Ex-Plissit Model Based Counseling on Sexual Function and Sexual Satisfaction

January 9, 2024 updated by: Vesile Koak, Necmettin Erbakan University

Ex-Plissit Model Based Counseling on Sexual Function and Sexual Satisfaction in Women With Multiple Sclerosis: A Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Within the scope of this research, sexual counseling, based on the extended (EX-PLISSIT) model was offered to women for 6-10 weeks (until a solution was achieved). The EX-PLISSIT model is based on the core concepts of the PLISSIT model. The PLISSIT model is an effective, convenient and cost effective counseling method. This model was designed by Annon (1976) and includes the stages permission, limited ınformation, specific recommendations and intensive therapy. It is known that the PLISSIT model is effective for SD. The PLISSIT Model has been updated and expanded because it offers one-way, passive interaction. While counseling is linear in the PLISSIT model, it is feedback-oriented in the EX-PLISSIT model. This is one of the reasons why the EX-PLISSIT model is superior to the PLISSIT model. Unlike PLISSIT's linear mode; 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. While in the PLISSIT model, a direct transition can be made from one step to another, in the EX-PLISSIT model, the permission stage is at the center of the other stages and techniques such as review, and examination are used to increase the client's self-awareness. The EX-PLISSIT model is a practical guide for nursing research and practice.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey
        • Vesile KOÇAK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention Group

Sexual 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
Other: Sexual counseling, based on the extended (EX-PLISSIT)
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).
No Intervention: Control Group
No intervention pretest posttest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Female Sexual Function Index (FSFI) Score
Time Frame: 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
New Sexual Satisfaction Scale (NSSS) Score
Time Frame: 8 weeks
The New Sexual Satisfaction Scale (NSSS) was developed by Štulhofer et al. (2010), and the psychometric properties of the Turkish form were examined by Tuğut (2016). Turkish NSSS is a valid and reliable measurement tool to evaluate sexual satisfaction in Turkish women.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Necmettin Erbakan University

Investigators

  • Study Chair: Vesile Kocak, Necmettin Erbakan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2023

Primary Completion (Actual)

August 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

December 27, 2023

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21122023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on MS (Multiple Sclerosis)

Clinical Trials on Sexual counseling, based on the extended (EX-PLISSIT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe