Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05808959
Study type Interventional
Source Ankara University
Contact
Status Completed
Phase N/A
Start date April 27, 2023
Completion date April 5, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05864833 - METabolism After Orthopedic Surgery
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Recruiting NCT05461326 - Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT N/A
Completed NCT06080685 - Efficacy of Character Strengths Intervention in Enhancing Character Strengths and Self-esteem Among Adolescents N/A
Not yet recruiting NCT06326827 - In'Oss™ (MBCP® Putty) Ortho
Not yet recruiting NCT06002009 - SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function
Completed NCT04730115 - Evaluation of Architectural Changes in Mandibular Bone Pattern After Functional Treatment by Fractal Dimension Analysis
Withdrawn NCT03436667 - Perioperative Factors Impacting Surgical Risk and Outcomes in Children
Completed NCT03299920 - Opioid Consumption After Knee Arthroscopy N/A
Active, not recruiting NCT05075525 - EFFECT OF HIGH INTENSITY LASER IN PATELLOFEMORAL PAIN SYNDROME N/A
Completed NCT06158165 - Evaluating The Cardiovascular Effects of Tourniquet Application
Recruiting NCT04891549 - Tension Band Versus Locking Plate Fixation for the Treatment of Patella Fractures N/A
Recruiting NCT04676841 - Wound Contamination During Orthopaedic Surgery
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Completed NCT04514601 - A Quality Improvement Project to Assess and Refine the Handover Process at Morning Trauma Meetings
Not yet recruiting NCT04546594 - Epidemiological Data on Pain
Completed NCT05396924 - Rectal Temperature Measurement in Detecting Hypothermia During Hip Arthroscopy N/A
Active, not recruiting NCT06438835 - Development & Evaluation of Pneumatic Artificial Muscle(PAM) for Patients With Ankle Foot Orthosis(AFO) N/A
Active, not recruiting NCT05795127 - Risk for Reoperation After First MTP Joint Arthrodesis
Completed NCT04481711 - Total Knee Arthroplasty and Clinical Findings N/A