Early AmbulationNCT05587985
The Effect of Early Mobilization on Pain and Mobility Levels
An observational study of Early Ambulation, run by Bartın Unıversity.
Trial summary
Objective: This study will be conducted to determine the effect of early mobilization on pain and mobility levels in patients who underwent total knee prothesis. Method: This study, which was designed as a randomized controlled experimental type, will be conducted with a total of 68 patients, 34 of whom were in the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early Ambulation
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 1 Oct 2023
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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
Study population: The patients who were hospitalized in the orthopedics and traumatology service of Bartın State Hospital and who had undergone total knee replacement surgery constitute the scope of this study.
Who may be able to join
- Having a total knee replacement surgery
- Volunteering
- Being over 18 years old
Who cannot join
- Not volunteering
- Patients for whom early mobilization is contraindicated (without physician approval)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Early Mobilization on Pain and Mobility Levels in Patients Undergoing Total Knee Prothesis
Objective: This study will be conducted to determine the effect of early mobilization on pain and mobility levels in patients who underwent total knee prothesis.
Method: This study, which was designed as a randomized controlled experimental type, will be conducted with a total of 68 patients, 34 of whom were in the control group and 34 in the experimental group, who underwent total knee prothesis surgery in the orthopedics and traumatology service at Bartın State Hospital between September 2022 and June 2023. Research data will be collected with Participant Information Form, Brief Pain Inventory, Patient Mobility Scale and Observer Mobility Scale. During the data collection process, the pain level of the experimental group will be evaluated at the 8th hour after the operation, then the level of mobility will be evaluated by providing mobilization. The control group will only be evaluated for pain at the 8th hour after surgery, and they will not be mobilized. At the 20th hour after the surgery, pain assessment of both groups will be made, and then their mobility will be evaluated, and their mobility levels will be evaluated. SPSS 22.0 program will be used in the evaluation of the data. Whether the data is normally distributed or not will be tested by Shapiro-wilk analysis. According to the result of this, parametric and nonparametric methods will be used.
Read the detailed description
Introduction: Pain development is an expected situation in individuals who have undergone total knee replacement surgery. Again, in these patients, the tendency to stay still increases due to the surgery and pain. International guidelines and other studies indicate that early mobilization of patients after surgical interventions is effective in preventing complications that can be caused by inactivity and reducing the severity of pain in patients. Early mobilization gains importance in order to accelerate the recovery process of patients after total knee replacement surgery and to prevent problems such as muscle mass loss and muscle weakness that may arise from long-term bed rest.
Objective: This study will be conducted to determine the effect of early mobilization on pain and mobility levels in patients who underwent total knee replacement.
Method: This study, which was designed as a randomized controlled experimental type, will be conducted with a total of 68 patients, 34 of whom were in the control group and 34 in the experimental group, who underwent total knee replacement surgery in the orthopedics and traumatology service at Bartın State Hospital between September 2022 and June 2023. Research data will be collected with Participant Information Form, Brief Pain Inventory, Patient Mobility Scale and Observer Mobility Scale. The patients in the experimental group will not be mobilized until the 8th hour, and their first mobilization will be carried out at the 8th hour. The pain levels of the patients in the experimental group at the 8th hour will be evaluated with the Brief Pain Inventory and their mobilization will be ensured. Mobility levels after mobilization will be recorded by evaluating with the Patient Mobility Scale and by the research nurse who mobilized the patient with the Observer Mobility Scale. Patients in the control group will not be mobilized until the 20th hour after surgery. Patients will be evaluated only for pain at the 8th hour after surgery. The first mobilizations will be made at the 20th hour after the surgery, and their mobility levels will be evaluated with the Observer Mobility Scale and the Patient Mobility Scale by both the patient and the researching nurse who mobilized them. Pain assessment will be performed in both groups at the 20th hour and then their mobility will be evaluated. SPSS 22.0 program will be used in the evaluation of the data. Whether the data is normally distributed or not will be tested by Shapiro-wilk analysis. According to the result of this, parametric and nonparametric methods will be used.
