AzTrials
AzTrials

Arthropathy of HipNCT05808959

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

A study testing Education group in people with Arthropathy of Hip and Sexuality, run by Ankara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Arthropathy of Hip, Sexuality, Orthopedic Disorder
What is being tested?
Education group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
27 Apr 2023to 5 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hatice ÖNER CENGİZ

    Altındağ, Ankara

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
Education group
Medical subject headings
Sexuality, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education groupBehavioural

    After the discharge training given at the clinic in the postoperative period, the participants will be given structured training on sexual health.

Study groups in NCT05808959
Study groupRoleWhat they receive
Education groupExperimentalStructured 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.
Receives: Behavioral: Education group
Control groupNo interventionThe clinic's routine discharge training will be applied to the participants in the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: before surgery

  2. 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.

    Measured: 1 month after surgery

  3. 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.

    Measured: 3 month after surgery

  4. 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.

    Measured: 6 month after surgery

  5. 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.

    Measured: before surgery

  6. 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.

    Measured: 1 month after surgery

  7. 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.

    Measured: 3 month after surgery

  8. 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.

    Measured: 6 month after surgery

Secondary outcomes (8)
  1. 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.

    Measured: before surgery

  2. 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.

    Measured: 1 month after surgery

  3. 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.

    Measured: 3 month after surgery

  4. 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.

    Measured: 6 month after surgery

  5. 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.

    Measured: before surgery

  6. 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.

    Measured: 1 month after surgery

  7. 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.

    Measured: 3 month after surgery

  8. 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.

    Measured: 6 month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2023
  2. Study start27 Apr 2023
  3. Primary completion5 Apr 2024
  4. Study completion5 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05808959
Sponsor's protocol ID
HONERCENGIZ
Status last verified
Apr 2024
First submitted
17 Mar 2023
Last updated
30 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Education group in people with Arthropathy of Hip and Sexuality, run by Ankara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sexual function-first evaluation (time frame: before surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in