Clinical trial NCT05679947: Mobilization Protocol for Knee Arthroplasty Patients
Official title: The Effect of Mobilization Protocol Developed for Knee Arthroplasty Patients on Nursing Care-Sensitive Patient Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Physical Function
Mobility
Arthroplasty
Keywords: knee arthroplasty
nursing
mobilization protocol
patient outcome
nurse sensitive outcomes
orthopaedic and trauma nursing
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: Bozok University
First posted: 2023-01-11
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel group single blinded, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety evaluated using the State Anxiety Inventory
timeFrame: Change State-Anxiety scale points at 3 weeks
measure: Pain evaluated using the Vizüel Analog Scale (VAS)
timeFrame: Change Pain scale points at 3 weeks
measure: Physical function evaluated using knee injury and osteoarthritis outcome score-physical function short-form (KOOS-PS)
timeFrame: Change KOOS-PS scale points at 3 weeks
measure: Patient Mobility Scale
timeFrame: Change Patient Mobility scale scores at 2 days
measure: Observer Mobility Scale
timeFrame: Change Observer Mobility scale scores at 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Turkey, Yozgat Bozok University, Yozgat Cıty Hospıtal
city: Yozgat
country: Turkey
facility: Yozgat Bozok University, Yozgat Cıty Hospıtal
Study officials:
affiliation: Yozgat Bozok Universty
name: Sevinç Meşe, MASTER
role: PRINCIPAL_INVESTIGATOR
References: