KinesiophobiaNCT05950217
Kinesiophobia in Patients Undergoing Total Knee Replacement Surgery
A study testing Education in people with Kinesiophobia, run by Karadeniz Technical University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kinesiophobia
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 29 May 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years of age or older
- Planned surgery
- Speaking and understanding Turkish
- Being admitted to the hospital at least one day before the surgery
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bahar Candas Altinbas
Trabzon, 61800
Bahar Candas Altinbas, PhD, +90 545 9125343, baharcandas88@gmail.com
Nurdan Reis
Trabzon, 61800
Nurdan Reis, +90 6547832632, nurdangungoreis@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Kinesiophobia
- Being tested
- Education
- Keywords
- Kinesiophobia, Knee replacement, Nursing education, Preoperative care
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Nurse-led patient education
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group patients will be educated by the nurse in the preoperative period with the support of visual education material Receives: Other: Education |
| Control Group | No intervention | The control group will take rutin patient care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophobia
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.
Measured: 2 days
Secondary outcomes (4)
Anxiety level
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.
Measured: 2 days
Pain level
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.
Measured: 1 day
First postoperative mobilization time
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.
Measured: 1 day
Number of steps in the first 24 hours after mobilization
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion29 Dec 2023 (estimated)
- Study completion29 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KinesiophobiaStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar CANDAS ALTINBAS, Karadeniz Technical University
- Investigators
- Bahar Candas Altinbas, PhD, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950217
- Sponsor's protocol ID
- Nurse_Kinesiophobia02
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reis N, Candas Altinbas B. Nurse-led preoperative education on kinesiophobia in older adult patients undergoing total knee arthroplasty: A randomized controlled trial. Geriatr Nurs. 2026 Jul;71:104124. doi: 10.1016/j.gerinurse.2026.104124. Epub 2026 Jun 8.
PubMed 42258910
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Education on Kinesiophobia in Patients Undergoing Total Knee Replacement Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05950217
- Acronym / sponsor ID
- Nurse_Kinesiophobia02
- Conditions
- Kinesiophobia
- Keywords
- Kinesiophobia, Knee replacement, Nursing education, Preoperative care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 29 Dec 2023 (estimated)
- Study completion
- 29 May 2024 (estimated)
- First posted
- 18 Jul 2023 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: EducationThe experimental group patients will be educated by the nurse in the preoperative period with the support of visual education material |
| Control Group | No intervention | –The control group will take rutin patient care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 65 years of age or older
- Planned surgery
- Speaking and understanding Turkish
- Being admitted to the hospital at least one day before the surgery
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| EducationNurse-led patient education | Other | Experimental Group |
Primary outcome
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.
4 secondary outcomes
Anxiety level
Time frame: 2 days
Pain level
Time frame: 1 day
First postoperative mobilization time
Time frame: 1 day
Number of steps in the first 24 hours after mobilization
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Derived from this study: PubMed 42258910Reis N, Candas Altinbas B. Nurse-led preoperative education on kinesiophobia in older adult patients undergoing total knee arthroplasty: A randomized controlled trial. Geriatr Nurs. 2026 Jul;71:104124. doi: 10.1016/j.gerinurse.2026.104124. Epub 2026 Jun 8.
- Individual participant dataSharing planned: No
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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.
Bahar Candas Altinbas, PhD principal investigator
Karadeniz Technical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Kinesiophobia, run by Karadeniz Technical University at 2 sites in Turkey (Türkiye).
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 4 inclusion and 4 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 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Bahar Candas Altinbas, PhD (+90 545 9125343, baharcandas88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinesiophobia (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05950217, which also lists 1 linked publication.
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 19 Jul 2023.