Knee ArthroplastyNCT06268899
First Mobilization Protocol for Total Knee Arthroplasty Patients
A study testing First mobilization protocol in people with Knee Arthroplasty, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This single blinded randomized controlled study evaluates the effect of developed First Mobilization Protocol applied to knee arthroplasty patients on state anxiety, kinesiophobia, initial mobilization related symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- First mobilization protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2023to 30 Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older,
- First time knee arthroplasty surgery,
- Have not received a diagnosis that will prevent communication,
- No physical disability,
- Mobilized during the implementation process of the research,
- Bilateral arthroplasty surgery is not performed,
Who cannot join
- Revision surgery performed,
- Patients who have undergone total hip or knee arthroplasty before,
- Inability to perform or delay mobilization due to complication(s) developed in the postoperative period,
- The patient cannot be mobilized on the first postoperative day (in the first 48 hours),
- Desire to leave the research voluntarily.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Health Research and Application Center
Ankara, 06560
About this study
Official title: Evaluation of the Effectiveness of the Fırst Mobilization Protocol Developed for Knee Arthroplasty Patients
This single blinded randomized controlled study evaluates the effect of developed First Mobilization Protocol applied to knee arthroplasty patients on state anxiety, kinesiophobia, initial mobilization related symptoms.
Read the detailed description
Ensuring the mobilization of patients in the postoperative period, preventing complications resulting from inactivity, maintaining homeostatic balance and accelerating recovery are among the important goals of nursing care. For this reason, it is necessary to gradually increase the patients in line with the evidence-based data and the importance of mobilization should be emphasized. In this study, it was aimed to develop the first mobilization protocol for patients undergoing total knee arthroplasty and to evaluate the effectiveness of the developed protocol on patients' state anxiety, kinesiophobia, initial mobilization related symptoms.
The research is planned to be conducted in the Orthopedics and Traumatology Clinic of a university hospital in Turkey. The protocol of the study will be completed with78 patients who meet the sampling criteria (39 interventions, 39 controls), although it was designed as a single-center, single-blind randomized controlled and prospective study. Patient Information Form, State-Trait Anxiety Inventory, Tampa Kinesiophobia Scale and Initial Mobilization-Related Symptoms Evaluation Form will be used to collect the data of the study. Study; It is a single-center and single-blind randomized controlled experimental study protocol.
The data obtained within the scope of the study will be explained after being collected and analyzed. The effectiveness of the first mobilization protocol developed for tolal knee arthroplasty patients will be evaluated.
- Conditions
- Knee Arthroplasty
- Being tested
- First mobilization protocol
- Keywords
- Total Knee Arthroplasty, Nursing, Mobilization, Ambulation, First Mobilization Protocol, Orthopaedic and trauma nursing, Anxiety, Kinesiophobia, Mobilization related symptoms
- Medical subject headings
- Anxiety Disorders, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First mobilization protocolOther
The protocol phases start one day before the patient's surgery and end on the first day of mobilization after surgery. The investigator explains the protocol steps to the patient before surgery and the patient is mobilized within the first 24 hours after surgery. Perform the protocol 4 times a day and more as tolerated. Mobilization protocol: Level 1: Patient is informed about mobilization and readiness is reinforced. Level 2: Passive and active ROM movements in bed should be performed at least 3 times a day. Level 3: Head of bed >60 degrees when the patient is sitting in bed. Duration target: 10-15 minutes. Level 4: Patient is seated on the edge of the bed. Duration target: 10-15 minutes. Level 5: The patient is helped to stand up. Level 6: First mobilization is achieved by allowing the patient to take 10-15 steps. The patient can mobilize at least 4 times a day.
| Study group | Role | What they receive |
|---|---|---|
| First mobilization protocol | Experimental | The protocol phases start one day before the patient's surgery and end on the first day of mobilization after surgery. The investigator explains the protocol steps to the patient before surgery and the patient is mobilized within the first 24 hours after surgery. Perform the protocol 4 times a day and more as tolerated. Mobilization protocol: Level 1: Patient is informed about mobilization and readiness is reinforced. Level 2: Passive and active ROM movements in bed should be performed at least 3 times a day. Level 3: Head of bed >60 degrees when the patient is sitting in bed. Duration target: 10-15 minutes. Level 4: Patient is seated on the edge of the bed. Duration target: 10-15 minutes. Level 5: The patient is helped to stand up. Level 6: First mobilization is achieved by allowing the patient to take 10-15 steps. The patient can mobilize at least 4 times a day. Receives: Other: First mobilization protocol |
| Control | No intervention | No intervention was made to the control group, only data were collected at the same time as the study group.The patients in the control group was mobilized by the researchers according to the routine clinical mobilization practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety evaluated using the Trait Anxiety Inventory (Trait Anxiety Inventory, TAI)
The "Trait Anxiety Inventory (STAI FORM TX-2, SDS)" allows the individual to express how he or she generally feels. the emotions and behaviors expressed in the scale items are according to their degrees; It is marked as (1) Almost Never, (2) Sometimes, (3) Often, and (4) Almost Always. 0-19 points from the scale mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.
