Multiple SclerosisNCT06004518
The Effect of Sexual Counseling With the PLISSIT Model on Sexual Function and Sexual Quality of Life in Women With Multiple Sclerosis: A Randomized Controlled Study
A study testing sexual counselling with PLISSIT model in people with Multiple Sclerosis and Female Sexual Dysfunction, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Multiple Sclerosis (MS) is a chronic neuroinflammatory disease of the central nervous system that is common in young ages and women. Plaques formed in MS can develop at any point in the brain and spinal cord, causing various symptoms and adversely affecting the patient's quality of life. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Multiple Sclerosis, Female Sexual Dysfunction
- What is being tested?
- sexual counselling with PLISSIT model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Dec 2024
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Women between the ages of 18-45,
- MS diagnosis is finalized,
- Able to communicate (speak and understand Turkish, no speech disorder),
- Have not had an attack for at least a month,
- Expanded Disability Status Scale (EDSS) score of 5.5 or less
- Those who score 3 or more on each item of the Multiple Sclerosis Intimacy and Sexuality Scale-15
Show all 11Show fewer
- Depression and anxiety scores of 3 and below according to the Patient Health Questionnaire-4
- Those who have a Fatigue Severity Scale score of 8 and below
- Does not have any additional chronic disease
- Having a sexual partner and
- Patients willing to participate in the study will be included in the study.
Who cannot join
- Women with urinary and stool incontinence problems, menopausal or premenopausal symptoms, a major psychiatric problem and using antidepressant medication, an inflammatory disease such as ankylosing spondylitis or rheumatoid arthritis, substance abuse and those who do not volunteer to participate in the study will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Multiple Sclerosis (MS) is a chronic neuroinflammatory disease of the central nervous system that is common in young ages and women. Plaques formed in MS can develop at any point in the brain and spinal cord, causing various symptoms and adversely affecting the patient's quality of life. Although not counted among the affected neurological systems, one of the most important symptoms experienced by MS patients is sexual dysfunction. Sexual dysfunction in MS may occur due to symptoms of MS such as spasticity, fatigue, and bladder problems, due to the presence of lesions affecting the neural pathways. The most common method used in the treatment of sexual dysfunction in women with MS is sexual counseling. The PLISSIT model is one of the most frequently used models by health professionals in sexual counseling and evaluation. PLISSIT stands for Permission, limited Information, Specific Suggestion and Intensive Therapy.
In this randomized controlled study, the long-term effect of sexual counseling given to female MS patients with the PLISSIT model on sexual function and sexual quality of life will be evaluated. The study is planned to be carried out between July 2023 and December 2024 in the MS and Demyenizing Diseases Unit of Istanbul University Istanbul Medical Faculty Hospital, Department of Neurology. The sample size was calculated as 86, 43 in the sexual counseling group and 43 in the control group, in the G*Power (v3.1.9.7) program using the power analysis method. The data of the study will be collected with the "Descriptive Information Form", "Multiple Sclerosis Intimacy and Sexuality Questionnaire-15", "Sexual Quality of Life Questionnaire for Women", "Patient Health Questionnaire-4" and "Fatigue Severity Scale" developed by the researchers.
Read more
The data will be analyzed in SPPS 28 package program. Number, percentage, mean, standard deviation, median and minimum-maximum values will be given in descriptive statistics. The t-test for independent samples/Mann-Whitney U test will be used to compare the mean score of the dependent variables of the two groups. Paired groups t-test/Wilcoxon test will be used in the comparison of each group within the group.
As a result of the research, it is possible to develop an alternative solution approach to the treatment of sexual problems of women with MS by comprehensively evaluating women with MS with sexual problems in line with the PLISSIT model, suggesting solutions, examining the long-term effectiveness of sexual counseling and evaluating the results with concrete, valid and reliable tools. will be provided.
Read the detailed description
Multiple sclerosis (MS) is a chronic autoimmune, inflammatory, demyelinating and/or neurodegenerative disease of the central nervous system. Plaques seen in patients with MS can lead to various symptoms (1). Sexual dysfunction, one of these symptoms, is common in MS patients and negatively affects their quality of life. Sexual dysfunction in MS can be classified as primary, secondary and tertiary. Primary sexual dysfunction is due to the effects of demyelinating lesions on the spinal cord or brain. Secondary dysfunction is due to the physical disorders associated with MS and the side effects of drugs. They indirectly affect the sexual response. Fatigue, loss of attention and concentration, difficulties with movement, coordination disorders, muscle stiffness, bladder and bowel dysfunction, muscle weakness, lower extremity weakness, tremor, pain and drug side effects can be counted as examples of these side effects. Tertiary sexual disorder is the cultural, social and psychological effects of MS. Although sexual dysfunction is a common problem in MS, it is difficult to diagnose and treat because it is not mentioned or questioned. There is no reliable specific treatment for sexual dysfunction for women with MS, but a multidisciplinary approach involving physicians, nurses, sexual therapists, and psychologists is one of the most important components of care for MS patients. It is necessary to provide enough information to the patients about sexual dysfunctions and to enable them to learn the effect of MS on sexuality and current practices in a clear and easy way (3,4).
