The Effect of Early Mobilization on Pain and Mobility Levels

NCT05587985 | Unknown

• 1 other identifier: 2022-SBB-0345
• Study Type: observational
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Early Ambulation

Keywords

Total knee replacement; early mobilization; pain

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• pain levels

  0-20 hours

• mobility levels

  0-20 hours

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Having a total knee replacement surgery
• Volunteering
• Being over 18 years old

You may not qualify if:

• Not volunteering
• Patients for whom early mobilization is contraindicated (without physician approval)

Sponsors & Collaborators

• Bartın Unıversity: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mediha Didem KOCOGLU

  Bartın Unıversity

  STUDY CHAIR

Central Study Contacts

Mediha Didem KOCOGLU

CONTACT

5070300248; mdidemkocoglu@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 20, 2022
• Study Start: November 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 20, 2022

Record last verified: 2022-10