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The Effect of Structured Education on Sexual Function and Sexual Quality of Life

Primary Purpose

Arthropathy of Hip, Sexuality, Orthopedic Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Education group
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arthropathy of Hip

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: >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. Exclusion Criteria: having a history of spinal surgery, having cancer, having a psychological or gynecological/urological disease, Exclusion criteria from the study; 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.

Sites / Locations

  • Hatice ÖNER CENGİZRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Education group

Control group

Arm Description

Structured 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.

The clinic's routine discharge training will be applied to the participants in the control group.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Fear of sexual activity-first evaluation
Fear of sexual activity will be evaluated 4 times in the perioperative period.The patient's fear of sexual activity will be evaluated with the VAS. The scale has "no fear" at the left end (0) and "most intense fear possible" at the right end (10). A high score from the scale indicates a high level of fear, while a score of 0 indicates that there is no fear.
Fear of sexual activity-second evaluation
Fear of sexual activity will be evaluated 4 times in the perioperative period.The patient's fear of sexual activity will be evaluated with the VAS. The scale has "no fear" at the left end (0) and "most intense fear possible" at the right end (10). A high score from the scale indicates a high level of fear, while a score of 0 indicates that there is no fear.
Fear of sexual activity-third evaluation
Fear of sexual activity will be evaluated 4 times in the perioperative period.The patient's fear of sexual activity will be evaluated with the VAS. The scale has "no fear" at the left end (0) and "most intense fear possible" at the right end (10). A high score from the scale indicates a high level of fear, while a score of 0 indicates that there is no fear.
Fear of sexual activity-fourth evaluation
Fear of sexual activity will be evaluated 4 times in the perioperative period.The patient's fear of sexual activity will be evaluated with the VAS. The scale has "no fear" at the left end (0) and "most intense fear possible" at the right end (10). A high score from the scale indicates a high level of fear, while a score of 0 indicates that there is no fear.
satisfaction with sexual activity-first evaluation
satisfaction with sexual activity will be evaluated 4 times in the perioperative period.The patient's satisfaction with sexual activity will be evaluated with the VAS. At the left end of the scale, "I am not satisfied at all" is written, and at the right end (10) "Highest possible satisfaction" is written. A high score from the scale indicates a high level of satisfaction, while a score of 0 indicates dissatisfaction.
satisfaction with sexual activity-second evaluation
satisfaction with sexual activity will be evaluated 4 times in the perioperative period.The patient's satisfaction with sexual activity will be evaluated with the VAS. At the left end of the scale, "I am not satisfied at all" is written, and at the right end (10) "Highest possible satisfaction" is written. A high score from the scale indicates a high level of satisfaction, while a score of 0 indicates dissatisfaction.
satisfaction with sexual activity-third evaluation
satisfaction with sexual activity will be evaluated 4 times in the perioperative period.The patient's satisfaction with sexual activity will be evaluated with the VAS. At the left end of the scale, "I am not satisfied at all" is written, and at the right end (10) "Highest possible satisfaction" is written. A high score from the scale indicates a high level of satisfaction, while a score of 0 indicates dissatisfaction.
satisfaction with sexual activity-fourth evaluation
satisfaction with sexual activity will be evaluated 4 times in the perioperative period.The patient's satisfaction with sexual activity will be evaluated with the VAS. At the left end of the scale, "I am not satisfied at all" is written, and at the right end (10) "Highest possible satisfaction" is written. A high score from the scale indicates a high level of satisfaction, while a score of 0 indicates dissatisfaction.

Full Information

First Posted
March 17, 2023
Last Updated
October 9, 2023
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT05808959
Brief Title
The Effect of Structured Education on Sexual Function and Sexual Quality of Life
Official Title
The Effect of Structured Education on Sexual Function and Sexual Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Total Hip Arthroplasty (TKA) is a successful and major treatment modality that provides pain reduction/relief, functional recovery and increase in quality of life in patients with knee osteoarthritis and osteonecrosis (Turhan and Büyük 2022, Yamagami et al. 2021, Lei et al. 2019). The indication for TKA is increasing, especially in young patients with high functional expectations and who are sexually active (Kurtz et al. 2014). The World Health Organization (WHO) sexual health is "…a state of physical, emotional, mental and social well-being in relation to sexuality; it is not just the absence of disease, dysfunction, or disability." It has been defined as an important area of quality of life (WHO 2006). 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 patients (Neonakis et al 2020). Interruption or forcing of sexual life for a long time in the osteoarthritis process can also increase the expectations of patients from TKA intervention. However, after TKA, patients may limit themselves sexually, especially due to the fear of dislocation (Pritchett 2017, Yoon et al. 2013). It is clear that pre- and post-TKA sexual counseling is important when preparing for a balanced resumption of sexual activity in female patients after THA (Neonakis et al 2020). However, in clinical practice, patients may hesitate to talk about sexual life, and orthopedists and nurses often ignore this (Charbonnier et al. 2014, Peter et al. 2011). In one study, most of the patients could not get information about sexual activity after TKA and did not consult a doctor because of the specificity of the subject (Yoon et al. 2013), whereas in another study, only 17% of the patients received information about the onset of sexual activity and risky positions after surgery (Laffosse et al. 2008) were determined. However, some changes should be made in the sexual activities of patients after TKA intervention. Permissible sexual position after TKA differs according to gender, the approach used and the time after surgery. For this reason, it is very important for patients to receive an individualized education on sexual life for their postoperative sexual health (Neonakis et al. 2020). However, no study has been found in the literature evaluating the effectiveness of any training given to patients undergoing TKA in the pre- or postoperative period. In the light of this information, the aim of the study is to determine the effect of structured education on sexuality on sexual function and quality of sexual life in female patients undergoing TKA. Method This single-center, randomized controlled trial Participants and Sample The population of the study will be female patients who underwent TKA in the clinic where the study will be conducted. G*Power (version 3.1.9.4) analysis was performed to determine sample size. it was planned to include 34 patients in total, 17 patients in each group. Education Group; Their spouses will also participate in the structured sexual health education to be given to the women included in the training group and they will give their consent. Within the scope of the training, the definition of total hip replacement, the importance of sexual health, the definition of sexual intimacy, the ways of sexual intimacy, the general precautions that the patient should pay attention to in sexual life after TKA, the positions that should not be used during sexual intercourse in the early and late postoperative period, in the early postoperative period and In the late period, positions that can be used during sexual intercourse will be trained. It is thought that the training will take approximately 45-60 minutes in total. Control Group; The participants in the control group will be given routine care of the clinic. Data Collection The data of the patient will be collected by the researchers face-to-face and through telephone interviews, using the Patient Sociodemographic and Medical Data Form, Female Sexual Function Questionnaire Index, Sexual Life Quality Scale-Female (CYQQ-F), Visual Analogue Scale (VAS). Evaluation of Research Data SPSS 22.0 (IBM Corp., Armonk, NY) package program will be used in the evaluation of the data obtained from the research. Descriptive statistics will be presented as numbers, percentages, mean±standard deviation (SD), and median (min-max) values. Fisher's Exact Test or Pearson chi-square test will be used in the analysis of relationships between categorical variables. In the normality test, Shapiro Wilks test will be used when the number of samples in the group is less than 50, and Kolmogorov-Smirnov test will be used when it is large. In the analysis of the changes in the scores over time, the Kruskal Wallis test will be used if the measurements do not comply with the normal distribution, and the ANOVA test will be used if the measurements comply with the normal distribution. In the analysis of the difference between the scores of the two groups, the Mann-Whitney U test will be used if it does not fit the normal distribution, and the Student's t test will be used if it does. The reliability coefficient of the scales used in the study will be determined by calculating the Cronbach alpha coefficient. P values less than 0.05 will be considered statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Hip, Sexuality, Orthopedic Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education group
Arm Type
Experimental
Arm Description
Structured 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The clinic's routine discharge training will be applied to the participants in the control group.
Intervention Type
Behavioral
Intervention Name(s)
Education group
Intervention Description
After the discharge training given at the clinic in the postoperative period, the participants will be given structured training on sexual health.
