Stoma ColostomyNCT05661630
THE EFFECT OF SEX EDUCATION AND COUNSELING GIVEN TO WOMEN WITH STOMIA WITH THE EX-PLISSIT MODEL ON SEXUAL LIFE
A study testing COUNSELING WITH EX-PLISSIT MODEL in people with Stoma Colostomy and Stoma Ileostomy, run by NESLİHAN YILMAZ SEZER at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stoma Colostomy, Stoma Ileostomy
- What is being tested?
- COUNSELING WITH EX-PLISSIT MODEL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Sep 2023to 25 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University İbni Sina Hospital
Ankara, Altındağ, 06230
About this study
Official title: 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.
- Conditions
- Stoma Colostomy, Stoma Ileostomy
- Being tested
- COUNSELING WITH EX-PLISSIT MODEL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COUNSELING WITH EX-PLISSIT MODELOther
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.
| Study group | Role | What they receive |
|---|---|---|
| EX-PLISSIT | Experimental | Not described Receives: Other: COUNSELING WITH EX-PLISSIT MODEL |
| CONTROL | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the beginning of the study, 1 month later and 3 months later
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.
Measured: at the beginning of the study, 1 month later and 3 months later
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.
Measured: at the beginning of the study, 1 month later and 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start4 Sep 2023
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stoma ColostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- NESLİHAN YILMAZ SEZER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, NESLİHAN YILMAZ SEZER, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661630
- Sponsor's protocol ID
- 18/173
- Status last verified
- Apr 2026
- First submitted
- 14 Dec 2022
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05661630
- Acronym / sponsor ID
- 18/173
- Conditions
- Stoma Colostomy, Stoma Ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- NESLİHAN YILMAZ SEZERUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EX-PLISSIT | Experimental | Other: COUNSELING WITH EX-PLISSIT MODEL |
| CONTROL | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COUNSELING WITH EX-PLISSIT MODELIn 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. | Other | EX-PLISSIT |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 40753509Yilmaz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COUNSELING WITH EX-PLISSIT MODEL in people with Stoma Colostomy and Stoma Ileostomy, run by NESLİHAN YILMAZ SEZER at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sexual Life Quality (time frame: at the beginning of the study, 1 month later and 3 months later). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05661630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.