NCT06199219

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

December 27, 2023

Last Update Submit

January 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Secondary Outcomes (1)

  • New Sexual Satisfaction Scale (NSSS) Score

    8 weeks

Study Arms (2)

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

Other: Sexual counseling, based on the extended (EX-PLISSIT)

Control Group

NO INTERVENTION

No intervention pretest posttest

Interventions

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).

Intervention Group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vesile KOÇAK

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Sex Counseling

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SexologyBehavioral SciencesBehavioral Disciplines and ActivitiesCounselingMental Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Vesile Kocak

    Necmettin Erbakan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 27, 2023

First Posted

January 10, 2024

Study Start

May 10, 2023

Primary Completion

August 30, 2023

Study Completion

September 30, 2023

Last Updated

January 10, 2024

Record last verified: 2024-01

Locations