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First Mobilization Protocol for Total Knee Arthroplasty Patients

NCT ID: NCT06268899

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-08

Study Completion Date

2024-03-30

Brief Summary

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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

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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.

Conditions

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Knee Arthroplasty

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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First mobilization protocol

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.

Group Type EXPERIMENTAL

First mobilization protocol

Intervention Type 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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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First mobilization protocol

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role collaborator

Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Sevil Güler

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayse Gul ATAY DOYGACI, Master

Role: PRINCIPAL_INVESTIGATOR

Baskent Unversity

Locations

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Gazi University Health Research and Application Center

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E-77082166-302.08.01-285977

Identifier Type: -

Identifier Source: org_study_id