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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04683588
Other study ID # 93804542-020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 19, 2021
Est. completion date October 28, 2021

Study information

Verified date May 2022
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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%. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date October 28, 2021
Est. primary completion date April 19, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Nursing Coaching
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.

Locations

Country Name City State
Turkey Medova Hospital Konya Selçuklu

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain severity 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
Primary Postoperative self-care ability scale Self -care ability scale with score: 0-5; 0-lowest, 5-highest Reported self-care ability status in the first 24 hours after surgery
Primary state anxiety scale state anxiety scale score :1-4 ; 1-Lowest , 4-Highest Reported self-care ability status in the first 24 hours after surgery
Primary New Castle Nursing Care Satisfaction New Castle Nursing Care Satisfaction Scale:1-5 1-Lowest , 5-Highest Postoperative will be evaluated 72. hour.
Primary Modified Barthel index 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.
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