Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06004518 |
| Other study ID # |
2023/870 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2023 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
August 2023 |
| Source |
Istanbul University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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;
1. Sexual functions of women with MS given sexual counseling based on the PLISSIT model are
better than women in the control group.
2. Sexual life quality of women with MS who received sexual counseling based on the PLISSIT
model is better than women in the control group.
