- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04924049
Video-Assisted Education for Patients With Knee Replacement
Video-Assisted Education for Patients With Knee Replacement: Knee Function and Quality of Life
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A comprehensive nursing care and patient education are essential to gain independence and return ADLs for patients undergoing TKR. Patient education after TKR increases the success of the operation, improving the healing period, and preventing or minimizing postoperative complications after discharge. All these improve the KF and QoL of the patients. Patients are usually discharged on the first postoperative day, if no complication occurs. Thus, the patient education can be instructed within a very limited period of time, mostly without repetition. Furthermore, patients and/or their relatives may be anxious after TKR and before discharge, leading to difficulties in understanding the education fully or remembering the education given in the hospital. As a result, the use of new technological education tools is inevitable to use the time effectively for nurses.
In recent years, disease-specific video-assisted education (VE) has been increasingly used for patient education. This tool has certain advantages that patients can watch the video repeatedly in every setting, until they understand its content and can remember the content than verbal instructions without limitations of recall memory with decreased anxiety and improved self-care abilities and, eventually, improved patient outcomes . In the present study, we hypothesized that VE could improve the KF and QoL following TKR. Using a holistic approach, we, therefore, aimed to investigate the effect of VE on KF and QoL in patients undergoing TKR.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Turkey/Mersin,Yenişehir
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Mersin, Turkey/Mersin,Yenişehir, Turkey, 33343
- Turkey, Mersin University,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Experimental
The video-assisted education group also received routine treatment and care per protocol.
Additionally, this patient group watched patient education through video in the patient room before TKR.
The contents of the VE were developed by the researchers and included early postoperative care for TKR (knee positioning, early mobilization, pain control, and cold application), ADLs at home (bathing and toileting, eating, sleeping, vehicle driving, housekeeping, sexual life, praying, and maintaining home safety), and gradual exercise at home (for the first 90 days after discharge).
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Prior the study, the content and comprehensibility of the VE were evaluated by an orthopedic surgeon, two orthopedic nurses, and a physiotherapist who were not involved in the study and relevant amendments were made based on their suggestions.
The preview of the final version of the VE was shown to four patients (10% of the sample) and these patients were excluded from the study.
The patients were interviewed by phone calls on a weekly basis and watching VE at home, the frequency of watching VE, and doing home-based exercises were questioned.
Other Names:
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No Intervention: Control
The control group received routine treatment and care per protocol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical function will evaluate using Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: Change from before implementation, after, 1st month and 3rd month
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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.
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Change from before implementation, after, 1st month and 3rd month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life will evaluate using Short Form 36 Quality of Life Scale
Time Frame: Change from before implementation, after, 1st month and 3rd month
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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.
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Change from before implementation, after, 1st month and 3rd month
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gülay Altun Uğraş, doctorate, Mersin University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Mersin University Surgical
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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