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NCT Number: NCT06758297

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsun Gazi State Hospital

Samsun, 55000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Hatice Merve Alptekin research assistant

CONTACT

[email protected]

+902623034733

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI-Powered Motivational Speech

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hatice Merve Alptekin research assistant

CONTACT

[email protected]

+90262303004733

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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