Quality of Life Clinical Trial
Official title:
Video-Assisted Education for Patients With Knee Replacement: Knee Function and Quality of Life
| Verified date | June 2021 |
| Source | Mersin University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Total knee replacement (TKR) is the most effective treatment modality for the correction of knee deformities, increasing the knee functions (KF), relieving pain, and improving quality of life (QoL) of patients. According to the health statistics of the Organisation for Economic Co-operation and Development (OECD), TKR is most commonly used in Sweden (240/100,000), United States (226/100,000), and Austria (215/100,000), while this rate is estimated as 67/100,000 in Turkey (OECD, 2017). Although it has been increasingly applied in Turkey and worldwide, it is associated with postoperative pain, restricted range of motion (ROM), and reduced muscle strength, leading to prolonged recovery process and return to activities of daily living (ADLs) with impaired QoL . In addition, inadequate patient education on knee care and ADLs following TKR may result in repetitive and uncontrollable movements and complications such as severe pain and dislocation. Postoperative complications have been shown to be associated with rehospitalization and redo surgery.
| Status | Completed |
| Enrollment | 44 |
| Est. completion date | August 1, 2019 |
| Est. primary completion date | March 30, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 33 Years to 81 Years |
| Eligibility | Inclusion Criteria: Written and verbal consent was obtained to participate in the research, - 18 years and over, - Conscious, oriented and cooperative, - Able to speak and understand Turkish, - Not diagnosed with any psychiatric illness, - No known cancer disease, - Elective surgical intervention applied, - Total knee replacement applied for the first time, - Unilateral total knee replacement applied, - Patients with an Standardized Mini-Mental Test score of 23 and above were included. Exclusion Criteria: To research: - Those who do not agree to participate in the research, - Under 18 years old, - Unconscious, without orientation and cooperation, - Can't speak or understand Turkish, - Having previously been diagnosed with a psychiatric diagnosis, - Having a history of cancer, - Emergency surgical intervention applied, - Total knee replacement applied before, - Bilateral (bilateral) total knee replacement applied, - Patients with an Standardized Mini-Mental Test value below 23 were not included. |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Turkey, Mersin University, | Mersin | Turkey/Mersin,Yenisehir |
| Lead Sponsor | Collaborator |
|---|---|
| Mersin University |
Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Physical function will evaluate using Western Ontario and McMaster Universities Osteoarthritis Index | It consists of a total of 24 items including pain (5 items), stiffness (2 items), and physical function (17 items). Items are rated on a five-point Likert scale as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme). The highest possible scores which can be obtained are 20 for pain, 8 for stiffness, and 68 for physical function (difficulties experienced when engaging in ADLs). The total score ranges from 0 (the best) to 96 (the worst). Higher scores indicate worse KF, while lower scores indicate better KF. | Change from before implementation, after, 1st month and 3rd month | |
| Secondary | Quality of life will evaluate using Short Form 36 Quality of Life Scale | This scale measures eight subscales using 36 self-rating questions including physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. While making the evaluation, a total score is obtained for each subscale separately and these scores are ranges from minimum=0 and maximum=100. Higher scores indicate better quality of life, while lower scores indicate worse quality of life. | Change from before implementation, after, 1st month and 3rd month |
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