Mobilization Protocol for Knee Arthroplasty Patients

Not Applicable

Completed

• Conditions: Anxiety; Pain; Physical Function; Mobility; Arthroplasty
• Interventions: Other: Mobilization protocol

• Registration Number: NCT05679947
• Lead Sponsor: Gazi University

Brief Summary

This randomized controlled study evaluates the effect of mobilization protocol applied to knee arthroplasty patients on anxiety level, pain, mobility and functional status.

Detailed 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.

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2022-09-28
• Study Completion: 2022-09-28
• Study First Submitted: 2022-12-18
• Study First Submitted QC: 2022-12-24
• Study First Posted: 2023-01-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobilization Protocol	Mobilization protocol	The study group patients were mobilized according to the developed mobilization protocol.The protocol includes six levels. Protocol levels are applied from the day the patient is operated and ends on the discharged day. The researcher explains the protocol levels to the patient before surgery.The patient is mobilized within the first 24 h after surgery. Implement mobilization protocol 3 times during the day and more as tolerated. Mobilization protocol:Level 1: Repositioning should occur every 2 h. Level 2: ROM should occur at least 3 times a day. Level 3: The head of bed (HOB) \>30 degrees. Duration goal: 5-15 min. HOB 65≥ degrees with patient sit in the bed. Duration goal: 5-15 min. Progress to level 4. Level 4: HOB 65≥ degrees with legs in dependent position (recliner chair). Duration goal: 5-15 min. Progress to level 5. Level 5: Stand/pivot/step to chair. Sitting in chair. Duration goal: 5-15 min. Progress to level 6. Level 6: Patient is able to ambulate at least 3 times a day.

Primary Outcome Measures

Name	Time	Method
Anxiety evaluated using the State Anxiety Inventory	Change State-Anxiety scale points at 3 weeks	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
Physical function evaluated using knee injury and osteoarthritis outcome score-physical function short-form (KOOS-PS)	Change KOOS-PS scale points at 3 weeks	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.
Patient Mobility Scale	Change Patient Mobility scale scores at 2 days	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.
Pain evaluated using the Vizüel Analog Scale (VAS)	Change Pain scale points at 3 weeks	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.
Observer Mobility Scale	Change Observer Mobility scale scores at 2 days	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.

Trial Locations

Locations (2)

Yozgat Bozok University, Yozgat Cıty Hospıtal; 🇹🇷 Yozgat, Turkey

Turkey, Yozgat Bozok University, Yozgat Cıty Hospıtal; 🇹🇷 Yozgat, Turkey