NCT06758297

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

December 30, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

December 26, 2024

Last Update Submit

March 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Kinesiophobia

    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 Outcomes (1)

  • Mobility Level

    Simultaneously when the patient first stands up (approximately the 2nd postoperative day)

Study Arms (2)

AI-Powered Motivational Speech Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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".

Interventions

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.

AI-Powered Motivational Speech Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun Gazi State Hospital

Samsun, Samsun, 55000, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Hatice Merve Alptekin research assistant

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

December 26, 2024

First Posted

January 3, 2025

Study Start

December 30, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations