Ex-Plissit Model Based Counseling on Sexual Function and Sexual Satisfaction
1 other identifier
interventional
40
1 country
1
Brief Summary
Aimed to determine the effect of sexual education based on the EX-PLISSIT model on sexual function and sexual satisfaction in women with multiple sclerosis. The present study was a pretest-posttest randomized controlled study. Conducted between June and August 2023 in Turkey. The participants were MS patients who were women 18-49 years old. The intervention (n = 20) and a control group (n = 20). The intervention group received sexual counseling based on the EX-PLISSIT model. The model consists of four levels. The levels are permission, limited information, specific suggestions and intensive therapy. Counseling was presented in six to eight sessions according to the women's sexual problems. The Female Sexual Function Index (FSFI) and the New Sexual Satisfaction Scale were used to measure the sexual function and sexual satisfaction of the participants. Data were analyzed using the Statistical Package for the Social Sciences (SPSS) version 21. P values below 0.05 were considered statistically significant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Shorter than P25 for not_applicable
1 active site
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 Start
First participant enrolled
May 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedFirst Submitted
Initial submission to the registry
December 27, 2023
CompletedFirst Posted
Study publicly available on registry
January 10, 2024
CompletedJanuary 10, 2024
January 1, 2024
4 months
December 27, 2023
January 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The Female Sexual Function Index (FSFI) Score
The Female Sexual Function Index 19-item self-report questionnaire evaluating the sexual functions of female patients. The questions are regarding women's sexual feelings and responses during the last four weeks. Accordingly, the highest score that can be obtained from the scale is 36.0 and the lowest score is 2.0.
8 weeks
Secondary Outcomes (1)
New Sexual Satisfaction Scale (NSSS) Score
8 weeks
Study Arms (2)
Intervention Group
OTHERSexual counseling, based on the extended (EX-PLISSIT) model was offered to women for 6-10 weeks (until a solution was achieved). All interventions must begin with "Permission." Each stage of "Limited Information", "Special Recommendation" and "Intensive Therapy" is supported by "Allowing". Thus, the interaction between counselors and clients is improved
Control Group
NO INTERVENTIONNo intervention pretest posttest
Interventions
The EX-PLISSIT model is done in a cyclical manner. In other words, it is an interactive and repetitive model. All interventions must begin with "Permission." Each stage of "Limited Information", "Special Recommendation" and "Intensive Therapy" is supported by "Allowing". Thus, the interaction between counselors and clients is improved (Taylor and Davis 2006; Punjani and Papathanasoglu, 2019).
Eligibility Criteria
You may qualify if:
- Being between the reproductive age range of 18-49
- Being sexually active for at least 1 year
- MS diagnosis must have been confirmed at least 6 months ago
- EDSS scale score \<7
- Be willing to participate
- Not having any chronic disease (thyroid problems, diabetes mellitus, cardiovascular diseases, etc.)
- Being able to speak and understand Turkish
You may not qualify if:
- Pregnant or breastfeeding women
- Those who score 16 and above according to the BECK depression scale
- Women under treatment for sexual dysfunction
- Women with inadequate cognitive levels
- Having an MS attack within the last month
- Alcohol and drug addiction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vesile KOÇAK
Konya, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Vesile Kocak
Necmettin Erbakan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
December 27, 2023
First Posted
January 10, 2024
Study Start
May 10, 2023
Primary Completion
August 30, 2023
Study Completion
September 30, 2023
Last Updated
January 10, 2024
Record last verified: 2024-01