The Effect of Early Mobilization on Pain and Mobility Levels

Early Ambulation Clinical Trial

Official title:

The Effect of Early Mobilization on Pain and Mobility Levels in Patients Undergoing Total Knee Prothesis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05587985
• Other study ID #: 2022-SBB-0345
• Status: Not yet recruiting
• Start date: November 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2022
• Source: Bartin University
• Contact: Mediha Didem KOCOGLU
• Phone: 5070300248
• Email: mdidemkocoglu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: October 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having a total knee replacement surgery

• Volunteering

• Being over 18 years old

Exclusion Criteria:

• Not volunteering

• Patients for whom early mobilization is contraindicated (without physician approval)

Related Conditions & MeSH terms

• Early Ambulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bartin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 hours
Primary	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.	8 hours
Primary	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.	20 hours
Primary	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.	20 hours
Secondary	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,	0-20 hours
Secondary	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.	0-20 hours