Knee OsteoarthritisNCT05178615
Investigation of the Effect of Preoperative Education on Postoperative Outcomes in Total Knee Arthroplasty Patients
A study testing preoperative education in people with Knee Osteoarthritis and Pain, Postoperative, run by Hacettepe University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Pain, Postoperative, Kinesiophobia
- What is being tested?
- preoperative education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of noninflammatory arthritis
- Being the first to undergo Total knee arthroplasty surgery,
Who cannot join
- Lower extremity surgery in the last 1 year,
- Body mass index of 40 and above,
- Revision surgery
- Single compartment replacement
- Psychiatric illness
About this study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Pain, Postoperative, Kinesiophobia
- Being tested
- preoperative education
- Medical subject headings
- Osteoarthritis, Knee, Pain, Postoperative, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative educationOther
Education about knee anatomy, patophysiology, total knee arthroplasty surgery, pain neurophysiology, management of pain, the importance of exercise
| Study group | Role | What they receive |
|---|---|---|
| Education group | Experimental | Preoperative education Receives: Other: preoperative education |
| control | No intervention | Traditionally care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: five minutes
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.
Measured: Five minutes
Secondary outcomes (3)
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.
Measured: Five minutes
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.
Measured: One minute
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?"
Measured: Six minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Senem Demirdel, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178615
- Sponsor's protocol ID
- 2021-344
- Status last verified
- Jan 2022
- First submitted
- 1 Dec 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Preoperative Education on Postoperative Outcomes in Total Knee Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT05178615
- Acronym / sponsor ID
- 2021-344
- Conditions
- Knee Osteoarthritis, Pain, Postoperative, Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education group | Experimental | Other: preoperative educationPreoperative education |
| control | No intervention | –Traditionally care |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of noninflammatory arthritis
- Being the first to undergo Total knee arthroplasty surgery,
Key exclusion criteria (5 listed)
- Lower extremity surgery in the last 1 year,
- Body mass index of 40 and above,
- Revision surgery
- Single compartment replacement
- Psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative educationEducation about knee anatomy, patophysiology, total knee arthroplasty surgery, pain neurophysiology, management of pain, the importance of exercise | Other | Education group |
Primary outcome
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.
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.
3 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: Five minutes
Numerical Pain Rating Scale
Time frame: One minute
Patient satisfaction
Time frame: Six minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative education in people with Knee Osteoarthritis and Pain, Postoperative, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Beliefs Questionnaire (time frame: five minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.