Clinical trial NCT06268899: First Mobilization Protocol for Total Knee Arthroplasty Patients
Official title: Evaluation of the Effectiveness of the Fırst Mobilization Protocol Developed for Knee Arthroplasty Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroplasty
Keywords: Total Knee Arthroplasty
Nursing
Mobilization
Ambulation
First Mobilization Protocol
Orthopaedic and trauma nursing
Anxiety
Kinesiophobia
Mobilization related symptoms
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: Baskent University
First posted: 2024-02-20
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study protocol describes the design of a single-center, single-blind, statistician-blind randomized controlled trial to be conducted in the Orthopedics and Traumatology Clinic of a provincial university hospital in Turkey.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This single blinded randomized controlled study evaluates the effect of developed First Mobilization Protocol applied to knee arthroplasty patients on state anxiety, kinesiophobia, initial mobilization related symptoms.

Detailed description: Ensuring the mobilization of patients in the postoperative period, preventing complications resulting from inactivity, maintaining homeostatic balance and accelerating recovery are among the important goals of nursing care. For this reason, it is necessary to gradually increase the patients in line with the evidence-based data and the importance of mobilization should be emphasized. In this study, it was aimed to develop the first mobilization protocol for patients undergoing total knee arthroplasty and to evaluate the effectiveness of the developed protocol on patients' state anxiety, kinesiophobia, initial mobilization related symptoms.

The research is planned to be conducted in the Orthopedics and Traumatology Clinic of a university hospital in Turkey. The protocol of the study will be completed with78 patients who meet the sampling criteria (39 interventions, 39 controls), although it was designed as a single-center, single-blind randomized controlled and prospective study. Patient Information Form, State-Trait Anxiety Inventory, Tampa Kinesiophobia Scale and Initial Mobilization-Related Symptoms Evaluation Form will be used to collect the data of the study. Study; It is a single-center and single-blind randomized controlled experimental study protocol.

The data obtained within the scope of the study will be explained after being collected and analyzed. The effectiveness of the first mobilization protocol developed for tolal knee arthroplasty patients will be evaluated.

Eligibility criteria: Inclusion Criteria:

* 18 years and older,
* First time knee arthroplasty surgery,
* Have not received a diagnosis that will prevent communication,
* No physical disability,
* Mobilized during the implementation process of the research,
* Bilateral arthroplasty surgery is not performed,

Exclusion Criteria:

* Revision surgery performed,
* Patients who have undergone total hip or knee arthroplasty before,
* Inability to perform or delay mobilization due to complication(s) developed in the postoperative period,
* The patient cannot be mobilized on the first postoperative day (in the first 48 hours),
* Desire to leave the research voluntarily.

Primary outcomes:
measure: Anxiety evaluated using the Trait Anxiety Inventory (Trait Anxiety Inventory, TAI)
timeFrame: Change Trait Anxiety scale points on one day
measure: Kinesiophobia evaluated using the Tampa Kinesiophobia Scale
timeFrame: Change Kinesiophobia scale points on two days
measure: Anxiety evaluated using the State Anxiety Inventory (State Anxiety Inventory, SAI)
timeFrame: Change Trait and State-Anxiety scale points on one day
measure: Symptoms evaluated using the Numerical Rating Scale for Symptoms Related to First Mobilization
timeFrame: Change symptoms points on one day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Health Research and Application Center
Study officials:
affiliation: Baskent Unversity
name: Ayse Gul ATAY DOYGACI, Master
role: PRINCIPAL_INVESTIGATOR
References: