Effect of Artificial Intelligence-Assisted Motivational Talk on Patients' Fear of Movement and Mobility Level After Knee Replacement

March 24, 2025 updated by: Hatice Merve Alptekin, Kocaeli University

Effect of Artificial Intelligence-Assisted Motivational Talk on Patients' Fear of Movement and Mobility Level After Knee Replacement: a Randomized Controlled Trial

Patients may have fears about moving after TKA surgery. This fear has been described in the literature. Fear of re-injury has also been called kinesiophobia, which is the primary psychosocial structure in the fear-avoidance model. Injury or surgery can create feelings of uncertainty and fear of how much the injury will affect future function. This situation causes the individual to have negative attitudes towards activity. For this reason, kinesiophobia is a psychological element that can affect patient outcomes and recovery after knee trauma or knee surgery. Kinesiophobia is considered a normal reaction in the early postoperative period. However, it can affect patients' early mobility after TKA. It is important to improve functional outcomes in the early period, especially in knee surgeries. Patients may delay mobilization because they feel a fear of falling after surgery, and as this delay increases, their mobility is affected worse. The only solution to this situation, which can enter a vicious circle, is to determine patients' fear of falling and apply interventions accordingly. There are studies in the literature evaluating the fear of movement after total knee arthroplasty and its effect on patients' mobility levels. However, no study has been found investigating the effect of a motivational speech prepared with the help of artificial intelligence on patients. The World Health Organization (WHO) has published a four-year global strategy report on digital health within the scope of the vision of health everywhere and for everyone. According to this report, digital health is defined as "the adoption of digital technologies to improve and develop health". The use of artificial intelligence technology is increasing day by day in the changing and developing world. It is known that nurses constitute 45% of all health professionals in the field of health and that insufficient staff number continues to be a priority problem. It is expected that insufficient staff will be supported and efficiency will increase with the contribution of artificial intelligence, which is the copy of human intelligence with advanced technology. With this research, we aim to both support staff and improve patient outcomes by using artificial intelligence technologies. The aim of this study is to evaluate the effect of an artificial intelligence-supported motivational speech on patients' fear of movement and mobility level after knee replacement.

Study Overview

Status

Status

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

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 (Estimated)

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.
76

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
      • Samsun, Turkey, 55000
        • Recruiting
        • Samsun Gazi State Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patient must have had knee replacement surgery,
  • Be over 18 years of age,
  • Agree to participate in the study,
  • Be able to understand and speak Turkish,
  • Be able to read and write

Exclusion Criteria:

  • Cancellation or postponement of patient's surgery
  • Patients in pain,
  • Those whose walking is not recommended by the physician,
  • Those with mental disabilities or psychological disorders,
  • Patients who are alcohol or drug addicts,
  • Those with hearing or visual impairments,
  • Patients who do not want to use the headphones that will be used in the study.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: AI-Powered Motivational Speech Group
  1. Patients will be assessed for fear of falling using the "Descriptive Characteristics Form" and the "TAMPA Kinesiophobia Scale".
  2. The audio recording prepared with artificial intelligence support will be listened to 3 times.

4. . Patients will be assessed for fear of falling again using the "TAMPA Kinesiophobia Scale".

5. While the patients are standing up, the researcher will measure their mobility levels using the "Patient Mobility and Observer Mobility Scale".
Other: AI-Powered Motivational Speech
It is known that patients with knee prosthesis have difficulty in the first standing process due to fears of falling, not being able to walk again, and recurrence of their disease. For this purpose, a speech text that will motivate patients was prepared with the support of "ChatGPT". Expert opinions were obtained from 2 orthopedic specialists and 2 specialist psychiatric nurses for this speech text. Later, the speech text was converted into an audio video with the "ElevenLabs" application. Thus, it was planned to make it easier for patients to listen to it again. Patients will listen to this motivational speech in their own patient rooms and using their own headphones.
No Intervention: Control Group
  1. Patients will be assessed for fear of falling using the "Descriptive Characteristics Form" and the "TAMPA Kinesiophobia Scale".
  2. After 15 minutes, patients will be assessed for fear again using the "TAMPA Kinesiophobia Scale".
  3. While the patients are being stood up, the researcher will measure their mobility levels using the "Patient Mobility and Observer Mobility Scale".

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
Kinesiophobia
Time Frame: 20 minutes before the patient starts walking, 5 minutes before the patient starts walking
The patients' fear of falling will be evaluated with the TAMPA Kinesiophobia Scale. The scale is a 17-question scale developed to determine the level of injury/re-injury and fear-avoidance processes related to activities. The scale is scored with a four-point Likert scoring type of "1=Strongly Disagree", "2=Disagree", "3=Agree", "4=Strongly Agree". The minimum score value obtained from the scale is 17, while the maximum score value is 68. Vlaeyen et al. accepted a score above 37 from the scale as a high level of kinesiophobia.
20 minutes before the patient starts walking, 5 minutes before the patient starts walking

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mobility Level
Time Frame: Simultaneously when the patient first stands up (approximately the 2nd postoperative day)
The patient's mobility will be assessed with the Patient Mobility and Observer Mobility Scales. The scale is a 5-point Likert-type scale with a 5-point score ranging from "It was very easy" to "It was very difficult". In the Mobility Scale, the dependency/independence status/degree during the performance of four activities after surgery is numbered between 1 and 5. A score of 1 indicates that the patient performed the relevant activity independently without verbal warning or physical assistance, and a score of 5 indicates that the patient could not perform the relevant activity despite verbal warning or physical assistance. The total score is calculated by adding the scores for turning, sitting, standing and walking. A total score of 4-20 is obtained from the scale. An increase in the score indicates that the patient's movement skills are inadequate, and a decrease in the score indicates that their movement skills after the surgical intervention are good/sufficient.
Simultaneously when the patient first stands up (approximately the 2nd postoperative day)

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.
Kocaeli 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.
December 30, 2024

Primary Completion (Estimated)

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.
June 30, 2025

Study Completion (Estimated)

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.
June 30, 2025

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 26, 2024

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 26, 2024

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.
March 25, 2025

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.
March 25, 2025

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.
March 24, 2025

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.
March 1, 2025

More Information

Terms related to this study

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.
  • 2025/01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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