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

Primary Purpose

Postoperative Pain, Anxiety, Self Efficacy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Nursing Coaching
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Nursing coaching, Postoperative care, Total Knee arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

  • Medova Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention arm

Control arm

Arm Description

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.

Patients in the control group will receive routine postoperative nursing care.

Outcomes

Primary Outcome Measures

Postoperative pain severity
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain
Postoperative self-care ability scale
Self -care ability scale with score: 0-5; 0-lowest, 5-highest
state anxiety scale
state anxiety scale score :1-4 ; 1-Lowest , 4-Highest
New Castle Nursing Care Satisfaction
New Castle Nursing Care Satisfaction Scale:1-5 1-Lowest , 5-Highest
Modified Barthel index
Modified Barthel index 0-15 0-Lowest, 15 Highest

Secondary Outcome Measures

Full Information

First Posted
December 16, 2020
Last Updated
May 25, 2022
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT04683588
Brief Title
The Effect of Coaching Strategy on Some Patient Outcomes After Total Knee Arthroplasty Surgery
Official Title
Effect of Continuous Nursing Care Applied to Total Knee Arthroplasty Patients With Coaching Strategy on Some Patient Outcomes: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 19, 2021 (Actual)
Primary Completion Date
April 19, 2021 (Actual)
Study Completion Date
October 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Anxiety, Self Efficacy, Patient Satisfaction, Lifestyle-related Condition
Keywords
Nursing coaching, Postoperative care, Total Knee arthroplasty

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Patients in the control group will receive routine postoperative nursing care.
Intervention Type
Other
Intervention Name(s)
Nursing Coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative pain severity
Description
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain
Time Frame
Reported pain severity in the first 24 hours after surgery
Title
Postoperative self-care ability scale
Description
Self -care ability scale with score: 0-5; 0-lowest, 5-highest
Time Frame
Reported self-care ability status in the first 24 hours after surgery
Title
state anxiety scale
Description
state anxiety scale score :1-4 ; 1-Lowest , 4-Highest
Time Frame
Reported self-care ability status in the first 24 hours after surgery
Title
New Castle Nursing Care Satisfaction
Description
New Castle Nursing Care Satisfaction Scale:1-5 1-Lowest , 5-Highest
Time Frame
Postoperative will be evaluated 72. hour.
Title
Modified Barthel index
Description
Modified Barthel index 0-15 0-Lowest, 15 Highest
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şerife Kurşun, PhD
Organizational Affiliation
ŞEYH ŞAMİL NEIGHBORHOOD DOSTELİ AVENUE NO: 52/1 SELÇUKLU / KONYA (BEHİND SELÇUKLU MUNİCİPALİTY)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medova Hospital
City
Konya
State/Province
Selçuklu
ZIP/Postal Code
42000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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