Conclusion: If the research is carried out successfully, the differences caused by early mobilization in the pain levels and mobility levels of the patients will be revealed. The fact that early mobilization causes a decrease in the level of pain, as stated in the literature, will enable patients to be mobilized earlier. Again, if early mobilization has a positive effect on the mobility level of the patients, the patients will be able to be mobilized early for this purpose.
- Conditions
- Early Ambulation
- Keywords
- Total knee replacement, early mobilization, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | * After randomization, 34 patients will be included in the experimental group. This group is the group to be mobilized early after surgery. * During the data collection process, the pain level of the experimental group will be evaluated at the 8th hour after the operation, then the level of mobility will be evaluated by providing mobilization. * At the 20th hour after the surgery, pain assessment of both groups will be made, and then their mobility will be evaluated, and their mobility levels will be evaluated. | |
| Control Group | * After randomization, 34 patients will be included in the control group. This group is the group that did not undergo early mobilization. * The control group will only be evaluated for pain at the 8th hour after surgery, and they will not be mobilized. * At the 20th hour after the surgery, pain assessment of both groups will be made, and then their mobility will be evaluated, and their mobility levels will be evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain status
At the 8th hour, the pain status of the patients in the control and experimental groups will be evaluated with the Brief Pain Inventory.
Brief Pain Inventory; It is a form consisting of 9 questions in total. The first question compares the individual's pain with past pain experiences, the second question includes an image where the individual will mark the pain area. The next four questions serve to measure pain intensity with a numerical pain scale. Numerical pain scale is evaluated in the range of 0-10. "0" means no pain, "10" means unbearable pain. The last question evaluates the level of influence of factors such as mobility, emotional state, breathing, coughing exercise, interpersonal relations, walking, working and enjoying life, sleep, due to pain in the last 24 hours, with a value in the range of 0-10. "0" means not affected at all, "10" means completely affected. The higher the score, the higher the pain intensity.
Measured: 8 hours
level of mobility
At the 8th hour, the mobility levels of the patients in the control and experimental groups will be evaluated with the Observer Mobility Scale.
Observer Mobility Scale: While performing four activities after surgery, dependency/independence status and degree are evaluated between 1 and 5. 1 indicates that the patient cannot perform the activity independently without the need for verbal stimulation or physical assistance, and 5 indicates that the patient cannot perform the activity even with verbal stimulation or physical assistance. As a result, the Global Patient Mobility score is obtained by summing the scores of all activities. The minimum and maximum score that can be obtained from the scale is between 1-5, and the total score is between 4-20. An increase in the score indicates that the patient's mobility skills are insufficient, and a decrease in the score indicates that the patient's mobility is sufficient after the surgery.
Measured: 8 hours
pain status
At the 20th hour, the pain status of the patients in the control and experimental groups will be evaluated with the Brief Pain Inventory.
Brief Pain Inventory; It is a form consisting of 9 questions in total. The first question compares the individual's pain with past pain experiences, the second question includes an image where the individual will mark the pain area. The next four questions serve to measure pain intensity with a numerical pain scale. Numerical pain scale is evaluated in the range of 0-10. "0" means no pain, "10" means unbearable pain. The last question evaluates the level of influence of factors such as mobility, emotional state, breathing, coughing exercise, interpersonal relations, walking, working and enjoying life, sleep, due to pain in the last 24 hours, with a value in the range of 0-10. "0" means not affected at all, "10" means completely affected. The higher the score, the higher the pain intensity.
Measured: 20 hours
level of mobility
At the 20th hour, the mobility levels of the patients in the control and experimental groups will be evaluated with the Patient Mobility Scale.
