CClinicalTrials.gg
CompletedNCT05661630Updated May 5, 2026

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

An interventional study of COUNSELING WITH EX-PLISSIT MODEL in Stoma Colostomy and Stoma Ileostomy, sponsored by NESLİHAN YILMAZ SEZER. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by NESLİHAN YILMAZ SEZER · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Stoma Colostomy
  • Stoma Ileostomy
03

In context

Lead sponsor

NESLİHAN YILMAZ SEZER is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    EX-PLISSIT

    Other: COUNSELING WITH EX-PLISSIT MODEL

  • No intervention
    CONTROL

Interventions

  • OtherCOUNSELING WITH EX-PLISSIT MODEL

    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.

06

What researchers measure

Primary outcomes

  1. Change in Sexual Life Quality

    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.

    Time frame: at the beginning of the study, 1 month later and 3 months later

  2. Change in sexual satisfaction

    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.

    Time frame: at the beginning of the study, 1 month later and 3 months later

  3. Change in satisfaction with marital relationship

    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.

    Time frame: at the beginning of the study, 1 month later and 3 months later

07

Study locations

1 site
  • Ankara University İbni Sina Hospital
    Ankara, Altındağ 06230, Turkey (Türkiye)
08

References and documents

Publications

  • Yilmaz Sezer N, Aker MN, Oner Cengiz H, Ersoz S, Aydin D. The effect of sexual counseling based on the Ex-PLISSIT model on sexual quality of life and sexual satisfaction in women with stoma: a randomized controlled trial. J Sex Med. 2025 Sep 4;22(9):1673-1680. doi: 10.1093/jsxmed/qdaf179. PubMed 40753509 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05661630
Lead sponsor
NESLİHAN YILMAZ SEZER
Responsible party
NESLİHAN YILMAZ SEZER (Faculty of Nursing, Ankara University) — Sponsor-investigator
First posted
Dec 22, 2022
Start date
Sep 4, 2023
Primary completion
Apr 25, 2024
Completion
Apr 25, 2024
Last update
May 5, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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