The Effect of Structured Education on Sexual Function and Sexual Quality of Life
1 other identifier
interventional
34
1 country
1
Brief Summary
An active sex life has an important place for the quality of life and is closely related to the increase in the general health level. In this context, a healthy sexual life after TKA surgery can contribute to the general quality of life of the patients. In the pre-TKA period, the sexual activity of female patients was found to be impaired more than men, the relationship between spouses was significantly affected negatively, and in the post-TKA period, general sexual recovery was significantly delayed in female patients compared to men. From this perspective, it is clear that pre- and post-TKA sexual counseling is important when preparing a balanced resumption of sexual activity in female patients after TKA. However, in clinical practice, patients may hesitate to talk about sexual life, and orthopedists and nurses often ignore this.
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 Apr 2023
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
March 17, 2023
CompletedFirst Posted
Study publicly available on registry
April 12, 2023
CompletedStudy Start
First participant enrolled
April 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2024
CompletedApril 30, 2024
April 1, 2024
11 months
March 17, 2023
April 29, 2024
Conditions
Outcome Measures
Primary Outcomes (8)
Sexual function-first evaluation
Sexual function will be evaluated 4 times in the perioperative period.Data will be collected with the Female Sexual Function Questionnaire Index. The highest score that can be obtained from the scale is 45, and as the total score decreases, it is considered as a decrease in sexual function.
before surgery
Sexual function-second evaluation
Sexual function will be evaluated 4 times in the postoperative period.Data will be collected with the Female Sexual Function Questionnaire Index. The highest score that can be obtained from the scale is 45, and as the total score decreases, it is considered as a decrease in sexual function.
1 month after surgery
Sexual function-third evaluation
Sexual function will be evaluated 4 times in the postoperative period.Data will be collected with the Female Sexual Function Questionnaire Index. The highest score that can be obtained from the scale is 45, and as the total score decreases, it is considered as a decrease in sexual function.
3 month after surgery
Sexual function-fourth evaluation
Sexual function will be evaluated 4 times in the postoperative period.Data will be collected with the Female Sexual Function Questionnaire Index. The highest score that can be obtained from the scale is 45, and as the total score decreases, it is considered as a decrease in sexual function.
6 month after surgery
Sexual Quality of Life--first evaluation
Sexual quality of life will be evaluated 4 times in the perioperative period.Data will be collected with the Sexual Life Quality Scale-Female (CYKÖ-K). The score that can be obtained from the scale is between 18-108. A high score from the scale indicates that the quality of sexual life is good.
before surgery
Sexual Quality of Life--second evaluation
Sexual quality of life will be evaluated 4 times in the perioperative period.Data will be collected with the Sexual Life Quality Scale-Female (CYKÖ-K). The score that can be obtained from the scale is between 18-108. A high score from the scale indicates that the quality of sexual life is good.
1 month after surgery
Sexual Quality of Life--third evaluation
Sexual quality of life will be evaluated 4 times in the perioperative period.Data will be collected with the Sexual Life Quality Scale-Female (CYKÖ-K). The score that can be obtained from the scale is between 18-108. A high score from the scale indicates that the quality of sexual life is good.
3 month after surgery
Sexual Quality of Life--fourth evaluation
Sexual quality of life will be evaluated 4 times in the perioperative period.Data will be collected with the Sexual Life Quality Scale-Female (CYKÖ-K). The score that can be obtained from the scale is between 18-108. A high score from the scale indicates that the quality of sexual life is good.
6 month after surgery
Secondary Outcomes (8)
Fear of sexual activity-first evaluation
before surgery
Fear of sexual activity-second evaluation
1 month after surgery
Fear of sexual activity-third evaluation
3 month after surgery
Fear of sexual activity-fourth evaluation
6 month after surgery
satisfaction with sexual activity-first evaluation
before surgery
- +3 more secondary outcomes
Study Arms (2)
Education group
EXPERIMENTALStructured training on sexual health will be given to patients in this group. After the discharge training given at the clinic in the postoperative period, the participants will be given structured training on sexual health. It is anticipated that the training will take approximately 30 minutes. Immediately after the training, feedback will be received from the patient through a question-answer activity, and areas that are not understood will be repeated. It is thought that the training will take approximately 45-60 minutes in total.
Control group
NO INTERVENTIONThe clinic's routine discharge training will be applied to the participants in the control group.
Interventions
After the discharge training given at the clinic in the postoperative period, the participants will be given structured training on sexual health.
Eligibility Criteria
You may qualify if:
- \>18-\<65 years old,
- have no barriers to communicating,
- able to understand and speak Turkish,
- sexually active before and after TKA,
- with her husband,
- patients without sexual dysfunction will be included.
You may not qualify if:
- having a history of spinal surgery,
- having cancer,
- developing surgical site infection after TKA,
- do not complete the study,
- developing any complications during the working process,
- patients who lost their lives during the study will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hatice ÖNER CENGİZ
Altındağ, Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hatice ÖNER CENGİZ
Ankara University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist. Prof.
Study Record Dates
First Submitted
March 17, 2023
First Posted
April 12, 2023
Study Start
April 27, 2023
Primary Completion
April 5, 2024
Study Completion
April 5, 2024
Last Updated
April 30, 2024
Record last verified: 2024-04