NCT04683588

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
26 days until next milestone

Study Start

First participant enrolled

January 19, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2021

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

December 16, 2020

Last Update Submit

May 25, 2022

Conditions

Keywords

Nursing coachingPostoperative careTotal Knee arthroplasty

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • New Castle Nursing Care Satisfaction

    New Castle Nursing Care Satisfaction Scale:1-5 1-Lowest , 5-Highest

    Postoperative will be evaluated 72. hour.

  • 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.

Study Arms (2)

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.

Other: Nursing Coaching

Control arm

NO INTERVENTION

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

Interventions

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.

intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medova Hospital

Konya, Selçuklu, 42000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeAnxiety DisordersPatient SatisfactionMental Disorders

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Şerife Kurşun, PhD

    ŞEYH ŞAMİL NEIGHBORHOOD DOSTELİ AVENUE NO: 52/1 SELÇUKLU / KONYA (BEHİND SELÇUKLU MUNİCİPALİTY)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 24, 2020

Study Start

January 19, 2021

Primary Completion

April 19, 2021

Study Completion

October 28, 2021

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations