Postoperative PainNCT04683588
The Effect of Coaching Strategy on Some Patient Outcomes After Total Knee Arthroplasty Surgery
A study testing Nursing Coaching in people with Postoperative Pain and Anxiety, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Total knee arthroplasty (TKA); It is frequently applied to adults, especially those over the age of 55. Total knee arthroplasty surgery is among the surgeries with a high satisfaction rate for the patient, although complications can develop and this rate varies between 1.65-11.3%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Anxiety, Self Efficacy
- What is being tested?
- Nursing Coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jan 2021to 28 Oct 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being literate, Turkish speaking and verbal communication, Absence of cognitive diseases such as Alzheimer's, delirium and dementia, No psychiatric problems, Being 18 years or older, Living in Konya city center
Who cannot join
- Having undergone a revision total knee replacement operation, Application of analgesic medication to the knee joint space during surgery, Application of patient controlled analgesia (PCA) in postoperative pain control, Not understanding the content of the research, Having a health problem that prevents exercising or evaluating,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Continuous Nursing Care Applied to Total Knee Arthroplasty Patients With Coaching Strategy on Some Patient Outcomes: Randomized Controlled Trial
Total knee arthroplasty (TKA); It is frequently applied to adults, especially those over the age of 55. Total knee arthroplasty surgery is among the surgeries with a high satisfaction rate for the patient, although complications can develop and this rate varies between 1.65-11.3%. It has a privileged place in the prevention, early diagnosis and treatment of the problems and complications that may occur. In this way, patients' anxiety will be reduced, self-care competence will be provided, recovery process will be accelerated, quality of life and care satisfaction will increase. In this context, the training, information, skill-building, counseling and care practice that the nurse will provide to the patient; With the results to be obtained from this study, patients with TKA can be given pre-operative and post-operative nursing care using a nurse coaching strategy, and patients' anxiety level, pain control, patient satisfaction It is predicted to have a positive effect on self-care ability and re-hospitalization rates. Thus, it is thought that both quality healthcare services will be provided and will contribute to the creation of evidence-based data. It is thought that the study will also contribute to the dissemination of the pre-operative and postoperative nurse coaching strategy in patients undergoing TKA, and will guide the planning of nursing education. This study is an experimental study to determine the effect of continuous nursing care given with a coaching strategy to patients scheduled for TKA surgery on anxiety, pain, self-care ability, satisfaction, and re-hospitalization. The study will be carried out in Konya Private Hospital. Data collection time is set as September-December 2020. Data will be collected by the researcher using the Diagnostic questionnaire form, State Anxiety Scale, Visual Analog Scale, Newcastle Nursing Care Satisfaction Scale, Modified Barthel index and Self-Care Ability Scale. In this context, the training, information, skill-building, counseling and care practice that the nurse will provide to the patient; It will contribute to achieving the desired results by positively affecting both the success of the surgery and the healing process of the patient.
Read the detailed description
The universe of the research; patients who are planned to undergo total knee arthroplasty between January 1, 2021 and June 1, 2021 in the orthopedic surgery clinic where the study will be conducted will comprise the patients who meet the inclusion criteria and agree to participate in the study. The research was planned as a randomized controlled experimental study. Block randomization method will be used to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program (www.randomizer.org) will be used. Randomization will be done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list. Research data will be collected in a hospital's orthopedics and traumatology service surgery ward between 1 January 2021 - 1 June 2021.
The dependent variables of the study are postoperative statue anxiety score, patient self-care ability score, pain severity (Visual Analog Scale-VAS), pain control and status ( pain-causing conditions, analgesic such as use case), patient satisfaction score, re-hospitalization average. In the research, "Individual Characteristics Form" and "Patient Follow-up Form" prepared by the researcher in line with the literature will be used as data collection tools.
- Conditions
- Postoperative Pain, Anxiety, Self Efficacy, Patient Satisfaction, Lifestyle-related Condition
- Being tested
- Nursing Coaching
- Keywords
- Nursing coaching, Postoperative care, Total Knee arthroplasty
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders, Patient Satisfaction, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing CoachingOther
Different strategies, methods and training techniques are used in the implementation of preoperative and postoperative nursing care of surgical patients scheduled for total knee arthroplasty surgery. One of them is patient coaching. Coaching is a method that increases the quality of nursing care.While the coaching strategy contributes more to the recovery process of the patient with the role of the case manager of the nurse, it provides a reduction in the problems related to surgery (pain, nausea-vomiting, mobilization problems), reduction in repeated hospitalizations and positive contributions to the cost.
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | 1. Polyclinic: Pre-tests (pain, anxiety, self-care and daily living activities), General coaching, 60 minutes
2. Before Surgery: Nursing coaching, 30-45 minutes
3. Surgery Day: Nursing coaching, 30-45 minutes
4. Postoperative 1st Day: Nursing coaching, 30-45 minutes
5. Postoperative 2nd Day: Nursing coaching practice, 30-45 minutes
6. Day of discharge: Nursing coaching, 30-45 minutes.
7. 15 days after discharge: Nursing coaching, 60 minutes
8. 45 days after the operation: Nursing coaching, 60 minutes.
9. 90 days after surgery: Nursing coaching, 60 minutes. Receives: Other: Nursing Coaching |
| Control arm | No intervention | Patients in the control group will receive routine postoperative nursing care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain severity
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain
Measured: Reported pain severity in the first 24 hours after surgery
Postoperative self-care ability scale
Self -care ability scale with score: 0-5; 0-lowest, 5-highest
Measured: Reported self-care ability status in the first 24 hours after surgery
state anxiety scale
state anxiety scale score :1-4 ; 1-Lowest , 4-Highest
Measured: Reported self-care ability status in the first 24 hours after surgery
New Castle Nursing Care Satisfaction
New Castle Nursing Care Satisfaction Scale:1-5 1-Lowest , 5-Highest
Measured: Postoperative will be evaluated 72. hour.
Modified Barthel index
Modified Barthel index 0-15 0-Lowest, 15 Highest
Measured: After the outpatient clinic examination evaluation(preoperative); 72. hour after surgery; 15th day after discharge; 45 days after discharge; 90th day after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start19 Jan 2021
- Primary completion19 Apr 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- The study was planned as a randomized controlled study to determine the pre- and postoperative nursing care patients' anxiety level, pain control, self-care capacity, nursing care service and hospital re-hospitalization in patients who underwent total knee prosthesis
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Durmaz, Selcuk University
- Investigators
- Şerife Kurşun, PhD, Principal investigator, ŞEYH ŞAMİL NEIGHBORHOOD DOSTELİ AVENUE NO: 52/1 SELÇUKLU / KONYA (BEHİND SELÇUKLU MUNİCİPALİTY)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683588
- Sponsor's protocol ID
- 93804542-020
- Status last verified
- May 2022
- First submitted
- 16 Dec 2020
- Last updated
- 26 May 2022
- 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 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Nursing Care Applied to Total Knee Arthroplasty Patients With Coaching Strategy on Some Patient Outcomes: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04683588
- Acronym / sponsor ID
- 93804542-020
- Conditions
- Postoperative Pain, Anxiety, Self Efficacy, Patient Satisfaction, Lifestyle-related Condition
- Keywords
- Nursing coaching, Postoperative care, Total Knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 19 Apr 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 24 Dec 2020 (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 arthroplasty (TKA); It is frequently applied to adults, especially those over the age of 55. Total knee arthroplasty surgery is among the surgeries with a high satisfaction rate for the patient, although complications can develop and this rate varies between 1.65-11.3%. It has a privileged place in the prevention, early diagnosis and treatment of the problems and complications that may occur. In this way, patients' anxiety will be reduced, self-care competence will be provided, recovery process will be accelerated, quality of life and care satisfaction will increase. In this context, the training, information, skill-building, counseling and care practice that the nurse will provide to the patient; With the results to be obtained from this study, patients with TKA can be given pre-operative and post-operative nursing care using a nurse coaching strategy, and patients' anxiety level, pain control, patient satisfaction It is predicted to have a positive effect on self-care ability and re-hospitalization rates. Thus, it is thought that both quality healthcare services will be provided and will contribute to the creation of evidence-based data. It is thought that the study will also contribute to the dissemination of the pre-operative and postoperative nurse coaching strategy in patients undergoing TKA, and will guide the planning of nursing education. This study is an experimental study to determine the effect of continuous nursing care given with a coaching strategy to patients scheduled for TKA surgery on anxiety, pain, self-care ability, satisfaction, and re-hospitalization. The study will be carried out in Konya Private Hospital. Data collection time is set as September-December 2020. Data will be collected by the researcher using the Diagnostic questionnaire form, State Anxiety Scale, Visual Analog Scale, Newcastle Nursing Care Satisfaction Scale, Modified Barthel index and Self-Care Ability Scale. In this context, the training, information, skill-building, counseling and care practice that the nurse will provide to the patient; It will contribute to achieving the desired results by positively affecting both the success of the surgery and the healing process of the patient.
