Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05088551
Other study ID # 14574941- 199-27487
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date April 1, 2020

Study information

Verified date October 2021
Source Bozok University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The reasons such as the advanced age of most patients with Total Knee Arthroplasty (TKA), the presence of concomitant diseases, and bilateral prostheses cause a decrease in the quality of life by negatively affecting the healing processes of the patients. Patients who try to adapt to the problems experienced during postoperative recovery need the information to develop coping behaviors. Nurses play a crucial role in ensuring adequate and effective access of information to the patient during this challenging process, which significantly affects mobility and, consequently, life activities. Effective educational interventions to be implemented by nurses enable patients to make decisions about health problems and act to improve their quality of life. However, for patient education to be efficient, the information given must be easy to read, understandable, and suitable for various learning styles to cope with problems more effectively. Still, individuals with low health literacy have problems benefiting from all services provided, exceptionally patient education, at the desired level.


Description:

Patients with TKA face many problems in the early postoperative period and home processes after discharge. In this process, the instruction that will be given by nurses as a part of the care is critical. Patient education will contribute to less stress for patients, effective participation in their care, and more minor problems in the recovery process at home after discharge and increase positive patient outcomes. However, for the teaching to be effective, nurses must first determine the health literacy levels of individuals. When initiatives are planned following the level of health literacy, it is thought that individuals' adaptation to the duration of their health will increase, the process will progress effectively, the recovery will be positively affected, and the quality of life will increase. Accordingly, this study was conducted to examine the effect of the curriculum prepared according to patients' health literacy levels with TKA on the healing process and quality of life. Research hypotheses: H1a- Patient education, which is planned according to health literacy levels, positively affects patients' quality of life. H1b- Patient education, which is planned according to health literacy levels, reduces patients' problems on the 15th day after surgery. H1c- Patient education, which is planned according to health literacy levels, reduces patients' problems in the 6th week after surgery. H1d- Patient education, which is planned according to health literacy levels, affects the postoperative improvement in functional status in patients. Study Design: A control group intervention research. Method: 102 patients, 51 experimental groups, and 51 control groups participated in the study. The sample was chosen randomly from the universe by the researcher. From the patients hospitalized in the clinic and matching the research criteria, the control group was determined by random method according to the order of the patients, and their data were collected. Then, the intervention group data were obtained, paying attention to the similarity of the groups in terms of education, age, and gender. In the study, the education plan prepared in line with the control group data was applied to the intervention group, and its effects on the healing processes were observed. Data were collected with Patient Introduction, Patient Learning Requirements, Functional Evaluation, Turkey Health Literacy, Discharge Data Collection, Post-Discharge 15th and Sixth Week Recovery Process Data Collection, Quality of Life Forms.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date April 1, 2020
Est. primary completion date September 28, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients over 18 years - Patients who had undergone total knee arthroplasty surgery for the first time - Patients who did not have a history of psychiatric problems - Patients who were literate - Patients who agreed to participate for the study Exclusion Criteria: - Patients not over 18 years - Patients who hadn't undergone total knee arthroplasty surgery for the first time - Patients who had a history of psychiatric problems - Patients who weren't literate - Patients who didn' t agree to participate for the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Patient Education
The education was divided into three parts. The information in the first part of the booklet (general information, preoperative preparation, and operation day) is given in the preoperative period. In the postoperative period, the patients were visited and the information in the second part (postoperative hospital stay, first, second, and third-day goals after surgery) was given. Before the patients were discharged, the information in the third section (things to be considered in the recovery process at home) was presented. According to the physical conditions of the clinic, patient education was carried out in an area suitable for teaching as much as possible.

Locations

Country Name City State
Turkey Diskapi Yildirim Beyazit Training and Research Hospital Ankara Altindag

Sponsors (2)

Lead Sponsor Collaborator
Bozok University Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Quality of Life Scale Change (SF-36) The Quality of Life Scale (SF-36), one of the most used scales to measure quality of life; It is a self-assessment scale that can be filled in a short time and is highly sensitive.While applying the scale, individuals are asked to answer considering the last 4 weeks. The scale consists of 36 questions and 8 sub-parameters (body pain, limitation due to physical problems, limitation due to mental problems, mental well-being, fatigue, general health perception, social function and physical function). In scoring, each parameter is evaluated between 0 and 100 points. A score of 0 indicates poor health, and a score of 100 indicates good health. The higher the score, the higher the quality of life. 1st day of admission to the clinic change the quality of life score at before intervention, change from baseline the quality of life score at 3 days, change from baseline the quality of life score at 6 weeks
Secondary The Function Evaluation Form Change The Functional Evaluation Form was developed to determine the functional status of patients who had TKA surgery and hip replacement surgery. The form consists of 8 sections and each section is scored within itself. The highest possible score is 100. The increase in score indicates the improvement in the functional status. 1st day of admission to the clinic change the function evaluation score at before intervention, change from baseline the function evaluation score at 3 days, change from baseline the function evaluation score at 6 weeks
See also
  Status Clinical Trial Phase
Completed NCT03542981 - Interferential Current Therapy After Total Knee Arthroplasty N/A
Recruiting NCT04458480 - Effect of Fast Inpatient Rehabilitation After TKA
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Recruiting NCT06061367 - Muscles Strength and Gait Parameteres After TKA
Recruiting NCT05391828 - Persona MC vs PS RCT With ROSA N/A
Active, not recruiting NCT04850300 - Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses Phase 3
Completed NCT05635916 - Trial of Liposomal Bupivacaine for TKA Phase 4
Enrolling by invitation NCT05130216 - Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
Completed NCT03206554 - Local Infiltration Analgesia in Total Knee Arthroplasty Phase 2
Withdrawn NCT02495805 - Ultrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty N/A
Withdrawn NCT01511211 - Duration of Leg Nerve Blocks With Dexamethasone Added to Local Anesthetic Phase 4
Completed NCT01616836 - Optimizing Pain and Rehabilitation After Knee Arthroplasty Phase 3
Not yet recruiting NCT00958945 - Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements N/A
Completed NCT00985920 - Topical Tranexamic Acid for Total Knee Arthroplasty Phase 4
Completed NCT00761956 - A Study to Compare the NexGen CR and CR-Flex Knee Implants N/A
Completed NCT03289247 - Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty N/A
Terminated NCT03316118 - US Guided GNB vs Saline Injection for TKA Phase 4
Recruiting NCT05962970 - Continuous Adductor Canal Block in Fast Track Total Knee Arthroplasty N/A
Completed NCT03317834 - Navio With Total Knee Arthroplasty
Enrolling by invitation NCT06188091 - Joint Movement to Increase Range of Motion in Knee Joint After Primary Total Knee Arthroplasty N/A