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

Primary Purpose

Knee Osteoarthritis, Pain, Postoperative, Kinesiophobia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
preoperative education
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Education group

    control

    Arm Description

    Preoperative education

    Traditionally care

    Outcomes

    Primary Outcome Measures

    Pain Beliefs Questionnaire
    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.
    Tampa Scale of Kinesiophoby
    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.

    Secondary Outcome Measures

    Hospital Anxiety and Depression Scale
    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.
    Numerical Pain Rating Scale
    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.
    Patient satisfaction
    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: "Are you satisfied with your current mobility?" "Are you satisfied with your current pain situation?" "Are you satisfied with your current knee movements?" "Are you satisfied with the current pain level according to your expectations before the operation?" "Are you satisfied with the information about the post-operative period?" "Are you satisfied with your sleep quality after the operation?" "Are you satisfied with the treatment as a whole?"

    Full Information

    First Posted
    December 1, 2021
    Last Updated
    January 4, 2022
    Sponsor
    Hacettepe University
    Collaborators
    Saglik Bilimleri Universitesi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05178615
    Brief Title
    Investigation of the Effect of Preoperative Education on Postoperative Outcomes in Total Knee Arthroplasty Patients
    Official Title
    Investigation of the Effect of Preoperative Education on Postoperative Outcomes in Total Knee Arthroplasty Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2022 (Anticipated)
    Primary Completion Date
    February 1, 2023 (Anticipated)
    Study Completion Date
    February 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University
    Collaborators
    Saglik Bilimleri Universitesi

    4. Oversight

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

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis, Pain, Postoperative, Kinesiophobia

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Education group
    Arm Type
    Experimental
    Arm Description
    Preoperative education
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    Traditionally care
    Intervention Type
    Other
    Intervention Name(s)
    preoperative education
    Intervention Description
    Education about knee anatomy, patophysiology, total knee arthroplasty surgery, pain neurophysiology, management of pain, the importance of exercise
    Primary Outcome Measure Information:
    Title
    Pain Beliefs Questionnaire
    Description
    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.
    Time Frame
    five minutes
    Title
    Tampa Scale of Kinesiophoby
    Description
    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.
    Time Frame
    Five minutes
    Secondary Outcome Measure Information:
    Title
    Hospital Anxiety and Depression Scale
    Description
    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.
    Time Frame
    Five minutes
    Title
    Numerical Pain Rating Scale
    Description
    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.
    Time Frame
    One minute
    Title
    Patient satisfaction
    Description
    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: "Are you satisfied with your current mobility?" "Are you satisfied with your current pain situation?" "Are you satisfied with your current knee movements?" "Are you satisfied with the current pain level according to your expectations before the operation?" "Are you satisfied with the information about the post-operative period?" "Are you satisfied with your sleep quality after the operation?" "Are you satisfied with the treatment as a whole?"
    Time Frame
    Six minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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