First Mobilization Protocol for Total Knee Arthroplasty Patients

NCT06268899 | Completed DMC

• 1 other identifier: E-77082166-302.08.01-285977
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthroplasty

Keywords

Total Knee Arthroplasty; Nursing; Mobilization; Ambulation; First Mobilization Protocol; Orthopaedic and trauma nursing; Anxiety; Kinesiophobia; Mobilization related symptoms

Outcome Measures

Primary Outcomes (4)

• Anxiety evaluated using the Trait Anxiety Inventory (Trait Anxiety Inventory, TAI)

  The "Trait Anxiety Inventory (STAI FORM TX-2, SDS)" allows the individual to express how he or she generally feels. the emotions and behaviors expressed in the scale items are according to their degrees; It is marked as (1) Almost Never, (2) Sometimes, (3) Often, and (4) Almost Always. 0-19 points from the scale mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.

  Change Trait Anxiety scale points on one day

• Kinesiophobia evaluated using the Tampa Kinesiophobia Scale

  The Tampa Kinesiophobia Scale (TKS) was used to evaluate the patients' fear of moving. The scale consists of 17 items and has a Likert type feature. Scale items are used in the form of 4-point Likert scoring (1=Strongly disagree, 2=Disagree, 3=Agree, 4=Completely agree) and the total score ranges from 17-68. A high score from the scale indicates a high fear of movement. It is recommended to use the total score obtained from the scale in studies. It was stated that the test-retest reliability was 0.81.

  Change Kinesiophobia scale points on two days

• Anxiety evaluated using the State Anxiety Inventory (State Anxiety Inventory, SAI)

  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 Trait and State-Anxiety scale points on one day

• Symptoms evaluated using the Numerical Rating Scale for Symptoms Related to First Mobilization

  Patients' symptoms related to the first mobilization (pain, dizziness, nausea, blackout, anxiety, stress, fear of damaging the surgery site, fear of falling, inability to walk/movement, walking distance on the first day, walking distance at the end of the first day, total walking at the end of the first day) distance, total mobilization per day, orthostatic intolerance, orthostatic hypotension) will be scored using a Numerical Comparison Scale from 0-10. This form will be used before and after mobilization on the day of the first mobilization of the patients.

  Change symptoms points on one day

Study Arms (2)

First mobilization protocol

EXPERIMENTAL

The protocol phases start one day before the patient's surgery and end on the first day of mobilization after surgery. The investigator explains the protocol steps to the patient before surgery and the patient is mobilized within the first 24 hours after surgery. Perform the protocol 4 times a day and more as tolerated. Mobilization protocol: Level 1: Patient is informed about mobilization and readiness is reinforced. Level 2: Passive and active ROM movements in bed should be performed at least 3 times a day. Level 3: Head of bed \>60 degrees when the patient is sitting in bed. Duration target: 10-15 minutes. Level 4: Patient is seated on the edge of the bed. Duration target: 10-15 minutes. Level 5: The patient is helped to stand up. Level 6: First mobilization is achieved by allowing the patient to take 10-15 steps. The patient can mobilize at least 4 times a day.

Other: First 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

First mobilization protocol OTHER

The protocol phases start one day before the patient's surgery and end on the first day of mobilization after surgery. The investigator explains the protocol steps to the patient before surgery and the patient is mobilized within the first 24 hours after surgery. Perform the protocol 4 times a day and more as tolerated. Mobilization protocol: Level 1: Patient is informed about mobilization and readiness is reinforced. Level 2: Passive and active ROM movements in bed should be performed at least 3 times a day. Level 3: Head of bed \>60 degrees when the patient is sitting in bed. Duration target: 10-15 minutes. Level 4: Patient is seated on the edge of the bed. Duration target: 10-15 minutes. Level 5: The patient is helped to stand up. Level 6: First mobilization is achieved by allowing the patient to take 10-15 steps. The patient can mobilize at least 4 times a day.

First mobilization protocol

Eligibility Criteria

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

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead
• Baskent University: collaborator

Study Sites (1)

Gazi University Health Research and Application Center

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Kinesiophobia

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders

Study Officials

• Ayse Gul ATAY DOYGACI, Master

  Baskent Unversity

  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: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: January 8, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)