MS (Multiple Sclerosis)NCT06199219
Ex-Plissit Model Based Counseling on Sexual Function and Sexual Satisfaction
A study testing Sexual counseling, based on the extended (EX-PLISSIT) in people with MS (Multiple Sclerosis) and Sexual Dysfunctions, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- MS (Multiple Sclerosis), Sexual Dysfunctions, Counseling
- What is being tested?
- Sexual counseling, based on the extended (EX-PLISSIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- MS (Multiple Sclerosis), Sexual Dysfunctions, Counseling
- Being tested
- Sexual counseling, based on the extended (EX-PLISSIT)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual counseling, based on the extended (EX-PLISSIT)Other
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Other | 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 Receives: Other: Sexual counseling, based on the extended (EX-PLISSIT) |
| Control Group | No intervention | No intervention pretest posttest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
New Sexual Satisfaction Scale (NSSS) Score
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start10 May 2023
- Primary completion30 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MS (Multiple Sclerosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vesile Koak, Necmettin Erbakan University
- Investigators
- Vesile Kocak, Study chair, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199219
- Sponsor's protocol ID
- 21122023
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex-Plissit Model Based Counseling on Sexual Function and Sexual Satisfaction in Women With Multiple Sclerosis: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06199219
- Acronym / sponsor ID
- 21122023
- Conditions
- MS (Multiple Sclerosis), Sexual Dysfunctions, Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Other | Other: Sexual counseling, based on the extended (EX-PLISSIT)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 |
| Control Group | No intervention | –No intervention pretest posttest |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Intervention Group |
Primary outcome
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.
1 secondary outcome
New Sexual Satisfaction Scale (NSSS) Score
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vesile Kocak study chair
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual counseling, based on the extended (EX-PLISSIT) in people with MS (Multiple Sclerosis) and Sexual Dysfunctions, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Female Sexual Function Index (FSFI) Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.