Detailed description
The universe of the research; patients who are planned to undergo total knee arthroplasty between January 1, 2021 and June 1, 2021 in the orthopedic surgery clinic where the study will be conducted will comprise the patients who meet the inclusion criteria and agree to participate in the study. The research was planned as a randomized controlled experimental study. Block randomization method will be used to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program (www.randomizer.org) will be used. Randomization will be done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list. Research data will be collected in a hospital's orthopedics and traumatology service surgery ward between 1 January 2021 - 1 June 2021.
The dependent variables of the study are postoperative statue anxiety score, patient self-care ability score, pain severity (Visual Analog Scale-VAS), pain control and status ( pain-causing conditions, analgesic such as use case), patient satisfaction score, re-hospitalization average. In the research, "Individual Characteristics Form" and "Patient Follow-up Form" prepared by the researcher in line with the literature will be used as data collection tools.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was planned as a randomized controlled study to determine the pre- and postoperative nursing care patients' anxiety level, pain control, self-care capacity, nursing care service and hospital re-hospitalization in patients who underwent total knee prosthesis
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Other: Nursing Coaching1. Polyclinic: Pre-tests (pain, anxiety, self-care and daily living activities), General coaching, 60 minutes 2. Before Surgery: Nursing coaching, 30-45 minutes 3. Surgery Day: Nursing coaching, 30-45 minutes 4. Postoperative 1st Day: Nursing coaching, 30-45 minutes 5. Postoperative 2nd Day: Nursing coaching practice, 30-45 minutes 6. Day of discharge: Nursing coaching, 30-45 minutes. 7. 15 days after discharge: Nursing coaching, 60 minutes 8. 45 days after the operation: Nursing coaching, 60 minutes. 9. 90 days after surgery: Nursing coaching, 60 minutes. |
| Control arm | No intervention | –Patients in the control group will receive routine postoperative nursing care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being literate, Turkish speaking and verbal communication, Absence of cognitive diseases such as Alzheimer's, delirium and dementia, No psychiatric problems, Being 18 years or older, Living in Konya city center
Key exclusion criteria (1 listed)
- Having undergone a revision total knee replacement operation, Application of analgesic medication to the knee joint space during surgery, Application of patient controlled analgesia (PCA) in postoperative pain control, Not understanding the content of the research, Having a health problem that prevents exercising or evaluating,
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 |
|---|---|---|
| Nursing CoachingDifferent strategies, methods and training techniques are used in the implementation of preoperative and postoperative nursing care of surgical patients scheduled for total knee arthroplasty surgery. One of them is patient coaching. Coaching is a method that increases the quality of nursing care.While the coaching strategy contributes more to the recovery process of the patient with the role of the case manager of the nurse, it provides a reduction in the problems related to surgery (pain, nausea-vomiting, mobilization problems), reduction in repeated hospitalizations and positive contributions to the cost. | Other | intervention arm |
Primary outcome
Postoperative pain severity
Time frame: Reported pain severity in the first 24 hours after surgery
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain
Postoperative self-care ability scale
Time frame: Reported self-care ability status in the first 24 hours after surgery
Self -care ability scale with score: 0-5; 0-lowest, 5-highest
state anxiety scale
Time frame: Reported self-care ability status in the first 24 hours after surgery
state anxiety scale score :1-4 ; 1-Lowest , 4-Highest
New Castle Nursing Care Satisfaction
Time frame: Postoperative will be evaluated 72. hour.
New Castle Nursing Care Satisfaction Scale:1-5 1-Lowest , 5-Highest
Modified Barthel index
Time frame: After the outpatient clinic examination evaluation(preoperative); 72. hour after surgery; 15th day after discharge; 45 days after discharge; 90th day after discharge.
Modified Barthel index 0-15 0-Lowest, 15 Highest
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 26 May 2022.
- 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.
Şerife Kurşun, PhD principal investigator
ŞEYH ŞAMİL NEIGHBORHOOD DOSTELİ AVENUE NO: 52/1 SELÇUKLU / KONYA (BEHİND SELÇUKLU MUNİCİPALİTY)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Coaching in people with Postoperative Pain and Anxiety, run by Selcuk 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 1 inclusion and 1 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 26 May 2022. 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?
Postoperative pain severity (time frame: Reported pain severity in the first 24 hours after surgery). The study lists 5 primary outcomes in all. 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 26 May 2022.