THE EFFECT OF SEX EDUCATION AND COUNSELING GIVEN TO WOMEN WITH STOMIA WITH THE EX-PLISSIT MODEL ON SEXUAL LIFE
1 other identifier
interventional
32
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2022
CompletedFirst Posted
Study publicly available on registry
December 22, 2022
CompletedStudy Start
First participant enrolled
September 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2024
CompletedMay 5, 2026
April 1, 2026
8 months
December 14, 2022
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
at the beginning of the study, 1 month later and 3 months later
Study Arms (2)
EX-PLISSIT
EXPERIMENTALCONTROL
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- Using antidepressants or using sedatives
- Having a diagnosed psychiatric problem,
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara University İbni Sina Hospital
Ankara, Altındağ, 06230, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Faculty of Nursing
Study Record Dates
First Submitted
December 14, 2022
First Posted
December 22, 2022
Study Start
September 4, 2023
Primary Completion
April 25, 2024
Study Completion
April 25, 2024
Last Updated
May 5, 2026
Record last verified: 2026-04