cancer types, psychiatric disorders, or a history of neurological stroke),
- Women using medications known to negatively affect sexual function (including psychotropic drugs, cardiac and antihypertensive medications, anticonvulsants, opioids, antinarcotics, H2-receptor antagonists, and antihistamines),
- Those who have previously received or are currently receiving hormone replacement therapy,
- Those with a diagnosis of sexual dysfunction in themselves or their partners,
- Those who have experienced major stressful life events (such as an accident, trauma, or the death or severe illness of a close relative) within the three months prior to the study,
- Women with a serious impairment that affects their ability to complete data collection forms,
- Not willing to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Faculty of Nursing
Study Record Dates
First Submitted
December 2, 2025
First Posted
December 15, 2025
Study Start
December 15, 2025
Primary Completion (Estimated)
July 17, 2026
Study Completion (Estimated)
July 17, 2026
Last Updated
December 15, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share