The Effect of Coaching Strategy on Some Patient Outcomes After Total Knee Arthroplasty Surgery

• ClinicalTrials.gov Identifier: NCT04683588
• Recruitment Status: Recruiting
• First Posted: December 24, 2020
• Last Update Posted: January 5, 2022
• Sponsor: Selcuk University
• Information provided by (Responsible Party): Melike Durmaz, Selcuk University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain; Anxiety; Self Efficacy; Patient Satisfaction; Lifestyle-related Condition	Other: Nursing Coaching	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effect of Continuous Nursing Care Applied to Total Knee Arthroplasty Patients With Coaching Strategy on Some Patient Outcomes: Randomized Controlled Trial
• Actual Study Start Date: April 30, 2021
• Actual Primary Completion Date: October 30, 2021
• Estimated Study Completion Date: December 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: intervention arm; Polyclinic: Pre-tests (pain, anxiety, self-care and daily living activities), General coaching, 60 minutes; Before Surgery: Nursing coaching, 30-45 minutes; Surgery Day: Nursing coaching, 30-45 minutes; Postoperative 1st Day: Nursing coaching, 30-45 minutes; Postoperative 2nd Day: Nursing coaching practice, 30-45 minutes; Day of discharge: Nursing coaching, 30-45 minutes.; 15 days after discharge: Nursing coaching, 60 minutes; 45 days after the operation: Nursing coaching, 60 minutes.; 90 days after surgery: Nursing coaching, 60 minutes.	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.
No Intervention: Control arm; Patients in the control group will receive routine postoperative nursing care.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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
4. 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
5. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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,

Contacts and Locations

Contacts

Contact: Melike DURMAZ, MsC; +905055884006; melikedurmaz@selcuk.edu.tr

Contact: Şerife KURŞUN, Prof (Asst); +905052156226; serifekursun@hotmail.com

Locations

Turkey

Medova Hospital; Recruiting

Konya, Selçuklu, Turkey, 42000

Contact: Ümmühan KURT, MsC 05056500276 ummuhan.kurt@medova.com

Sponsors and Collaborators

Selcuk University

Investigators

• Principal Investigator: Şerife Kurşun, PhD; ŞEYH ŞAMİL NEIGHBORHOOD DOSTELİ AVENUE NO: 52/1 SELÇUKLU / KONYA (BEHİND SELÇUKLU MUNİCİPALİTY)

More Information

• Responsible Party: Melike Durmaz, Nurse, Selcuk University
• ClinicalTrials.gov Identifier: NCT04683588
• Other Study ID Numbers: 93804542-020
• First Posted: December 24, 2020
• Last Update Posted: January 5, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Melike Durmaz, Selcuk University:

Nursing coaching; Postoperative care; Total Knee arthroplasty

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations