- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07694895
"The Effect of AI-Assisted Mobilization Education on Kinesiophobia and Readiness for Hospital Discharge in Patients Undergoing Total Knee Arthroplasty''
The aim of this study is to investigate the effect of artificial intelligence-assisted mobilization education provided to patients undergoing total knee arthroplasty on their level of kinesiophobia and readiness for hospital discharge.
The research questions are as follows:
Does artificial intelligence-assisted mobilization education provided to patients undergoing total knee arthroplasty affect their level of kinesiophobia? Does artificial intelligence-assisted mobilization education provided to patients undergoing total knee arthroplasty affect their readiness for hospital discharge? Study Procedure In the control group, participants will receive the standard care routinely provided in the orthopedic clinic, without viewing the artificial intelligence-assisted mobilization education video. In the intervention group, participants will receive an artificial intelligence-assisted video-based mobilization education program developed to prepare them for their first postoperative mobilization.
Intervention Group:
After hospital admission, participants will complete a Personal Information Form. On postoperative day 1, before the first mobilization, the Tampa Scale for Kinesiophobia will be administered. Following completion of the baseline assessment, participants will receive the artificial intelligence-assisted video-based mobilization education delivered by a nurse. Immediately after the education, the Tampa Scale for Kinesiophobia will be administered again. Four hours before hospital discharge, participants will complete the Readiness for Hospital Discharge Scale-Patient Self-Assessment Form, and the nurse will complete the Readiness for Hospital Discharge Scale for Adult Patients-Nurse Assessment Short Form.
Control Group:
After hospital admission, participants will complete a Personal Information Form. On postoperative day 1, before the first mobilization, the Tampa Scale for Kinesiophobia will be administered. Following the baseline assessment, participants will receive the routine verbal mobilization education provided by the nurse. Immediately after the education, the Tampa Scale for Kinesiophobia will be administered again. Four hours before hospital discharge, participants will complete the Readiness for Hospital Discharge Scale-Patient Self-Assessment Form, and the nurse will complete the Readiness for Hospital Discharge Scale for Adult Patients-Nurse Assessment Short Form.
At the final stage of the study, all preoperative and postoperative data collected from the participants will be compiled, recorded, and analyzed.
Inclusion Criteria:
Patients will be included in the study if they meet the following criteria:
Age 18 years or older Undergoing total knee arthroplasty for the first time Able to read and write in Turkish No impairments that would prevent watching, hearing, or understanding the educational video No diagnosed psychiatric disorders and not using psychiatric medications that may affect the accuracy of responses No additional conditions affecting mobility other than knee arthroplasty No administration of narcotic analgesics within 30-60 minutes prior to mobilization Having access to a mobile phone capable of viewing the educational video during both the preoperative and postoperative periods.
The population of the study will consist of all patients undergoing total knee arthroplasty in the Orthopedics Clinic of a state hospital. The sample will include patients who meet the study eligibility criteria and agree to participate in the study. A total of 72 patients will participate in the study, with 36 patients assigned to the control group and 36 patients assigned to the intervention group. Written and verbal informed consent will be obtained from all patients prior to participation in the study.
Data will be analyzed using SPSS version 25.0 (Statistical Package for the Social Sciences).
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Total knee arthroplasty (TKA) is one of the most effective surgical treatments for patients with advanced knee osteoarthritis. Early postoperative mobilization is essential for reducing complications, improving functional recovery, increasing patient independence, and facilitating a safe hospital discharge. However, many patients experience kinesiophobia after surgery, which may negatively affect their participation in rehabilitation and delay recovery. Innovative educational approaches, including artificial intelligence (AI)-assisted education, may improve patients' understanding of postoperative mobilization and increase their confidence in performing recommended activities.
The purpose of this study is to evaluate the effect of AI-assisted mobilization education on kinesiophobia and readiness for hospital discharge in patients undergoing total knee arthroplasty.
This is a non-randomized controlled interventional study involving 72 adult patients scheduled to undergo primary total knee arthroplasty. Participants will be allocated to either the intervention group (n=36) or the control group (n=36). The control group will receive the routine perioperative education and standard nursing care provided by the orthopedic clinic. In addition to routine care, the intervention group will receive AI-assisted mobilization education designed to support postoperative recovery and encourage early mobilization.
Data will be collected using a Patient Information Form, the Tampa Scale for Kinesiophobia, the Readiness for Hospital Discharge Scale-Patient Self-Assessment Form, and the Readiness for Hospital Discharge Scale-Nurse Assessment Form for Adult Patients. Assessments will be performed on the first postoperative day and approximately four hours before hospital discharge.
The primary objective of the study is to determine whether AI-assisted mobilization education reduces kinesiophobia and improves patients' readiness for hospital discharge compared with routine care. The findings are expected to contribute to the development of evidence-based educational interventions that enhance postoperative recovery and discharge preparation for patients undergoing total knee arthroplasty.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Berru B Erseçkin
- Telefonní číslo: +90 543 507 48 87
- E-mail: berru038@hotmail.com
Studijní místa
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İzmit
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Kocaeli, İzmit, Turecko (Türkiye), 41900
- Nábor
- Seka Devlet Hastanesi
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Kontakt:
- Berru Erseçkin
- Telefonní číslo: +90 543 507 4887
- E-mail: berru038@hotmail.com
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Kontakt:
- Züleyha Şimşek Yaban
- Telefonní číslo: +90 505 228 0785
- E-mail: zuleyha.simsek@kocaeli.edu.tr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Willing to participate in the study voluntarily,
- Aged 18 years or older,
- Undergoing primary total knee arthroplasty for the first time,
- Able to read and write in Turkish,
- Having no visual, hearing, or cognitive impairment that would prevent watching, hearing, or understanding the educational video,
- Having no psychiatric disorder or use of psychiatric medication that could interfere with providing accurate responses to the study questionnaires, Having no other condition, apart from the indication for total knee arthroplasty, that affects mobility,
- Not having received narcotic analgesia within 30-60 minutes before mobilization,
- Having access to a mobile phone on which the educat
Exclusion Criteria:
- Patients who are immobile or have restricted mobility,
- Patients undergoing revision surgery or those who have undergone concomitant orthopedic surgery or orthopedic surgery within the previous month,
- Patients with impaired consciousness,
- Patients who decline to participate in the study,
- Patients with visual, hearing, or cognitive impairment,
- Patients who develop a postoperative complication resulting in restricted mobility,
- Patients with any condition that limits mobilization (e.g., amputation, paralysis, etc.)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: 1.Control Group - Standard Mobilization Education
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Experimentální: Intervention Group - AI-Assisted Video-Based Mobilization Education
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Participants in the intervention group will receive an artificial intelligence-assisted video-based mobilization education program designed to prepare them for postoperative mobilization after total knee arthroplasty.
The educational video will be delivered by a nurse on postoperative day 1 prior to the first mobilization.
The content of the video includes information and guidance on safe mobilization techniques following surgery.
Kinesiophobia levels will be assessed using the Tampa Scale for Kinesiophobia before and immediately after the intervention.
In addition, readiness for hospital discharge will be evaluated prior to discharge using the Readiness for Hospital Discharge Scale.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Effect of AI-Assisted Mobilization Education on Kinesiophobia Change in Kinesiophobia
Časové okno: Postoperative day1, immediately before and after mobilization education.
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Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK).
The TSK is a validated questionnaire used to measure fear of movement and reinjury.
Higher scores indicate greater levels of kinesiophobia.
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Postoperative day1, immediately before and after mobilization education.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Effect of AI-Assisted Mobilization Education on Readiness for Hospital Discharge Readiness for Hospital Discharge
Časové okno: Within 4 hours before hospital discharge.
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The effect of AI-assisted mobilization education on readiness for hospital discharge will be evaluated using the Readiness for Hospital Discharge Scale-Patient Self-Assessment Form.
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Within 4 hours before hospital discharge.
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Effect of AI-Assisted Mobilization Education on Readiness for hospital Discharge Readiness for hospital Discharge
Časové okno: Within 4 hours before hospital discharge
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The effect of AI-Assisted Mobilization Education on Readiness for hospital Discharge will be evaluated using the Readiness for Hospital Discharge Scale-Nurse Self- Assesment Form
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Within 4 hours before hospital discharge
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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