Primary Outcome Measure Information:
Title
Sexual function-first evaluation
Description
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.
Time Frame
before surgery
Title
Sexual function-second evaluation
Description
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.
Time Frame
1 month after surgery
Title
Sexual function-third evaluation
Description
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.
Time Frame
3 month after surgery
Title
Sexual function-fourth evaluation
Description
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.
Time Frame
6 month after surgery
Title
Sexual Quality of Life--first evaluation
Description
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.
Time Frame
before surgery
Title
Sexual Quality of Life--second evaluation
Description
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.
Time Frame
1 month after surgery
Title
Sexual Quality of Life--third evaluation
Description
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.
Time Frame
3 month after surgery
Title
Sexual Quality of Life--fourth evaluation
Description
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.
Time Frame
6 month after surgery
Secondary Outcome Measure Information:
Title
Fear of sexual activity-first evaluation
Description
Fear of sexual activity will be evaluated 4 times in the perioperative period.The patient's fear of sexual activity will be evaluated with the VAS. The scale has "no fear" at the left end (0) and "most intense fear possible" at the right end (10). A high score from the scale indicates a high level of fear, while a score of 0 indicates that there is no fear.
Time Frame
before surgery
Title
Fear of sexual activity-second evaluation
Description
Fear of sexual activity will be evaluated 4 times in the perioperative period.The patient's fear of sexual activity will be evaluated with the VAS. The scale has "no fear" at the left end (0) and "most intense fear possible" at the right end (10). A high score from the scale indicates a high level of fear, while a score of 0 indicates that there is no fear.
Time Frame
1 month after surgery
Title
Fear of sexual activity-third evaluation
Description
Fear of sexual activity will be evaluated 4 times in the perioperative period.The patient's fear of sexual activity will be evaluated with the VAS. The scale has "no fear" at the left end (0) and "most intense fear possible" at the right end (10). A high score from the scale indicates a high level of fear, while a score of 0 indicates that there is no fear.
Time Frame
3 month after surgery
Title
Fear of sexual activity-fourth evaluation
Description
Fear of sexual activity will be evaluated 4 times in the perioperative period.The patient's fear of sexual activity will be evaluated with the VAS. The scale has "no fear" at the left end (0) and "most intense fear possible" at the right end (10). A high score from the scale indicates a high level of fear, while a score of 0 indicates that there is no fear.
Time Frame
6 month after surgery
Title
satisfaction with sexual activity-first evaluation
Description
satisfaction with sexual activity will be evaluated 4 times in the perioperative period.The patient's satisfaction with sexual activity will be evaluated with the VAS. At the left end of the scale, "I am not satisfied at all" is written, and at the right end (10) "Highest possible satisfaction" is written. A high score from the scale indicates a high level of satisfaction, while a score of 0 indicates dissatisfaction.
Time Frame
before surgery
Title
satisfaction with sexual activity-second evaluation
Description
satisfaction with sexual activity will be evaluated 4 times in the perioperative period.The patient's satisfaction with sexual activity will be evaluated with the VAS. At the left end of the scale, "I am not satisfied at all" is written, and at the right end (10) "Highest possible satisfaction" is written. A high score from the scale indicates a high level of satisfaction, while a score of 0 indicates dissatisfaction.
Time Frame
1 month after surgery
Title
satisfaction with sexual activity-third evaluation
Description
satisfaction with sexual activity will be evaluated 4 times in the perioperative period.The patient's satisfaction with sexual activity will be evaluated with the VAS. At the left end of the scale, "I am not satisfied at all" is written, and at the right end (10) "Highest possible satisfaction" is written. A high score from the scale indicates a high level of satisfaction, while a score of 0 indicates dissatisfaction.
Time Frame
3 month after surgery
Title
satisfaction with sexual activity-fourth evaluation
Description
satisfaction with sexual activity will be evaluated 4 times in the perioperative period.The patient's satisfaction with sexual activity will be evaluated with the VAS. At the left end of the scale, "I am not satisfied at all" is written, and at the right end (10) "Highest possible satisfaction" is written. A high score from the scale indicates a high level of satisfaction, while a score of 0 indicates dissatisfaction.
Time Frame
6 month after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >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. Exclusion Criteria: having a history of spinal surgery, having cancer, having a psychological or gynecological/urological disease, Exclusion criteria from the study; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hatice ÖNER CENGİZ, Ph.D.
Phone
+905542672908
Email
htcnr8878@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Neslihan YILMAZ SEZER, M.D.
Phone
+905062006460
Email
ylmzneslihan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice ÖNER CENGİZ
Organizational Affiliation
Ankara University
Official's Role
Study Director
Facility Information:
Facility Name
Hatice ÖNER CENGİZ
City
Altındağ
State/Province
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hatice ÖNER CENGİZ, PhD.
Phone
+905542672908
Email
htcnr8878@gmail.com

12. IPD Sharing Statement

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The Effect of Structured Education on Sexual Function and Sexual Quality of Life

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