Investigation of the Effect of Preoperative Education on Postoperative Outcomes in Total Knee Arthroplasty Patients

January 4, 2022 updated by: Senem Demirdel, Hacettepe University
Total knee arthroplasty surgery is a common surgical procedure used in the treatment of patients in the end stages of osteoarthritis. Arthroplasty surgery is a process that creates physical and psychological stress on the patient. Preoperative education can reduce anxiety and improve postoperative outcomes. In the studies on education in the literature, it is seen that there are trainings in the form of seminars, trainings made with video recordings, trainings in the form of brochures. Studies in the literature have shown that training given synchronously (live) by a healthcare professional is more effective in reducing anxiety in one-on-one or small-person groups. Less anxiety does not significantly reduce pain levels, but improves patients' ability to cope with pain and increases their perception of preparedness. Together, these two factors can improve patients' overall experience by increasing their sense of control and comfort.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Detailed Description

Studies in the literature define pre-operative education as any educational intervention that aims to improve people's knowledge, health behaviors, and health outcomes before surgery. A 2014 Cochrane© review concluded that pre-operative education provides benefits over standard patient care for hip or knee arthroplasty.

The content of pre-operative education varies, but typical educational materials include information on pre-operative processes, actual steps in the surgical procedure, discharge status, post-operative care, possible surgical and non-surgical complications, answers to frequently asked questions, postoperative pain. The training format consists of one-on-one oral communication, patient group sessions, and a video or booklet. Due to the pandemic process, telerehabilitation methods have become widespread recently. Total knee arthroplasty preoperative trainings conducted to date have been shown to be effective in the form of training given to few people or one-on-one conversations. But to minimize the risk of Covid-19, online education seems to make sense. Researches generally focus on the post-surgical period. However, while the studies emphasized the importance of preoperative education, The investigators did not find any synchronous education in the literature.

Patient satisfaction after joint replacement was found to be directly proportional to meeting expectations for functional outcome and pain. Education given in the preoperative period can affect patient satisfaction by influencing attitudes about patient expectations and pain.

Psychological status has also been reported to be associated with functional outcomes in total knee arthroplasty patients. Fear of movement is an important condition that affects the functionality and recovery of the patient. It has been reported that fear of movement (kinesiophobia) affects early postoperative functional outcomes in total knee arthroplasty patients. Postoperative applications have been shown to be effective on kinesiophobia. However, the investigators could not find any study examining the effect of preoperative education on postoperative outcomes.

The aim of the study is to examine the effect of preoperative education intervention on postoperative pain level, pain beliefs, anxiety and depression, satisfaction, kinesiophobia in total knee arthroplasty patients.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of noninflammatory arthritis
  • Being the first to undergo Total knee arthroplasty surgery,

Exclusion Criteria:

  • Lower extremity surgery in the last 1 year,
  • Body mass index of 40 and above,
  • Revision surgery
  • Single compartment replacement
  • Psychiatric illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education group
Preoperative education
Education about knee anatomy, patophysiology, total knee arthroplasty surgery, pain neurophysiology, management of pain, the importance of exercise
No Intervention: control
Traditionally care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Beliefs Questionnaire
Time Frame: five minutes
It contains 12 items related to pain beliefs. PBQ-O is an 8-item subscale, and PBQ-P is a 4-item subscale. The organic subscale reflects predominantly organic aspects of pain, with items such as "pain is a result of damage to body tissues" or "experiencing pain is a sign that something is wrong with the body", while the psychological beliefs scale predominantly reflects organic aspects of pain. Reflects the influence of psychological factors on pain, with items such as "worrying makes the pain worse" or "thinking about the pain makes it worse" This assessment will be applied prior to the education given in the pre-operative period. It will be reapplied on the day of discharge in the postoperative period to measure the change after education.
five minutes
Tampa Scale of Kinesiophoby
Time Frame: Five minutes
It is a 17-item scale used to measure fear of movement/re-injury. The scale is used to measure injury/re-injury and fear/avoidance parameters in work-related activities. his assessment will be applied prior to the education given in the pre-operative period. It will be reapplied on the day of discharge in the postoperative period to measure the change after education.
Five minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale
Time Frame: Five minutes
HAD is a 14-item questionnaire that reliably detects depression and anxiety in a hospital outpatient clinic. his assessment will be applied prior to the education given in the pre-operative period. It will be reapplied on the day of discharge in the postoperative period to measure the change after education.
Five minutes
Numerical Pain Rating Scale
Time Frame: One minute
Numerical Pain Rating Scale will be used for evaluation of knee pain. On this scale, the severity of pain is graded from 0 to 10. "0" means no pain, "10" means maximum pain. As the score increases, the severity of the pain also increases.This assessment will be applied prior to the education given in the pre-operative period. It will be reapplied on the day of discharge in the postoperative period to measure the change after education.
One minute
Patient satisfaction
Time Frame: Six minutes

Patient satisfaction will be evaluated with expressions created by reviewing the expressions used to evaluate the satisfaction of patients who have previously undergone Total knee arthroplasty.To assess satisfaction, 7 items created by the authors will be scored with a 4-level Likert scale (1=Not at all satisfied, 2=Not satisfied, 3=Satisfied, 4=Very satisfied). The items that evaluate satisfaction are as follows:

  1. "Are you satisfied with your current mobility?"
  2. "Are you satisfied with your current pain situation?"
  3. "Are you satisfied with your current knee movements?"
  4. "Are you satisfied with the current pain level according to your expectations before the operation?"
  5. "Are you satisfied with the information about the post-operative period?"
  6. "Are you satisfied with your sleep quality after the operation?"
  7. "Are you satisfied with the treatment as a whole?"
Six minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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