Patient Mobility Scale: It is applied to evaluate the level of pain and difficulty in performing the four activities: turning from one side to the other in the bed, sitting by the bed, standing up by the bed and walking in the patient's room after the surgery. The numerical value of the degree of pain and difficulty is determined by measuring the distance between the mark on the scale and zero with a calibrated ruler. There are two subgroup questions for each activity. The questions are answered as 1 to 5 to determine the level and severity of pain perception, 1 was no pain, 5 was the worst pain I could imagine, and the difficulty levels of the activities were between 1 and 5, 1 was very easy, 5 was very difficult. As a result, the Global Patient Mobility score is obtained by summing the scores of all activities.
Measured: 20 hours
Secondary outcomes (2)
pain levels
The correlation between the sociodemographic and clinical characteristics of the patients (patient's age, gender, educational status, height, weight, BMI, analgesic drug used, anesthesia method applied during the operation and duration of the operation) in the experimental and control groups and their pain status will be evaluated with the Brief Pain Inventory at the 8th and 20th hours.
Brief Pain Inventory; It is a form consisting of 9 questions in total. The first question compares the individual's pain with past pain experiences, the second question includes an image where the individual will mark the pain area. The next four questions serve to measure pain intensity with a numerical pain scale. Numerical pain scale is evaluated in the range of 0-10. "0" means no pain, "10" means unbearable pain. The last question evaluates the level of influence of factors such as mobility, emotional state, breathing, coughing exercise, interpersonal relations, walking, working and enjoying life,
Measured: 0-20 hours
mobility levels
The correlation between sociodemographic and clinical characteristics of the patients (patient's age, gender, educational status, height, weight, BMI, analgesic drug used, anesthesia method applied during the operation and duration of the operation) in the experimental and control groups and their the Observer Mobility Scale and the Patient Mobility Scale will be evaluated with at the 8th and 20th hours.
Patient Mobility Scale: It is applied to evaluate the level of pain and difficulty in performing the four activities: turning from one side to the other in the bed, sitting by the bed, standing up by the bed and walking in the patient's room after the surgery. The numerical value of the degree of pain and difficulty is determined by measuring the distance between the mark on the scale and zero with a calibrated ruler. There are two subgroup questions for each activity. The questions are answered as 1 to 5 to determine the level and severity of pain perception.
Measured: 0-20 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early AmbulationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mediha Didem Kocoglu Agca, Bartın Unıversity
- Investigators
- Mediha Didem KOCOGLU, Study chair, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587985
- Sponsor's protocol ID
- 2022-SBB-0345
- Status last verified
- Oct 2022
- First submitted
- 6 Oct 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Mobilization on Pain and Mobility Levels in Patients Undergoing Total Knee Prothesis
- ClinicalTrials.gov ID
- NCT05587985
- Acronym / sponsor ID
- 2022-SBB-0345
- Conditions
- Early Ambulation
- Keywords
- Total knee replacement, early mobilization, pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 20 Oct 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.
Objective: This study will be conducted to determine the effect of early mobilization on pain and mobility levels in patients who underwent total knee prothesis.
Method: This study, which was designed as a randomized controlled experimental type, will be conducted with a total of 68 patients, 34 of whom were in the control group and 34 in the experimental group, who underwent total knee prothesis surgery in the orthopedics and traumatology service at Bartın State Hospital between September 2022 and June 2023. Research data will be collected with Participant Information Form, Brief Pain Inventory, Patient Mobility Scale and Observer Mobility Scale. During the data collection process, the pain level of the experimental group will be evaluated at the 8th hour after the operation, then the level of mobility will be evaluated by providing mobilization. The control group will only be evaluated for pain at the 8th hour after surgery, and they will not be mobilized. At the 20th hour after the surgery, pain assessment of both groups will be made, and then their mobility will be evaluated, and their mobility levels will be evaluated. SPSS 22.0 program will be used in the evaluation of the data. Whether the data is normally distributed or not will be tested by Shapiro-wilk analysis. According to the result of this, parametric and nonparametric methods will be used.