It is recommended that health professionals use models in order to comprehensively evaluate sexuality and focus on solving sexual problems (5,6). The use of models in the evaluation of sexuality guides health professionals in facilitating the history-taking process and determining sexual problems. The P-LISS-IT model, one of the recommended models for sexual counseling, provides four levels of approach to each problem of the individual: P (Permission): Allowing, Ll (Limited Information): Giving limited information, SS (Specific Suggestions): Giving specific suggestions, IT (Intensive Therapy) is expressed as Intensive Therapy (6). Although there are a limited number of studies showing that sexual counseling based on the PLISSIT model is effective in solving sexual problems in patients with MS, uncertainty about the long-term effects of sexual counseling continues (7-10). In this study, an alternative to the treatment of sexual problems of women with MS was investigated by comprehensively evaluating women with MS with sexual problems in a randomized controlled design in line with the PLISSIT model, examining the long-term effectiveness of sexual counseling by comparing it with the control group, and evaluating the results with concrete, valid and reliable tools. an opportunity to develop a solution approach will be provided. In addition, due to the limited number of studies, it is thought that it will make an important contribution to the literature.
In this study, the following hypotheses will be tested;
- Sexual functions of women with MS given sexual counseling based on the PLISSIT model are better than women in the control group.
- Sexual life quality of women with MS who received sexual counseling based on the PLISSIT model is better than women in the control group.
- Conditions
- Multiple Sclerosis, Female Sexual Dysfunction
- Being tested
- sexual counselling with PLISSIT model
- 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 counselling with PLISSIT modelOther
sexual counselling with PLISSIT model
| Study group | Role | What they receive |
|---|---|---|
| sexual counselling group | Experimental | Women with MS who are given sexual counseling along with the training booklet will form the sexual counseling group. Receives: Other: sexual counselling with PLISSIT model |
| control group | No intervention | Women with MS who are not given sexual counseling will form the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sexual function
Multiple Sclerosis Intimacy and Sexuality Questionnaire
Measured: 1 year
Secondary outcomes (1)
sexual quality of life
Sexual Quality of Life Questionnaire-Female
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Aug 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- It was planned in a randomized controlled type.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Tuncer, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004518
- Sponsor's protocol ID
- 2023/870
- Status last verified
- Aug 2023
- First submitted
- 16 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sexual Counseling With the PLISSIT Model on Sexual Function and Sexual Quality of Life in Women With Multiple Sclerosis: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06004518
- Acronym / sponsor ID
- 2023/870
- Conditions
- Multiple Sclerosis, Female Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 22 Aug 2023 (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.
Multiple Sclerosis (MS) is a chronic neuroinflammatory disease of the central nervous system that is common in young ages and women. Plaques formed in MS can develop at any point in the brain and spinal cord, causing various symptoms and adversely affecting the patient's quality of life. Although not counted among the affected neurological systems, one of the most important symptoms experienced by MS patients is sexual dysfunction. Sexual dysfunction in MS may occur due to symptoms of MS such as spasticity, fatigue, and bladder problems, due to the presence of lesions affecting the neural pathways. The most common method used in the treatment of sexual dysfunction in women with MS is sexual counseling. The PLISSIT model is one of the most frequently used models by health professionals in sexual counseling and evaluation. PLISSIT stands for Permission, limited Information, Specific Suggestion and Intensive Therapy.
In this randomized controlled study, the long-term effect of sexual counseling given to female MS patients with the PLISSIT model on sexual function and sexual quality of life will be evaluated. The study is planned to be carried out between July 2023 and December 2024 in the MS and Demyenizing Diseases Unit of Istanbul University Istanbul Medical Faculty Hospital, Department of Neurology. The sample size was calculated as 86, 43 in the sexual counseling group and 43 in the control group, in the G*Power (v3.1.9.7) program using the power analysis method. The data of the study will be collected with the "Descriptive Information Form", "Multiple Sclerosis Intimacy and Sexuality Questionnaire-15", "Sexual Quality of Life Questionnaire for Women", "Patient Health Questionnaire-4" and "Fatigue Severity Scale" developed by the researchers.
