- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04683588
The Effect of Coaching Strategy on Some Patient Outcomes After Total Knee Arthroplasty Surgery
Effect of Continuous Nursing Care Applied to Total Knee Arthroplasty Patients With Coaching Strategy on Some Patient Outcomes: Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selçuklu
-
Konya, Selçuklu, Turkey, 42000
- Medova Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
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,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: intervention arm
|
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.
|
NO_INTERVENTION: Control arm
Patients in the control group will receive routine postoperative nursing care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Reported pain severity in the first 24 hours after surgery
|
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
|
Reported self-care ability status in the first 24 hours after surgery
|
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
|
Reported self-care ability status in the first 24 hours after surgery
|
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
|
Postoperative will be evaluated 72. hour.
|
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
|
After the outpatient clinic examination evaluation(preoperative); 72. hour after surgery; 15th day after discharge; 45 days after discharge; 90th day after discharge.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Şerife Kurşun, PhD, ŞEYH ŞAMİL NEIGHBORHOOD DOSTELİ AVENUE NO: 52/1 SELÇUKLU / KONYA (BEHİND SELÇUKLU MUNİCİPALİTY)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 93804542-020
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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