PainKA-MobilityNCT05679947
Mobilization Protocol for Knee Arthroplasty Patients
A study testing Mobilization protocol in people with Pain and Anxiety, run by Gazi University at 2 sites in Turkey (Türkiye).
Trial summary
This randomized controlled study evaluates the effect of mobilization protocol applied to knee arthroplasty patients on anxiety level, pain, mobility and functional status. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Anxiety, Physical Function
- What is being tested?
- Mobilization protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2022to 28 Sep 2022
- 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
- Volunteering to participate in research
- Being 18 years or older
- Having unilateral elective knee arthroplasty surgery
- Having DA surgery for the first time
- It is the absence of an obstacle to communicating cognitively, emotionally and verbally.
Who cannot join
- Patients who initially agreed to participate in the study but wished to leave later were excluded from the study.
- In the event of a complication affecting the mobilization of the patient during the intraoperative and post-operative period, the patient is excluded from the study.
- He was excluded from the study due to the development of a cognitive, emotional and verbal barrier to communication after the surgery.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Turkey, Yozgat Bozok University, Yozgat Cıty Hospıtal
Yozgat
Yozgat Bozok University, Yozgat Cıty Hospıtal
Yozgat
About this study
Official title: The Effect of Mobilization Protocol Developed for Knee Arthroplasty Patients on Nursing Care-Sensitive Patient Outcomes
This randomized controlled study evaluates the effect of mobilization protocol applied to knee arthroplasty patients on anxiety level, pain, mobility and functional status.
Read the detailed description
In the study, 68 knee arthroplasty patients were randomly assigned to the study and control groups. The mobilization protocol was applied to the study group (34). The mobilization protocol starts on the day of the operation and is completed on the day of discharge. The patient is mobilized within the first 24 hours after surgery. Mobilization protocol includes six levels. Level 1: Repositioning should occur every two hours. Level 2: Range of motion (PROM) should occur at least three times a day. Level 3: The head of bed (HOB) >30 degrees. Duration goal: 5-15 minutes. HOB 65≥ degrees with patient sit in the bed. Duration goal: 5-15 minutes. Progress to level 4. Level 4: HOB 65≥ degrees with legs in dependent position (recliner chair). Duration goal: 5-15 minutes. Progress to level 5. Level 5: Stand/pivot/step to chair. Sitting in chair. Duration goal: 5-15 minutes. Progress to level 6. Level 6: Patient is able to ambulate at least three times a day. No intervention was applied to the control group. The primary outcome of the study is the effect of mobilization protocol on the state anxiety level, pain, mobility and physical function of knee arthroplasty patients. The results collected before the mobilization protocol, postoperative first day, second day, the discharged day and the 3rd week after discharge.
- Conditions
- Pain, Anxiety, Physical Function, Mobility, Arthroplasty
- Being tested
- Mobilization protocol
- Keywords
- knee arthroplasty, nursing, mobilization protocol, patient outcome, nurse sensitive outcomes, orthopaedic and trauma nursing
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization protocolOther
The mobilization protocol includes six levels. Protocol levels are applied from the day the patient is operated and ends on the day of discharge. The researcher explains the protocol levels to the patient before surgery.The patient is mobilized within the first 24 hours after surgery. Implement mobilization protocol three times during the day and more as tolerated. Mobilization protocol:Level 1: Repositioning should occur every two hours. Level 2: Range of motion (PROM) should occur at least three times a day. Level 3: The head of bed (HOB) >30 degrees. Duration goal: 5-15 minutes. HOB 65≥ degrees with patient sit in the bed. Duration goal: 5-15 minutes. Progress to level 4. Level 4: HOB 65≥ degrees with legs in dependent position (recliner chair). Duration goal: 5-15 minutes. Progress to level 5. Level 5: Stand/pivot/step to chair. Sitting in chair. Duration goal: 5-15 minutes. Progress to level 6. Level 6: Patient is able to ambulate at least three times a day.
| Study group | Role | What they receive |
|---|---|---|
| Mobilization Protocol | Experimental | The study group patients were mobilized according to the developed mobilization protocol.The protocol includes six levels. Protocol levels are applied from the day the patient is operated and ends on the discharged day. The researcher explains the protocol levels to the patient before surgery.The patient is mobilized within the first 24 h after surgery. Implement mobilization protocol 3 times during the day and more as tolerated. Mobilization protocol:Level 1: Repositioning should occur every 2 h. Level 2: ROM should occur at least 3 times a day. Level 3: The head of bed (HOB) >30 degrees. Duration goal: 5-15 min. HOB 65≥ degrees with patient sit in the bed. Duration goal: 5-15 min. Progress to level 4. Level 4: HOB 65≥ degrees with legs in dependent position (recliner chair). Duration goal: 5-15 min. Progress to level 5. Level 5: Stand/pivot/step to chair. Sitting in chair. Duration goal: 5-15 min. Progress to level 6. Level 6: Patient is able to ambulate at least 3 times a day. Receives: Other: 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 State Anxiety Inventory
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 State-Anxiety scale points at 3 weeks
Pain evaluated using the Vizüel Analog Scale (VAS)
The patient marks his or her own pain on a 10 cm ruler with painlessness on one end and the most severe pain on the other.
Measured: Change Pain scale points at 3 weeks
Physical function evaluated using knee injury and osteoarthritis outcome score-physical function short-form (KOOS-PS)
The KOOS-PS scale is used to evaluate the activities of daily living and physical function of people due to osteoarthritis and knee injuries. Patients reported the degree of difficulty they had experienced due to knee pain in the previous week: 1) getting out of bed, 2) wearing socks/pantyhose, 3) getting up from sitting position, 4) bending down, 5) bending/rotating the injured knee while on the injured knee, 6) knee sitting on top and 7) squatting. All items are scored on a 5-point Likert scale (none, mild, moderate, severe, extreme) between 0-4. Each question is scored between 0-4. The raw score is the sum of 7 items. The range score from 0-100 is obtained using a conversion table.
Measured: Change KOOS-PS scale points at 3 weeks
Patient Mobility Scale
The Patient Mobility Scale measures the pain and difficulty associated with four postoperative activities: (1) turning in bed, (2) sitting at the side of the bed, (3) standing, and (4) walking. by using separate 15-cm visual analog scales with word descriptors placed along the length of the scale.
Measured: Change Patient Mobility scale scores at 2 days
Observer Mobility Scale
The Observer Mobility Scale rates the degree of independence to dependence with numbers from 1 to 5 during performance of the four postoperative activities: (1) turning in bed, (2) sitting at the side of the bed, (3) standing, and (4) walking. A rating of 1 means the patient performs the activity independently without verbal prompting or assistance, and the rating of 5 means the patient is unable to perform the activity regardless of assistance or verbal prompting. The rank scores for turning, sitting, standing, and walking are summed, and a mean score is calculated for testing.
Measured: Change Observer Mobility scale scores at 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 May 2022
- Primary completion28 Sep 2022
- Study completion28 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, parallel group single blinded, randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Bozok University
- Responsible party
- Principal investigator, Sevil Güler, Gazi University
- Investigators
- Sevinç Meşe, MASTER, Principal investigator, Yozgat Bozok Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679947
- Sponsor's protocol ID
- E-77082166-604.01.02-140038
- Acronym
- KA-Mobility
- Status last verified
- Feb 2024
- First submitted
- 18 Dec 2022
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobilization Protocol Developed for Knee Arthroplasty Patients on Nursing Care-Sensitive Patient Outcomes
- ClinicalTrials.gov ID
- NCT05679947
- Acronym / sponsor ID
- KA-Mobility / E-77082166-604.01.02-140038
- Conditions
- Pain, Anxiety, Physical Function, Mobility, Arthroplasty
- Keywords
- knee arthroplasty, nursing, mobilization protocol, patient outcome, nurse sensitive outcomes, orthopaedic and trauma nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Bozok University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 11 Jan 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.
This randomized controlled study evaluates the effect of mobilization protocol applied to knee arthroplasty patients on anxiety level, pain, mobility and functional status.
Detailed description
In the study, 68 knee arthroplasty patients were randomly assigned to the study and control groups. The mobilization protocol was applied to the study group (34). The mobilization protocol starts on the day of the operation and is completed on the day of discharge. The patient is mobilized within the first 24 hours after surgery. Mobilization protocol includes six levels. Level 1: Repositioning should occur every two hours. Level 2: Range of motion (PROM) should occur at least three times a day. Level 3: The head of bed (HOB) >30 degrees. Duration goal: 5-15 minutes. HOB 65≥ degrees with patient sit in the bed. Duration goal: 5-15 minutes. Progress to level 4. Level 4: HOB 65≥ degrees with legs in dependent position (recliner chair). Duration goal: 5-15 minutes. Progress to level 5. Level 5: Stand/pivot/step to chair. Sitting in chair. Duration goal: 5-15 minutes. Progress to level 6. Level 6: Patient is able to ambulate at least three times a day. No intervention was applied to the control group. The primary outcome of the study is the effect of mobilization protocol on the state anxiety level, pain, mobility and physical function of knee arthroplasty patients. The results collected before the mobilization protocol, postoperative first day, second day, the discharged day and the 3rd week after discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, parallel group single blinded, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Mobilization Protocol | Experimental | Other: Mobilization protocolThe study group patients were mobilized according to the developed mobilization protocol.The protocol includes six levels. Protocol levels are applied from the day the patient is operated and ends on the discharged day. The researcher explains the protocol levels to the patient before surgery.The patient is mobilized within the first 24 h after surgery. Implement mobilization protocol 3 times during the day and more as tolerated. Mobilization protocol:Level 1: Repositioning should occur every 2 h. Level 2: ROM should occur at least 3 times a day. Level 3: The head of bed (HOB) >30 degrees. Duration goal: 5-15 min. HOB 65≥ degrees with patient sit in the bed. Duration goal: 5-15 min. Progress to level 4. Level 4: HOB 65≥ degrees with legs in dependent position (recliner chair). Duration goal: 5-15 min. Progress to level 5. Level 5: Stand/pivot/step to chair. Sitting in chair. Duration goal: 5-15 min. Progress to level 6. Level 6: Patient is able to ambulate at least 3 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 (5 listed)
- Volunteering to participate in research
- Being 18 years or older
- Having unilateral elective knee arthroplasty surgery
- Having DA surgery for the first time
- It is the absence of an obstacle to communicating cognitively, emotionally and verbally.
Key exclusion criteria (3 listed)
- Patients who initially agreed to participate in the study but wished to leave later were excluded from the study.
- In the event of a complication affecting the mobilization of the patient during the intraoperative and post-operative period, the patient is excluded from the study.
- He was excluded from the study due to the development of a cognitive, emotional and verbal barrier to communication after the surgery.
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 |
|---|---|---|
| Mobilization protocolThe mobilization protocol includes six levels. Protocol levels are applied from the day the patient is operated and ends on the day of discharge. The researcher explains the protocol levels to the patient before surgery.The patient is mobilized within the first 24 hours after surgery. Implement mobilization protocol three times during the day and more as tolerated. Mobilization protocol:Level 1: Repositioning should occur every two hours. Level 2: Range of motion (PROM) should occur at least three times a day. Level 3: The head of bed (HOB) >30 degrees. Duration goal: 5-15 minutes. HOB 65≥ degrees with patient sit in the bed. Duration goal: 5-15 minutes. Progress to level 4. Level 4: HOB 65≥ degrees with legs in dependent position (recliner chair). Duration goal: 5-15 minutes. Progress to level 5. Level 5: Stand/pivot/step to chair. Sitting in chair. Duration goal: 5-15 minutes. Progress to level 6. Level 6: Patient is able to ambulate at least three times a day. | Other | Mobilization Protocol |
Primary outcome
Anxiety evaluated using the State Anxiety Inventory
Time frame: Change State-Anxiety scale points at 3 weeks
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
Pain evaluated using the Vizüel Analog Scale (VAS)
Time frame: Change Pain scale points at 3 weeks
The patient marks his or her own pain on a 10 cm ruler with painlessness on one end and the most severe pain on the other.
Physical function evaluated using knee injury and osteoarthritis outcome score-physical function short-form (KOOS-PS)
Time frame: Change KOOS-PS scale points at 3 weeks
The KOOS-PS scale is used to evaluate the activities of daily living and physical function of people due to osteoarthritis and knee injuries. Patients reported the degree of difficulty they had experienced due to knee pain in the previous week: 1) getting out of bed, 2) wearing socks/pantyhose, 3) getting up from sitting position, 4) bending down, 5) bending/rotating the injured knee while on the injured knee, 6) knee sitting on top and 7) squatting. All items are scored on a 5-point Likert scale (none, mild, moderate, severe, extreme) between 0-4. Each question is scored between 0-4. The raw score is the sum of 7 items. The range score from 0-100 is obtained using a conversion table.
Patient Mobility Scale
Time frame: Change Patient Mobility scale scores at 2 days
The Patient Mobility Scale measures the pain and difficulty associated with four postoperative activities: (1) turning in bed, (2) sitting at the side of the bed, (3) standing, and (4) walking. by using separate 15-cm visual analog scales with word descriptors placed along the length of the scale.
Observer Mobility Scale
Time frame: Change Observer Mobility scale scores at 2 days
The Observer Mobility Scale rates the degree of independence to dependence with numbers from 1 to 5 during performance of the four postoperative activities: (1) turning in bed, (2) sitting at the side of the bed, (3) standing, and (4) walking. A rating of 1 means the patient performs the activity independently without verbal prompting or assistance, and the rating of 5 means the patient is unable to perform the activity regardless of assistance or verbal prompting. The rank scores for turning, sitting, standing, and walking are summed, and a mean score is calculated for testing.
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 26 Feb 2024.
- 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.
Sevinç Meşe, MASTER principal investigator
Yozgat Bozok Universty
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization protocol in people with Pain and Anxiety, run by Gazi 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 5 inclusion and 3 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 26 Feb 2024. 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?
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 State Anxiety Inventory (time frame: Change State-Anxiety scale points at 3 weeks). The study lists 5 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 26 Feb 2024.