THE EFFECT OF SEX EDUCATION AND COUNSELING GIVEN TO WOMEN WITH STOMIA WITH THE EX-PLISSIT MODEL ON SEXUAL LIFE

April 29, 2026 updated by: NESLİHAN YILMAZ SEZER

THE EFFECT OF SEX EDUCATION AND COUNSELING GIVEN TO WOMEN WITH STOMIA WITH EX-PLISSIT MODEL ON SEXUAL QUALITY OF LIFE AND SEXUAL LIFE SATISFACTION

In this study, it was aimed to determine the effect of sexual counseling given to women with stoma with the Ex-PLISSIT model on their sexual life quality and sexual satisfaction.

H1: Female patients with permanent stoma who were given sexual counseling with the EX-PLISSIT model had a higher quality of life score measured by the Sexual Quality of Life scale.

H2: Female patients with permanent stoma who were given sexual counseling with the EX-PLISSIT model had higher mean scores of sexual satisfaction.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Altındağ
      • Ankara, Altındağ, Turkey (Türkiye), 06230
        • Ankara University Ibni Sina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for Research

  • Permanent stoma for at least 6 months
  • Not receiving active surgical treatment, chemotherapy and radiotherapy (at least 6 previous treatments have been completed)
  • Married
  • Agreeing to participate in the research and obtaining written permission,
  • Over 18 years Research Exclusion Criteria
  • Using antidepressants or using sedatives
  • Having a diagnosed psychiatric problem,
  • Women with diagnosed sexual dysfunction will not be included in the study. Exclusion Criteria from Research
  • Do not complete the study,
  • Surgical treatment, radiotherapy or chemotherapy started due to an urgent necessity during the working process, Patients who die during the study will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CONTROL
Experimental: EX-PLISSIT

In addition to the routine procedure, the women in the experimental group of the research will be given sexual counseling with the EX-PLISSIT model. The steps to be followed in accordance with this model are as follows; Session 1 Permission Limited Information The Specific Suggestions The IT-Intensive Therapy Session 2 At the beginning of the interview, the data forms will be reapplied, and then the homework given in the first session will be discussed. The information that the patient needs in line with his questions will be given within the steps of the Ex-PLISSIT model, within the steps of allowing, limited information, special recommendations and, if necessary, intensive therapy.

Session 3 At the beginning of the interview, the data forms will be applied for the last time and the patient's questions, if any, will be answered and the session will be ended.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sexual Life Quality
Time Frame: at the beginning of the study, 1 month later and 3 months later
The scale is easy to apply, 6-point Likert type, which individuals can answer on their own, and consists of 18 items. Each item is expected to be answered considering the sexual life in the last four weeks. Each item of the scale is scored between 1 and 6. The items of the scale are scored as "I totally agree"=1, "I strongly agree"=2, "I partially agree"=3, "I partially disagree"=4, "I strongly disagree"=5, "I strongly disagree"=6 and 1 Questions 5, 9, 13 and 18 are reverse coded. The range of points that can be obtained from the scale is between 18-108.
at the beginning of the study, 1 month later and 3 months later
Change in satisfaction with marital relationship
Time Frame: at the beginning of the study, 1 month later and 3 months later
VAS is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfied and a score of 0 pointed to no satisfied.
at the beginning of the study, 1 month later and 3 months later
Change in sexual satisfaction
Time Frame: at the beginning of the study, 1 month later and 3 months later
VAS is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfied and a score of 0 pointed to no satisfied.
at the beginning of the study, 1 month later and 3 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2023

Primary Completion (Actual)

April 25, 2024

Study Completion (Actual)

April 25, 2024

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 22, 2022

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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