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Completed

NCT Number: NCT05679947

Mobilization Protocol for Knee Arthroplasty Patients

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

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Key information

Conditions

Pain Anxiety Anxiety Disorders Arthroplasty Mental Disorders Mobility Neurologic Manifestations Pathological Conditions, Signs and Symptoms Physical Function Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turkey, Yozgat Bozok University, Yozgat Cıty Hospıtal, Yozgat, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Anxiety evaluated using the State Anxiety Inventory

    Time frame: 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

  2. Pain evaluated using the Vizüel Analog Scale (VAS)

    Time frame: 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.

  3. Physical function evaluated using knee injury and osteoarthritis outcome score-physical function short-form (KOOS-PS)

    Time frame: 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.

  4. Patient Mobility Scale

    Time frame: 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.

  5. Observer Mobility Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Collaborators

  • Bozok University

Registry information

Official study title

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

Acronym: KA-Mobility

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2023
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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