Clinical trial NCT05587985: The Effect of Early Mobilization on Pain and Mobility Levels
Official title: The Effect of Early Mobilization on Pain and Mobility Levels in Patients Undergoing Total Knee Prothesis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Ambulation
Keywords: Total knee replacement
early mobilization
pain
Lead sponsor: Bartın Unıversity
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: pain status
timeFrame: 8 hours
measure: level of mobility
timeFrame: 8 hours
measure: pain status
timeFrame: 20 hours
measure: level of mobility
timeFrame: 20 hours
Secondary outcomes:
measure: pain levels
timeFrame: 0-20 hours
measure: mobility levels
timeFrame: 0-20 hours
Other outcomes:
Locations:
Study officials:
affiliation: Bartın Unıversity
name: Mediha Didem KOCOGLU
role: STUDY_CHAIR
References: