Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06004518
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-22
First Post:
2023-08-16
Brief 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
Sponsor:
Istanbul University
Organization:
Istanbul University
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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 GPower v3197 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 samplesMann-Whitney U test will be used to compare the mean score of the dependent variables of the two groups Paired groups t-testWilcoxon 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
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 GPower v3197 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 samplesMann-Whitney U test will be used to compare the mean score of the dependent variables of the two groups Paired groups t-testWilcoxon 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 andor 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 34
It is recommended that health professionals use models in order to comprehensively evaluate sexuality and focus on solving sexual problems 56 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
It is recommended that health professionals use models in order to comprehensively evaluate sexuality and focus on solving sexual problems 56 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None