- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05178615
Investigation of the Effect of Preoperative Education on Postoperative Outcomes in Total Knee Arthroplasty Patients
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
Six minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-344
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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