Mobilization Protocol for Knee Arthroplasty Patients

NCT05679947 | Completed DMC

• 1 other identifier: E-77082166-604.01.02-140038
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain; Anxiety; Physical Function; Mobility; Arthroplasty

Keywords

knee arthroplasty; nursing; mobilization protocol; patient outcome; nurse sensitive outcomes; orthopaedic and trauma nursing

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Mobilization Protocol

EXPERIMENTAL

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.

Other: Mobilization protocol

Control

NO INTERVENTION

No intervention was made to the control group, only data were collected at the same time as the study group.The patients in the control group was mobilized by the researchers according to the routine clinical mobilization practice.

Interventions

Mobilization protocol OTHER

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.

Mobilization Protocol

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead
• Bozok University: collaborator

Study Sites (2)

Turkey, Yozgat Bozok University, Yozgat Cıty Hospıtal

Yozgat, Turkey (Türkiye)

Location

Yozgat Bozok University, Yozgat Cıty Hospıtal

Yozgat, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Sevinç Meşe, MASTER

  Yozgat Bozok Universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant: the researcher learned the study and control groups after the pre-test data. The study group was trained with the mobilization protocol. The control group received training on the current mobilization procedure of the clinic. Participants did not know which group they were in. Outcomes Assessor. Study and control groups data were coded into the SPSS programme as group one and group two. Analysis of data was done by an independent statistician. The statistician has no information about which group the patients belong to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Prospective, parallel group single blinded, randomized controlled clinical trial

Study Record Dates

• First Submitted: December 18, 2022
• First Posted: January 11, 2023
• Study Start: May 1, 2022
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)