- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05950217
Kinesiophobia in Patients Undergoing Total Knee Replacement Surgery
July 17, 2023 updated by: Bahar CANDAS ALTINBAS, Karadeniz Technical University
The Effect of Preoperative Education on Kinesiophobia in Patients Undergoing Total Knee Replacement Surgery: A Randomized Controlled Study
Providing information to the patient before surgery has important effects on the patient's self-care skills regarding the treatment and care process, reducing stress and reducing fears in the postoperative period.
The primary aim of this study was to examine the effect of preoperative education on kinesiophobia in patients undergoing total knee replacement surgery.
In addition, preoperative anxiety levels, time of first postoperative mobilization, number of steps in the first 24 hours after mobilization and pain levels of the patients will be evaluated as secondary outcomes.
Study Overview
Detailed Description
Kinesiophobia is known as the minimization of activities or avoidance of movement due to the fear that the pain caused by movement will negatively affect the person's life and the problem will occur again.
It was first defined by Miller, Kopri and Todd in 1990 at the American Pain Society meeting as excessive and unreasonable anxiety against physical movement and pain in the person, which occurs due to the person feeling vulnerable as a result of a painful injury or re-injury.
Kinesiophobia is one of the factors that contribute to the chronicization of pain in individuals after surgery; it can lead to negative patient behaviors on the disease in the surgical process.
In addition, kinesiophobia can lead to movement limitation and movement limitation can lead to pain.
Since this vicious cycle may result in more pain and disability, the importance of the issue is increasing.
It has also been shown that patients with high levels of kinesiophobia experience more pain and have a lower quality of life.
This research project aims to provide an original approach in a field where studies on preventing or minimizing the effects of kinesiophobia on the surgical process and postoperative recovery process are limited.
It is expected that nurses' interventions for kinesiophobia during the operation process will have positive effects on treatment and care.
In this study, visual material-supported patient education will be provided to reduce the level of kinesiophobia associated with total knee replacement surgery.
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bahar Candas Altinbas, PhD
- Phone Number: +90 545 9125343
- Email: baharcandas88@gmail.com
Study Contact Backup
- Name: Nurdan Reis
- Phone Number: +90 546 7832632
- Email: nurdangungoreis@gmail.com
Study Locations
-
-
-
Trabzon, Turkey, 61800
- Bahar Candas Altinbas
-
Contact:
- Bahar Candas Altinbas, PhD
- Phone Number: +90 545 9125343
- Email: baharcandas88@gmail.com
-
Trabzon, Turkey, 61800
- Nurdan Reis
-
Contact:
- Nurdan Reis
- Phone Number: +90 6547832632
- Email: nurdangungoreis@gmail.com
-
-
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
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 65 years of age or older
- Planned surgery
- Speaking and understanding Turkish
- Being admitted to the hospital at least one day before the surgery
Exclusion Criteria:
- Visual, hearing and speech disabilities,
- Being mentally disabled,
- Having a psychiatric disorder or being in the process of treatment
- Having had knee replacement surgery before
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
The control group will take rutin patient care.
|
|
Experimental: Experimental Group
The experimental group patients will be educated by the nurse in the preoperative period with the support of visual education material
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Nurse-led patient education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kinesiophobia
Time Frame: 2 days
|
Self reported kinesiophobia intensity after surgical process that includes one day after surgery.
TAMPA Kinesiophobia Scale (TSK) will be used to evaluate the kinesiophobia.
The TSK consists of 17 items that are rated on a 4-point Likert scale, ranging from "Strongly Disagree" to "Strongly Agree."
It is scored by assigning a numerical value to each response.
Individual item scores range from 1-4, with the negatively worded items (4,8,12,16) having a reverse scoring (4-1).
The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety level
Time Frame: 2 days
|
Self reported anxiety intensity before surgical process that includes on the day of surgery.
State-Trait Anxiety Inventory will be used to evaluate the anxiety.
The higher the score is the more anxiety.
|
2 days
|
Pain level
Time Frame: 1 day
|
It means that what is the severity of the pain that the patients had in 24 hours after surgery.
It evaluated with Visual Analog Scale.
The most common style used in pain measurement uses a horizontal line measuring exactly 10 cm.
The patient is asked to make a mark on this line (from 0 to 10), then the line is measured and recorded in millimeters or centimeters.
The higher the score is the more severe the pain.
The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
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1 day
|
First postoperative mobilization time
Time Frame: 1 day
|
How many hours after surgery did the patients walk for the first time?
This metric will be recorded as day using a questionnaire.
The minimum, maximum, median, 25th, and 75th quartiles were calculated for each group and compared.
The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
|
1 day
|
Number of steps in the first 24 hours after mobilization
Time Frame: 1 day
|
How many steps did the patients take in 24 hours after surgery?
This parameter will be evaluated with a pedometer bracelet to be worn on the arm of the patients.
The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bahar Candas Altinbas, PhD, Karadeniz Technical University
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 (Estimated)
August 1, 2023
Primary Completion (Estimated)
December 29, 2023
Study Completion (Estimated)
May 29, 2024
Study Registration Dates
First Submitted
July 10, 2023
First Submitted That Met QC Criteria
July 10, 2023
First Posted (Actual)
July 18, 2023
Study Record Updates
Last Update Posted (Actual)
July 19, 2023
Last Update Submitted That Met QC Criteria
July 17, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nurse_Kinesiophobia02
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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