The data will be analyzed in SPPS 28 package program. Number, percentage, mean, standard deviation, median and minimum-maximum values will be given in descriptive statistics. The t-test for independent samples/Mann-Whitney U test will be used to compare the mean score of the dependent variables of the two groups. Paired groups t-test/Wilcoxon test will be used in the comparison of each group within the group.
As a result of the research, it is possible to develop an alternative solution approach to the treatment of sexual problems of women with MS by comprehensively evaluating women with MS with sexual problems in line with the PLISSIT model, suggesting solutions, examining the long-term effectiveness of sexual counseling and evaluating the results with concrete, valid and reliable tools. will be provided.
Detailed description
Multiple sclerosis (MS) is a chronic autoimmune, inflammatory, demyelinating and/or neurodegenerative disease of the central nervous system. Plaques seen in patients with MS can lead to various symptoms (1). Sexual dysfunction, one of these symptoms, is common in MS patients and negatively affects their quality of life. Sexual dysfunction in MS can be classified as primary, secondary and tertiary. Primary sexual dysfunction is due to the effects of demyelinating lesions on the spinal cord or brain. Secondary dysfunction is due to the physical disorders associated with MS and the side effects of drugs. They indirectly affect the sexual response. Fatigue, loss of attention and concentration, difficulties with movement, coordination disorders, muscle stiffness, bladder and bowel dysfunction, muscle weakness, lower extremity weakness, tremor, pain and drug side effects can be counted as examples of these side effects. Tertiary sexual disorder is the cultural, social and psychological effects of MS. Although sexual dysfunction is a common problem in MS, it is difficult to diagnose and treat because it is not mentioned or questioned. There is no reliable specific treatment for sexual dysfunction for women with MS, but a multidisciplinary approach involving physicians, nurses, sexual therapists, and psychologists is one of the most important components of care for MS patients. It is necessary to provide enough information to the patients about sexual dysfunctions and to enable them to learn the effect of MS on sexuality and current practices in a clear and easy way (3,4).
It is recommended that health professionals use models in order to comprehensively evaluate sexuality and focus on solving sexual problems (5,6). The use of models in the evaluation of sexuality guides health professionals in facilitating the history-taking process and determining sexual problems. The P-LISS-IT model, one of the recommended models for sexual counseling, provides four levels of approach to each problem of the individual: P (Permission): Allowing, Ll (Limited Information): Giving limited information, SS (Specific Suggestions): Giving specific suggestions, IT (Intensive Therapy) is expressed as Intensive Therapy (6). Although there are a limited number of studies showing that sexual counseling based on the PLISSIT model is effective in solving sexual problems in patients with MS, uncertainty about the long-term effects of sexual counseling continues (7-10). In this study, an alternative to the treatment of sexual problems of women with MS was investigated by comprehensively evaluating women with MS with sexual problems in a randomized controlled design in line with the PLISSIT model, examining the long-term effectiveness of sexual counseling by comparing it with the control group, and evaluating the results with concrete, valid and reliable tools. an opportunity to develop a solution approach will be provided. In addition, due to the limited number of studies, it is thought that it will make an important contribution to the literature.
In this study, the following hypotheses will be tested;
- Sexual functions of women with MS given sexual counseling based on the PLISSIT model are better than women in the control group.
- Sexual life quality of women with MS who received sexual counseling based on the PLISSIT model is better than women in the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It was planned in a randomized controlled type.
| Arm | Type | Receives |
|---|---|---|
| sexual counselling group | Experimental | Other: sexual counselling with PLISSIT modelWomen with MS who are given sexual counseling along with the training booklet will form the sexual counseling group. |
| control group | No intervention | –Women with MS who are not given sexual counseling will form the control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- • Women between the ages of 18-45,
Key exclusion criteria (1 listed)
- Women with urinary and stool incontinence problems, menopausal or premenopausal symptoms, a major psychiatric problem and using antidepressant medication, an inflammatory disease such as ankylosing spondylitis or rheumatoid arthritis, substance abuse and those who do not volunteer to participate in the study will not be included.
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 counselling with PLISSIT modelsexual counselling with PLISSIT model | Other | sexual counselling group |
Primary outcome
sexual function
Time frame: 1 year
Multiple Sclerosis Intimacy and Sexuality Questionnaire
1 secondary outcome
sexual quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: Undecided. 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.
The record lists no contact. Use the official record to reach the sponsor.
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 counselling with PLISSIT model in people with Multiple Sclerosis and Female Sexual Dysfunction, run by Istanbul 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 11 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Aug 2023. 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?
Results are not available in the source record.
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?
sexual function (time frame: 1 year). 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 22 Aug 2023.