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
About this trial
This is an interventional other trial for Knee Osteoarthritis
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
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
NCT ID
NCT05178615
First Posted
December 1, 2021
Last Updated
January 4, 2022
Sponsor
Hacettepe University
Collaborators
Saglik Bilimleri Universitesi
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
Learn more about this trial
Investigation of the Effect of Preoperative Education on Postoperative Outcomes in Total Knee Arthroplasty Patients
We'll reach out to this number within 24 hrs