Quality of LifeNCT04924049
Video-Assisted Education for Patients With Knee Replacement
A study testing Video-assisted education in people with Quality of Life, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 33 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Video-assisted education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 1 Aug 2019
- 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 33 to 81 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turkey, Mersin University,
Mersin, Turkey/Mersin,Yenişehir, 33343
About this study
Official title: Video-Assisted Education for Patients With Knee Replacement: Knee Function and Quality of Life
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.
Read the 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.
- Conditions
- Quality of Life
- Being tested
- Video-assisted education
- Keywords
- Knee Function, Quality of Life, Surgical Nursing, Video-Assisted Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-assisted educationOther
Also called Education
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Video-assisted education |
| Control | No intervention | The control group received routine treatment and care per protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from before implementation, after, 1st month and 3rd month
Secondary outcomes (1)
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.
Measured: Change from before implementation, after, 1st month and 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Jul 2018
- Primary completion30 Mar 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm \[1:1\], parallel group, prospective, randomized-controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulay ALTUN UGRAS, Mersin University
- Investigators
- Gulay Altun Ugras, Doctorate, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924049
- Sponsor's protocol ID
- Mersin University Surgical
- Status last verified
- Jun 2021
- First submitted
- 7 Jun 2021
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-Assisted Education for Patients With Knee Replacement: Knee Function and Quality of Life
- ClinicalTrials.gov ID
- NCT04924049
- Acronym / sponsor ID
- Mersin University Surgical
- Conditions
- Quality of Life
- Keywords
- Knee Function, Quality of Life, Surgical Nursing, Video-Assisted Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm [1:1], parallel group, prospective, randomized-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Video-assisted educationThe 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). |
| Control | No intervention | –The control group received routine treatment and care per protocol. |
Who may qualify
- Ages
- 33 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-assisted educationAlso: EducationPrior 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 | Experimental |
Primary outcome
Physical function will evaluate using Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Change from before implementation, after, 1st month and 3rd month
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Quality of Life
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Active, not recruitingPhase 2
Single Fraction or Multi-fraction Palliative Radiation Therapy for the Improvement of Quality of Life in Patients With Metastatic Gynecologic Cancers
Metastatic Malignant Female Reproductive System Neoplasm
Not yet recruiting
Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome
Premenstrual Syndrome
Active, not recruiting
App-Based Mindfulness Intervention for the Improvement of Quality of Life in Patients With Metastatic Renal Cell Cancer
Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
Active, not recruiting
Acceptance and Commitment Therapy-Based Group Psychotherapy for Chronic Headache
Chronic Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulay Altun Ugras, Doctorate study director
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-assisted education in people with Quality of Life, run by Mersin 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 10 inclusion and 11 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 16 Jun 2021. 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?
Physical function will evaluate using Western Ontario and McMaster Universities Osteoarthritis Index (time frame: Change from before implementation, after, 1st month and 3rd month). 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 16 Jun 2021.