- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07283146
The Effect of EX-PLISSIT Model-Based Sexual Counseling in Postmenopausal Women
The Effect of EX-PLISSIT Model-Based Sexual Counseling on Perceptions of Sexuality, Sexual Quality of Life, and Sexual Satisfaction in Postmenopausal Women
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Yozgat, Turkey (Türkiye), 66300
- Akdagmadeni Public Education Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
|
|
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Experimental: Counseling Group
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Sexual Life Quality
Time Frame: Baseline, 1 month later and 3 months later
|
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.
|
Baseline, 1 month later and 3 months later
|
|
Change in sexual satisfaction
Time Frame: Baseline, 1 month later and 3 months later
|
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.
|
Baseline, 1 month later and 3 months later
|
|
Change in sexuality perception
Time Frame: Baseline, 1 month later and 3 months later
|
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.
|
Baseline, 1 month later and 3 months later
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 18/242
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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