Measured: Change Trait Anxiety scale points on one day
Kinesiophobia evaluated using the Tampa Kinesiophobia Scale
The Tampa Kinesiophobia Scale (TKS) was used to evaluate the patients' fear of moving. The scale consists of 17 items and has a Likert type feature. Scale items are used in the form of 4-point Likert scoring (1=Strongly disagree, 2=Disagree, 3=Agree, 4=Completely agree) and the total score ranges from 17-68. A high score from the scale indicates a high fear of movement. It is recommended to use the total score obtained from the scale in studies. It was stated that the test-retest reliability was 0.81.
Measured: Change Kinesiophobia scale points on two days
Anxiety evaluated using the State Anxiety Inventory (State Anxiety Inventory, SAI)
The State-Anxiety scale consists of twenty statements that evaluate how respondents' feel about anxiety "right now, at this moment" through four scales: one (not at all), two (somewhat), three (moderately so), and four (very much so). A rating of four indicates the presence of a high level anxiety and one indicates the absence of a high level anxiety. The anxiety level was found by calculation of scores, The range of scores is from 20-80, the higher the score indicating greater anxiety.
Measured: Change Trait and State-Anxiety scale points on one day
Symptoms evaluated using the Numerical Rating Scale for Symptoms Related to First Mobilization
Patients' symptoms related to the first mobilization (pain, dizziness, nausea, blackout, anxiety, stress, fear of damaging the surgery site, fear of falling, inability to walk/movement, walking distance on the first day, walking distance at the end of the first day, total walking at the end of the first day) distance, total mobilization per day, orthostatic intolerance, orthostatic hypotension) will be scored using a Numerical Comparison Scale from 0-10. This form will be used before and after mobilization on the day of the first mobilization of the patients.
Measured: Change symptoms points on one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start8 Jan 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
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 Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study protocol describes the design of a single-center, single-blind, statistician-blind randomized controlled trial to be conducted in the Orthopedics and Traumatology Clinic of a provincial university hospital in Turkey.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University
- Responsible party
- Principal investigator, Sevil Güler, Gazi University
- Investigators
- Ayse Gul ATAY DOYGACI, Master, Principal investigator, Baskent Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268899
- Sponsor's protocol ID
- E-77082166-302.08.01-285977
- Status last verified
- Dec 2024
- First submitted
- 9 Feb 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atay Doygaci AG, Guler S, Esen E. Effectiveness of a First Mobilization Protocol in Patients Undergoing Knee Arthroplasty: A Randomized Contolled Trial. J Perianesth Nurs. 2026 Jul 15:S1089-9472(26)00143-7. doi: 10.1016/j.jopan.2026.05.002. Online ahead of print.
PubMed 42455081
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Fırst Mobilization Protocol Developed for Knee Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT06268899
- Acronym / sponsor ID
- E-77082166-302.08.01-285977
- Conditions
- Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Nursing, Mobilization, Ambulation, First Mobilization Protocol, Orthopaedic and trauma nursing, Anxiety, Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Baskent University
- Study start
- 8 Jan 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 20 Feb 2024 (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.
This single blinded randomized controlled study evaluates the effect of developed First Mobilization Protocol applied to knee arthroplasty patients on state anxiety, kinesiophobia, initial mobilization related symptoms.
Detailed description
Ensuring the mobilization of patients in the postoperative period, preventing complications resulting from inactivity, maintaining homeostatic balance and accelerating recovery are among the important goals of nursing care. For this reason, it is necessary to gradually increase the patients in line with the evidence-based data and the importance of mobilization should be emphasized. In this study, it was aimed to develop the first mobilization protocol for patients undergoing total knee arthroplasty and to evaluate the effectiveness of the developed protocol on patients' state anxiety, kinesiophobia, initial mobilization related symptoms.
The research is planned to be conducted in the Orthopedics and Traumatology Clinic of a university hospital in Turkey. The protocol of the study will be completed with78 patients who meet the sampling criteria (39 interventions, 39 controls), although it was designed as a single-center, single-blind randomized controlled and prospective study. Patient Information Form, State-Trait Anxiety Inventory, Tampa Kinesiophobia Scale and Initial Mobilization-Related Symptoms Evaluation Form will be used to collect the data of the study. Study; It is a single-center and single-blind randomized controlled experimental study protocol.
