NCT07283146

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

65
Monitor

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Dec 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Study Progress58%
Dec 2025Jul 2026

First Submitted

Initial submission to the registry

December 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2026

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

December 2, 2025

Last Update Submit

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

EXPERIMENTAL
Other: EX-PLISSIT Model-Based Sexual Counseling

Control Group

NO INTERVENTION

Interventions

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.

Counseling Group

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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