Prosthesis-Related InfectionsNCT06521073
Educatıon in Patıents Who Had Total Knee Prosthesıs
A study testing education in people with Prosthesis-Related Infections and Pain, Postoperative, run by Cukurova University.
Trial summary
The main purposes of nursing care and education for patients who will undergo total knee prosthesis are; The aim is to reduce pain, prevent complications that may develop due to orthopedic surgery, increase patient satisfaction, and preserve function and mobilization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthesis-Related Infections, Pain, Postoperative, Analgesia
- What is being tested?
- education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Sep 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 age over
- Being literate,
- Having knee replacement surgery for the first time;
- Not having chronic diseases or psychiatric diagnoses that would delay wound healing,
- Except hypertension;
- İt will include not developing any early complicationsthe research was planned to be carried out in three stages.
Who cannot join
- Hospitalized for at least 24 hours
- Agreeing to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Traınıng on Paın, Actıvıtıes of Daıly Lıfe and Patıent Satısfactıon in Patıents Who Had Total Knee Prosthesıs
The main purposes of nursing care and education for patients who will undergo total knee prosthesis are; The aim is to reduce pain, prevent complications that may develop due to orthopedic surgery, increase patient satisfaction, and preserve function and mobilization.
Read the detailed description
The knee joint is one of the largest joints in the body and is responsible for maintaining mobilization. This joint is treated with surgery in cases where medical treatment and physiotherapy are ineffective and pain and loss of function increase. For this reason, degenerative diseases of the knee joint are mostly treated with Total Knee Prosthesis (TKA) surgery. TKA is a surgical intervention that reconstructs the joint in patients with knee osteoarthritis, in order to reduce pain and regain lost functions in cases where there is no response to conservative treatment.
TKA is applied to patients whose daily activities are restricted due to pain, limitation of movement, deformity and instability and who cannot achieve the expected improvement with conservative treatment methods (2-4). However, after TKA, life-threatening physical and functional problems and complications that reduce the quality of life and such as pain, infection, pretibial edema, deterioration in bowel functions, pulmonary embolism (PE), deep vein thrombosis (DVT) and prosthesis dislocation may develop.
Early diagnosis and treatment of physical and psychological problems that may occur in these patients, and provision of qualified training that supports patients; self-care competence and functions will accelerate the recovery process and increase the quality of life and patient satisfaction. In a study evaluating health care needs in the early period after TKA. Regarding reducing the pain of patients before discharge, rehabilitation exercises, wound monitoring and care; It has been determined that there is an expectation to be informed about the problems that may occur after discharge, things to pay attention to in the home environment, activities that should not be done, and check-up times.
The main purposes of nursing care and education for patients who will undergo total knee prosthesis are; The aim is to reduce pain, prevent complications that may develop due to orthopedic surgery, increase patient satisfaction, and preserve function and mobilization. It is the nurses duty to determine the patients needs, help the patient when necessary, and ensure continuity of care in cooperation with the patient, his family and the healthcare team. For this reason, nursing care should support the patient and his family until they are equipped with the necessary strength, desire and knowledge, and in this way, individuals should help the patient and their family to gain their independence as soon as possible.
- Being tested
- education
- Keywords
- education, pain, Total Knee Prosthesis
- Medical subject headings
- Prosthesis-Related Infections, Pain, Postoperative, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationBehavioural
Patient Information Form (HBF): This form, prepared by scanning the literature, includes the patient\'s age, gender, marital status, education level, profession, social security, place of residence, presence of caregivers in the family, from whom he/she receives care, chronic diseases, the side on which knee prosthesis is applied, knee prosthesis. It is a form consisting of questions about your training status, who you received your training from, and your satisfaction with the training.
Barthel Index (BI): Barthel activities of daily living index is an evaluation scale used to measure an individual\'s performance in daily living activities. The index is used for activities of daily living in 10 domains. The Turkish validity and reliability of the Barthel index, developed by Barthel and Mahoney (1965), was determined by Küçükdeveci et al. (17).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Before Surgery HBF ONE SAO Patient Education Material Post-Operation (1st, 2nd, 3rd day) ONE SAO Patient Education Material 10-14. BI and PSA will be applied on days and 6 weeks. Receives: Behavioral: education |
| Control | No intervention | Before Surgery HBF ONE SAO Routine verbal training of the clinic Post-Operation (1st, 2nd, 3rd day) ONE SAO Routine verbal training of the clinic 10-14. BI and PSA will be applied on days and 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Patient Information Form (PIF) This form, prepared by scanning the literature, includes the patient's age, gender, marital status, education level, profession, social security, place of residence, presence of caregivers in the family, from whom he/she receives care, chronic diseases, the side on which knee prosthesis is applied, knee prosthesis. It is a form consisting of questions about your training status, who you received your training from, and your satisfaction with the training.
Measured: 1 week
Secondary outcomes (1)
Secondary Outcome Measures
Barthel Index (BI):
Barthel activities of daily living index is an evaluation scale used to measure an individual's performance in daily living activities. The index is used for activities of daily living in 10 domains. This scale, which questions nutrition, washing, self-care, dressing, bowel control, bladder control, toilet use, the ability to move from a wheelchair to a bed and vice versa, mobility and going up and down stairs, consists of a total of 10 items rated on a 0-15 point scale. In this scale, where the possible score ranges from 0 to 100, the high score means the degree to which the individual can function independently (0-20 points are fully dependent, 21-61 points are highly dependent, 62-90 points are moderately dependent, 91-99 points are mildly dependent). dependent, 100 points completely independent).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis-Related InfectionsStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur tura, Cukurova University
- Investigators
- sevban arslan, Study director, Cukurova Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521073
- Sponsor's protocol ID
- 06.01.2024/129
- Status last verified
- Jul 2024
- First submitted
- 14 Jun 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Traınıng on Paın, Actıvıtıes of Daıly Lıfe and Patıent Satısfactıon in Patıents Who Had Total Knee Prosthesıs
- ClinicalTrials.gov ID
- NCT06521073
- Acronym / sponsor ID
- 06.01.2024/129
- Keywords
- education, pain, Total Knee Prosthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 25 Jul 2024 (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.
The main purposes of nursing care and education for patients who will undergo total knee prosthesis are; The aim is to reduce pain, prevent complications that may develop due to orthopedic surgery, increase patient satisfaction, and preserve function and mobilization.
Detailed description
The knee joint is one of the largest joints in the body and is responsible for maintaining mobilization. This joint is treated with surgery in cases where medical treatment and physiotherapy are ineffective and pain and loss of function increase. For this reason, degenerative diseases of the knee joint are mostly treated with Total Knee Prosthesis (TKA) surgery. TKA is a surgical intervention that reconstructs the joint in patients with knee osteoarthritis, in order to reduce pain and regain lost functions in cases where there is no response to conservative treatment.
TKA is applied to patients whose daily activities are restricted due to pain, limitation of movement, deformity and instability and who cannot achieve the expected improvement with conservative treatment methods (2-4). However, after TKA, life-threatening physical and functional problems and complications that reduce the quality of life and such as pain, infection, pretibial edema, deterioration in bowel functions, pulmonary embolism (PE), deep vein thrombosis (DVT) and prosthesis dislocation may develop.
Early diagnosis and treatment of physical and psychological problems that may occur in these patients, and provision of qualified training that supports patients; self-care competence and functions will accelerate the recovery process and increase the quality of life and patient satisfaction. In a study evaluating health care needs in the early period after TKA. Regarding reducing the pain of patients before discharge, rehabilitation exercises, wound monitoring and care; It has been determined that there is an expectation to be informed about the problems that may occur after discharge, things to pay attention to in the home environment, activities that should not be done, and check-up times.
The main purposes of nursing care and education for patients who will undergo total knee prosthesis are; The aim is to reduce pain, prevent complications that may develop due to orthopedic surgery, increase patient satisfaction, and preserve function and mobilization. It is the nurses duty to determine the patients needs, help the patient when necessary, and ensure continuity of care in cooperation with the patient, his family and the healthcare team. For this reason, nursing care should support the patient and his family until they are equipped with the necessary strength, desire and knowledge, and in this way, individuals should help the patient and their family to gain their independence as soon as possible.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: educationBefore Surgery HBF ONE SAO Patient Education Material Post-Operation (1st, 2nd, 3rd day) ONE SAO Patient Education Material 10-14. BI and PSA will be applied on days and 6 weeks. |
| Control | No intervention | –Before Surgery HBF ONE SAO Routine verbal training of the clinic Post-Operation (1st, 2nd, 3rd day) ONE SAO Routine verbal training of the clinic 10-14. BI and PSA will be applied on days and 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 age over
- Being literate,
- Having knee replacement surgery for the first time;
- Not having chronic diseases or psychiatric diagnoses that would delay wound healing,
- Except hypertension;
Key exclusion criteria (2 listed)
- Hospitalized for at least 24 hours
- Agreeing to participate in the study
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 |
|---|---|---|
| educationPatient Information Form (HBF): This form, prepared by scanning the literature, includes the patient\'s age, gender, marital status, education level, profession, social security, place of residence, presence of caregivers in the family, from whom he/she receives care, chronic diseases, the side on which knee prosthesis is applied, knee prosthesis. It is a form consisting of questions about your training status, who you received your training from, and your satisfaction with the training. Barthel Index (BI): Barthel activities of daily living index is an evaluation scale used to measure an individual\'s performance in daily living activities. The index is used for activities of daily living in 10 domains. The Turkish validity and reliability of the Barthel index, developed by Barthel and Mahoney (1965), was determined by Küçükdeveci et al. (17). | Behavioural | Experimental |
Primary outcome
Primary Outcome Measure
Time frame: 1 week
Patient Information Form (PIF) This form, prepared by scanning the literature, includes the patient's age, gender, marital status, education level, profession, social security, place of residence, presence of caregivers in the family, from whom he/she receives care, chronic diseases, the side on which knee prosthesis is applied, knee prosthesis. It is a form consisting of questions about your training status, who you received your training from, and your satisfaction with the training.
1 secondary outcome
Secondary Outcome Measures
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
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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.
sevban arslan study director
Cukurova Universty
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Prosthesis-Related Infections and Pain, Postoperative, run by Cukurova University.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ilknur tura, MsC (+903223386084, itura@cu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 1 week). 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 25 Jul 2024.