The Effect of Mobile-based Education and Exercise Program Given to Patients With Total Knee Replacement Surgery

December 22, 2023 updated by: Alkay Kara

The Effect of Mobile-based Education and Exercise Program Given to Patients With Total Knee Replacement Surgery on Anxiety, Kinesiophobia, and Physical Function

Total knee replacement (TDP) surgery is recognized as an effective surgical option for patients who develop moderate to severe osteoarthritis of the knee. Before, during and after TDP surgery, patients experience physical, psychological and social problems. After TDP surgery, patients may experience problems such as dependency and sleep problems in their daily living activities. Patients who have sleep problems, who cannot rest enough, become tired and experience anxiety as a result. It has been stated that the education given to the patients in the preoperative period reduces anxiety and analgesic needs and increases satisfaction. Progressive relaxation exercises in patients It has been shown to be effective in reducing symptoms such as anxiety, pain and fatigue. With the widespread use of mobile technologies, a rapid development is observed in mobile health applications and it is thought that its use in the field of health will provide great benefits to nursing services. This study is of the randomized controlled experimental type. During the application process, a mobile-based training and exercise program will be applied to the patients in the experimental group. As the education content, information about pre- and post-operative information and video-supported training content that will guide the patients with voice commands about the exercises that the patients will do before the surgery will be included in the mobile application. With the implementation of this program, continuity will be ensured by meeting the information needs of the patients before and after the surgery, and by performing progressive relaxation and knee exercises correctly and regularly. With the use of this mobile application, it is aimed to increase the physical functions of the patients by reducing the level of anxiety and fear of movement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Giresun, Turkey
        • Giresun University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who were decided to undergo total knee replacement surgery with the diagnosis of osteoarthritis,
  • Patients who will undergo elective surgery
  • Patients who will undergo unilateral total knee replacement surgery for the first time
  • Patients who can be communicated verbally
  • Patients without any psychiatric disease
  • Patients who use smartphones and agree to participate in the study

Exclusion Criteria:

  • Patients under the age of 18
  • Patients who have had previous total knee replacement surgery
  • Patients who underwent total knee replacement with emergency surgery
  • Patients who will undergo bilateral total knee replacement surgery
  • Patients with a previous psychiatric diagnosis
  • Patients with verbal communication disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mobile-based education and exercise program
Mobile-based education and progressive relaxation and knee exercise program will be applied to the patients in the experimental group.
Other: The mobile-based education and exercise program
Starting from the preoperative period, mobile-based patient education, progressive relaxation exercise and knee exercise program will be applied to the patient as a whole. Mobile-based education will include pre-operative and discharge education. The patient will be given a progressive relaxation exercise with the support of the mobile application and the exercises included in the knee exercise program that should be done after the surgery will be shown. Progressive relaxation exercises will be applied twice a day in the afternoon and evening. Postoperative knee exercises will be performed 3 to 5 times a day, depending on the type of exercise. These exercises will be continued regularly for up to 4 weeks after discharge.
No Intervention: Standard of care
Mobile-based education and progressive relaxation and knee exercise program will not be applied to the patients in the control group, and the clinical routine will be maintained.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Scale
Time Frame: 4 weeks

The scale consists of two parts, a 20-item "state anxiety form" designed to determine what is felt at the moment, and a 20-item "trait anxiety form" designed to determine what is felt in general.

It is a four-degree scale ranging from "Not at all" to "Totally". Scores range from 20 (low anxiety) to 80 (high anxiety).
4 weeks
Tampa Scale for Kinesiophobia
Time Frame: 4 weeks
The scale consists of 17 items. The scale is a 4-point Likert type (1 = I strongly disagree, 4 = I completely agree) is used. The total score varies between 17-68. A high score on the scale indicates knesiophobia.
4 weeks
Knee injury and osteoarthritis outcome score-physical function short-form
Time Frame: 4 weeks
The KOOS-PS scale consists of seven items. The items are intended to measure the degree of functionality of normal daily activities and more challenging activities. Each item scores between 0 "no difficulty" and 4 "very severe difficulty". The raw score is the sum of the scores given to these seven questions and ranges from 0 to 28. Higher scores indicate worse physical function.
4 weeks
Visual Analog Scale
Time Frame: 4 weeks
The Visual Analog Scale is a widely used scale for the assessment of pain in patients. The patient marks his or her own pain on a 10 cm ruler with the words 'no pain' on one end and 'unbearable pain' on the other end.
4 weeks
Visual Analog Sleep Scale
Time Frame: 4 weeks
This Visual Analog Sleep Scale measures the sleep quality of individuals. Each item in the scale is evaluated on a chart between 0 (left end) and 100 (right end) using the visual comparison technique. Scale scoring ranges from 0 to 1000. An increase in the score obtained from the scale indicates a decrease in sleep quality.
4 weeks
The Turkish Version of the Computer System Usability Questionnaire-Short Version
Time Frame: 4 weeks
This questionnaire evaluates the usability of a software system with 13 items. Each item is scored as 1 (Strongly agree) - 7 (Strongly disagree).
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alkay Kara

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Neziha Karabulut, PhD, Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-KARA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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