Detailed description
Introduction: Pain development is an expected situation in individuals who have undergone total knee replacement surgery. Again, in these patients, the tendency to stay still increases due to the surgery and pain. International guidelines and other studies indicate that early mobilization of patients after surgical interventions is effective in preventing complications that can be caused by inactivity and reducing the severity of pain in patients. Early mobilization gains importance in order to accelerate the recovery process of patients after total knee replacement surgery and to prevent problems such as muscle mass loss and muscle weakness that may arise from long-term bed rest.
Objective: This study will be conducted to determine the effect of early mobilization on pain and mobility levels in patients who underwent total knee replacement.
Method: This study, which was designed as a randomized controlled experimental type, will be conducted with a total of 68 patients, 34 of whom were in the control group and 34 in the experimental group, who underwent total knee replacement surgery in the orthopedics and traumatology service at Bartın State Hospital between September 2022 and June 2023. Research data will be collected with Participant Information Form, Brief Pain Inventory, Patient Mobility Scale and Observer Mobility Scale. The patients in the experimental group will not be mobilized until the 8th hour, and their first mobilization will be carried out at the 8th hour. The pain levels of the patients in the experimental group at the 8th hour will be evaluated with the Brief Pain Inventory and their mobilization will be ensured. Mobility levels after mobilization will be recorded by evaluating with the Patient Mobility Scale and by the research nurse who mobilized the patient with the Observer Mobility Scale. Patients in the control group will not be mobilized until the 20th hour after surgery. Patients will be evaluated only for pain at the 8th hour after surgery. The first mobilizations will be made at the 20th hour after the surgery, and their mobility levels will be evaluated with the Observer Mobility Scale and the Patient Mobility Scale by both the patient and the researching nurse who mobilized them. Pain assessment will be performed in both groups at the 20th hour and then their mobility will be evaluated. SPSS 22.0 program will be used in the evaluation of the data. Whether the data is normally distributed or not will be tested by Shapiro-wilk analysis. According to the result of this, parametric and nonparametric methods will be used.
Conclusion: If the research is carried out successfully, the differences caused by early mobilization in the pain levels and mobility levels of the patients will be revealed. The fact that early mobilization causes a decrease in the level of pain, as stated in the literature, will enable patients to be mobilized earlier. Again, if early mobilization has a positive effect on the mobility level of the patients, the patients will be able to be mobilized early for this purpose.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | –* After randomization, 34 patients will be included in the experimental group. This group is the group to be mobilized early after surgery. * During the data collection process, the pain level of the experimental group will be evaluated at the 8th hour after the operation, then the level of mobility will be evaluated by providing mobilization. * At the 20th hour after the surgery, pain assessment of both groups will be made, and then their mobility will be evaluated, and their mobility levels will be evaluated. |
| Control Group | – | –* After randomization, 34 patients will be included in the control group. This group is the group that did not undergo early mobilization. * The control group will only be evaluated for pain at the 8th hour after surgery, and they will not be mobilized. * At the 20th hour after the surgery, pain assessment of both groups will be made, and then their mobility will be evaluated, and their mobility levels will be evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who were hospitalized in the orthopedics and traumatology service of Bartın State Hospital and who had undergone total knee replacement surgery constitute the scope of this study.
Key inclusion criteria (3 listed)
- Having a total knee replacement surgery
- Volunteering
- Being over 18 years old
Key exclusion criteria (2 listed)
- Not volunteering
- Patients for whom early mobilization is contraindicated (without physician approval)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pain status
Time frame: 8 hours
At the 8th hour, the pain status of the patients in the control and experimental groups will be evaluated with the Brief Pain Inventory. Brief Pain Inventory; It is a form consisting of 9 questions in total. The first question compares the individual's pain with past pain experiences, the second question includes an image where the individual will mark the pain area. The next four questions serve to measure pain intensity with a numerical pain scale. Numerical pain scale is evaluated in the range of 0-10. "0" means no pain, "10" means unbearable pain. The last question evaluates the level of influence of factors such as mobility, emotional state, breathing, coughing exercise, interpersonal relations, walking, working and enjoying life, sleep, due to pain in the last 24 hours, with a value in the range of 0-10. "0" means not affected at all, "10" means completely affected. The higher the score, the higher the pain intensity.
