- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05661630
THE EFFECT OF SEX EDUCATION AND COUNSELING GIVEN TO WOMEN WITH STOMIA WITH THE EX-PLISSIT MODEL ON SEXUAL LIFE
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Altındağ
-
Ankara, Altındağ, Turkey (Türkiye), 06230
- Ankara University Ibni Sina Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18/173
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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