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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05661630
Other study ID # 18/173
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2, 2023
Est. completion date December 29, 2023

Study information

Verified date December 2022
Source Ankara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, it was aimed to determine the effect of sexual education and counseling given to women with stoma with the Ex-PLISSIT model on their sexual life quality and sexual life satisfaction. H1: Female patients with permanent stoma who were given sexual education and 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 education and counseling with the EX-PLISSIT model had higher mean scores of sexual life satisfaction.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 32
Est. completion date December 29, 2023
Est. primary completion date December 29, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
EDUCATION AND COUNSELING WITH EX-PLISSIT MODEL
In addition to the routine procedure, the women in the experimental group of the research will be given sexual education and 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
NESLIHAN YILMAZ SEZER

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Change in satisfaction with sexual life 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
Primary 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
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