level of mobility
Time frame: 8 hours
At the 8th hour, the mobility levels of the patients in the control and experimental groups will be evaluated with the Observer Mobility Scale. Observer Mobility Scale: While performing four activities after surgery, dependency/independence status and degree are evaluated between 1 and 5. 1 indicates that the patient cannot perform the activity independently without the need for verbal stimulation or physical assistance, and 5 indicates that the patient cannot perform the activity even with verbal stimulation or physical assistance. As a result, the Global Patient Mobility score is obtained by summing the scores of all activities. The minimum and maximum score that can be obtained from the scale is between 1-5, and the total score is between 4-20. An increase in the score indicates that the patient's mobility skills are insufficient, and a decrease in the score indicates that the patient's mobility is sufficient after the surgery.
pain status
Time frame: 20 hours
At the 20th hour, the pain status of the patients in the control and experimental groups will be evaluated with the Brief Pain Inventory. Brief Pain Inventory; It is a form consisting of 9 questions in total. The first question compares the individual's pain with past pain experiences, the second question includes an image where the individual will mark the pain area. The next four questions serve to measure pain intensity with a numerical pain scale. Numerical pain scale is evaluated in the range of 0-10. "0" means no pain, "10" means unbearable pain. The last question evaluates the level of influence of factors such as mobility, emotional state, breathing, coughing exercise, interpersonal relations, walking, working and enjoying life, sleep, due to pain in the last 24 hours, with a value in the range of 0-10. "0" means not affected at all, "10" means completely affected. The higher the score, the higher the pain intensity.
level of mobility
Time frame: 20 hours
At the 20th hour, the mobility levels of the patients in the control and experimental groups will be evaluated with the Patient Mobility Scale. Patient Mobility Scale: It is applied to evaluate the level of pain and difficulty in performing the four activities: turning from one side to the other in the bed, sitting by the bed, standing up by the bed and walking in the patient's room after the surgery. The numerical value of the degree of pain and difficulty is determined by measuring the distance between the mark on the scale and zero with a calibrated ruler. There are two subgroup questions for each activity. The questions are answered as 1 to 5 to determine the level and severity of pain perception, 1 was no pain, 5 was the worst pain I could imagine, and the difficulty levels of the activities were between 1 and 5, 1 was very easy, 5 was very difficult. As a result, the Global Patient Mobility score is obtained by summing the scores of all activities.
2 secondary outcomes
pain levels
Time frame: 0-20 hours
mobility levels
Time frame: 0-20 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
Related trials for Early Ambulation
Not yet recruiting
Early Ambulation Safety Evaluation, Ultrasound-guided Percutaneous Venous Closure
Catheter Ablation, Radiofrequency
Recruiting
Slow-SPEED: Slowing Parkinson's Early Through Exercise Dosage
Parkinson Disease, Prodromal Stage
Active, not recruiting
Early Rehabilitation in Patients Following Major Cardiac Surgery: Changes in Functional Capacity and Energy Efficiency in Walking and ADLs.
Cardiac Surgery, Median Sternotomy
Not yet recruiting
Early Ambulation Safely in Unstable Ankle Fractures (EASY-Ankle)
Trimalleolar Ankle Fracture, Unstable Trimalleolar Ankle Fracture
Not yet recruiting
Postprocedural Bed-Rest Strategies After Transfemoral Venous Interventions
Venous Access, Endovascular Procedures
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.
Mediha Didem KOCOGLU study chair
Bartın Unıversity
Questions about this trial
What is this clinical trial studying?
An observational study of Early Ambulation, run by Bartın Unıversity.
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 3 inclusion and 2 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 20 Oct 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?
Contact Mediha Didem KOCOGLU (5070300248, mdidemkocoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain status (time frame: 8 hours). 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?
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 20 Oct 2022.