The data obtained within the scope of the study will be explained after being collected and analyzed. The effectiveness of the first mobilization protocol developed for tolal knee arthroplasty patients will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study protocol describes the design of a single-center, single-blind, statistician-blind randomized controlled trial to be conducted in the Orthopedics and Traumatology Clinic of a provincial university hospital in Turkey.
| Arm | Type | Receives |
|---|---|---|
| First mobilization protocol | Experimental | Other: First mobilization protocolThe protocol phases start one day before the patient's surgery and end on the first day of mobilization after surgery. The investigator explains the protocol steps to the patient before surgery and the patient is mobilized within the first 24 hours after surgery. Perform the protocol 4 times a day and more as tolerated. Mobilization protocol: Level 1: Patient is informed about mobilization and readiness is reinforced. Level 2: Passive and active ROM movements in bed should be performed at least 3 times a day. Level 3: Head of bed >60 degrees when the patient is sitting in bed. Duration target: 10-15 minutes. Level 4: Patient is seated on the edge of the bed. Duration target: 10-15 minutes. Level 5: The patient is helped to stand up. Level 6: First mobilization is achieved by allowing the patient to take 10-15 steps. The patient can mobilize at least 4 times a day. |
| Control | No intervention | –No intervention was made to the control group, only data were collected at the same time as the study group.The patients in the control group was mobilized by the researchers according to the routine clinical mobilization practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years and older,
- First time knee arthroplasty surgery,
- Have not received a diagnosis that will prevent communication,
- No physical disability,
- Mobilized during the implementation process of the research,
Key exclusion criteria (5 listed)
- Revision surgery performed,
- Patients who have undergone total hip or knee arthroplasty before,
- Inability to perform or delay mobilization due to complication(s) developed in the postoperative period,
- The patient cannot be mobilized on the first postoperative day (in the first 48 hours),
- Desire to leave the research voluntarily.
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 |
|---|---|---|
| First mobilization protocolThe protocol phases start one day before the patient's surgery and end on the first day of mobilization after surgery. The investigator explains the protocol steps to the patient before surgery and the patient is mobilized within the first 24 hours after surgery. Perform the protocol 4 times a day and more as tolerated. Mobilization protocol: Level 1: Patient is informed about mobilization and readiness is reinforced. Level 2: Passive and active ROM movements in bed should be performed at least 3 times a day. Level 3: Head of bed >60 degrees when the patient is sitting in bed. Duration target: 10-15 minutes. Level 4: Patient is seated on the edge of the bed. Duration target: 10-15 minutes. Level 5: The patient is helped to stand up. Level 6: First mobilization is achieved by allowing the patient to take 10-15 steps. The patient can mobilize at least 4 times a day. | Other | First mobilization protocol |
Primary outcome
Anxiety evaluated using the Trait Anxiety Inventory (Trait Anxiety Inventory, TAI)
Time frame: Change Trait Anxiety scale points on one day
The "Trait Anxiety Inventory (STAI FORM TX-2, SDS)" allows the individual to express how he or she generally feels. the emotions and behaviors expressed in the scale items are according to their degrees; It is marked as (1) Almost Never, (2) Sometimes, (3) Often, and (4) Almost Always. 0-19 points from the scale mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.
Kinesiophobia evaluated using the Tampa Kinesiophobia Scale
Time frame: Change Kinesiophobia scale points on two days
The Tampa Kinesiophobia Scale (TKS) was used to evaluate the patients' fear of moving. The scale consists of 17 items and has a Likert type feature. Scale items are used in the form of 4-point Likert scoring (1=Strongly disagree, 2=Disagree, 3=Agree, 4=Completely agree) and the total score ranges from 17-68. A high score from the scale indicates a high fear of movement. It is recommended to use the total score obtained from the scale in studies. It was stated that the test-retest reliability was 0.81.
Anxiety evaluated using the State Anxiety Inventory (State Anxiety Inventory, SAI)
Time frame: Change Trait and State-Anxiety scale points on one day
The State-Anxiety scale consists of twenty statements that evaluate how respondents' feel about anxiety "right now, at this moment" through four scales: one (not at all), two (somewhat), three (moderately so), and four (very much so). A rating of four indicates the presence of a high level anxiety and one indicates the absence of a high level anxiety. The anxiety level was found by calculation of scores, The range of scores is from 20-80, the higher the score indicating greater anxiety.
Symptoms evaluated using the Numerical Rating Scale for Symptoms Related to First Mobilization
Time frame: Change symptoms points on one day
Patients' symptoms related to the first mobilization (pain, dizziness, nausea, blackout, anxiety, stress, fear of damaging the surgery site, fear of falling, inability to walk/movement, walking distance on the first day, walking distance at the end of the first day, total walking at the end of the first day) distance, total mobilization per day, orthostatic intolerance, orthostatic hypotension) will be scored using a Numerical Comparison Scale from 0-10. This form will be used before and after mobilization on the day of the first mobilization of the patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 42455081Atay Doygaci AG, Guler S, Esen E. Effectiveness of a First Mobilization Protocol in Patients Undergoing Knee Arthroplasty: A Randomized Contolled Trial. J Perianesth Nurs. 2026 Jul 15:S1089-9472(26)00143-7. doi: 10.1016/j.jopan.2026.05.002. Online ahead of print.
- 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.
Ayse Gul ATAY DOYGACI, Master principal investigator
Baskent Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First mobilization protocol in people with Knee Arthroplasty, run by Gazi University at 1 site 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 6 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: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anxiety evaluated using the Trait Anxiety Inventory (Trait Anxiety Inventory, TAI) (time frame: Change Trait Anxiety scale points on one day). The study lists 4 primary outcomes in all. 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 NCT06268899, 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 5 Dec 2024.