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

NCT06004518 | Unknown

• 1 other identifier: 2023/870
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Multiple Sclerosis; Female Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• sexual function

  Multiple Sclerosis Intimacy and Sexuality Questionnaire

  1 year

Secondary Outcomes (1)

• sexual quality of life

  1 year

Study Arms (2)

sexual counselling group

EXPERIMENTAL

Women with MS who are given sexual counseling along with the training booklet will form the sexual counseling group.

Other: sexual counselling with PLISSIT model

control group

NO INTERVENTION

Women with MS who are not given sexual counseling will form the control group.

Interventions

sexual counselling with PLISSIT model OTHER

sexual counselling with PLISSIT model

sexual counselling group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Merve TUNCER

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Model Details: It was planned in a randomized controlled type.

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 22, 2023
• Study Start: August 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

TU (1)