Mobilization Protocol for Knee Arthroplasty Patients

Pain Clinical Trial

— KA-Mobility  

Official title:

The Effect of Mobilization Protocol Developed for Knee Arthroplasty Patients on Nursing Care-Sensitive Patient Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05679947
• Other study ID #: E-77082166-604.01.02-140038
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 28, 2022

Study information

• Verified date: February 2024
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 28, 2022
• Est. primary completion date: September 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Anxiety
• Arthroplasty
• Mobility
• Pain
• Physical Function

Intervention

Other:
• Mobilization protocol
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.

Locations

Country	Name	City	State
Turkey	Turkey, Yozgat Bozok University, Yozgat City Hospital	Yozgat
Turkey	Yozgat Bozok University, Yozgat City Hospital	Yozgat

Sponsors (2)

Lead Sponsor	Collaborator
Gazi University	Bozok University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change State-Anxiety scale points at 3 weeks
Primary	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.	Change Pain scale points at 3 weeks
Primary	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.	Change KOOS-PS scale points at 3 weeks
Primary	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.	Change Patient Mobility scale scores at 2 days
Primary	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.	Change Observer Mobility scale scores at 2 days