- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07264712
Wpływ edukacji pacjentów w zakresie opieki nad ranami na wiedzę o opiece nad ranami, poczucie własnej skuteczności w samoopiece oraz jakość powrotu do zdrowia
Wpływ edukacji w zakresie pielęgnacji ran przeprowadzonej u pacjentów poddawanych operacji protezowania na wiedzę dotyczącą pielęgnacji ran, samoocenę samoopieki oraz jakość rekonwalescencji
This study will be conducted as a randomized controlled trial to determine the impact of artificial intelligence-assisted wound care training provided to patients undergoing prosthetic surgery on their wound care knowledge, quality of healing, and self-care self-efficacy. It was planned to include 22 individuals in the experimental group and 22 in the control group. However, considering the potential for data loss, the study was planned to be completed with a total of 50 individuals: 25 in the experimental group and 25 in the control group. Patient Identification Form, Patient Follow-up Form, Knowledge Level Questionnaire, Self-Care Self-Efficacy Scale and Quality of Recovery (QoR-15) Scale were used to collect data.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
It is crucial to educate patients and their caregivers who have undergone prosthetic surgeries such as TKA and THA about home care before discharge. Therefore, this study will be conducted as a randomized controlled trial to determine the impact of artificial intelligence-assisted wound care training provided to patients undergoing prosthetic surgery on their wound care knowledge, quality of healing, and self-care self-efficacy. The study population will consist of patients hospitalized in the Orthopedics and Traumatology Department of Erciyes University Health Application and Research Center after total hip and knee replacement surgeries, and the sample will consist of patients who meet the inclusion criteria. With 80% power, an effect size of 0.776, and a 95% confidence interval, it was planned to include 22 individuals in the experimental group and 22 in the control group. However, considering the potential for data loss, the study was planned to be completed with a total of 50 individuals: 25 in the experimental group and 25 in the control group. Patient Identification Form, Patient Follow-up Form, Knowledge Level Questionnaire, Self-Care Self-Efficacy Scale and Quality of Recovery (QoR-15) Scale were used to collect data.
Research data will be collected by the researcher between October 2025 and March 2026. The firstly, begins with the patients' hospitalization prior to surgery, and the assignment to either the experimental or control groups will be determined.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Melikgazi
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Kayseri, Melikgazi, Turcja (Türkiye)
- Erciyes University
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Kayseri, Melikgazi, Turcja (Türkiye)
- Health training and research hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Those undergoing total hip or knee replacement surgery
- Those who volunteer to participate in the study
- Those over 18 years of age
- Those who have no communication problems (language, hearing impairment, etc.)
Exclusion Criteria:
- Patients who have developed a surgical site infection
- Illiterate
- Unable to self-care
- Previously had prosthetic surgery will not be included.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Education group
The purpose of the study will be explained to the individuals in the experimental group using a face-to-face interview technique, and a patient introduction form will be administered by the researcher one day before surgery. The researcher will then provide patients with visual and verbal wound care training using the "Surgical Patient Wound Care Guide," and the educational materials will be provided. To assess the effectiveness of the training, a Knowledge Level Survey consisting of 10 true/false questions will be administered to patients on the third postoperative day. Two weeks after surgery, the Patient Follow-up Form, Self-Care Self-Efficacy Scale, and Quality of Healing Scale will be completed by phone. |
The purpose of the study will be explained to the individuals in the experimental group using a face-to-face interview technique, and a patient introduction form will be administered by the researcher one day before surgery. The researcher will then provide patients with visual and verbal wound care training using the "Surgical Patient Wound Care Guide," and the educational materials will be provided. To assess the effectiveness of the training, a Knowledge Level Survey consisting of 10 true/false questions will be administered to patients on the third postoperative day. Two weeks after surgery, the Patient Follow-up Form, Self-Care Self-Efficacy Scale, and Quality of Healing Scale will be completed by phone. |
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Brak interwencji: Control Group
The purpose of the study will be explained to the control group members, and a patient introduction form will be administered by the researcher using a face-to-face interview technique one day before surgery. On the third postoperative day, patients will be administered a Knowledge Level Questionnaire consisting of 10 true/false questions. Two weeks after surgery, the patient follow-up form, the Self-Care Self-Efficacy Scale, and the Quality of Recovery Scale will be completed by phone. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Knowledge Level
Ramy czasowe: postoperative day 3
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The researcher-created knowledge survey includes 10 true/false questions aimed at measuring the effectiveness of Surgical Patient Wound Care Education provided to patients. Each question will be evaluated out of 10. The lowest possible score is 0, and the highest is 100. Higher scores indicate higher knowledge levels. Expert opinions will be obtained from three faculty members with expertise in the field to assess the adequacy of the survey's content and scope. |
postoperative day 3
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Self-Care Self-Efficacy
Ramy czasowe: 15th day after surgery
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The scale originally developed by Yu et al. to determine individuals' self-care self-efficacy levels was modified by Chica-Pérez et al. to assess self-care self-efficacy in older adults with chronic multimorbidity. The scale was designed as a 5-point Likert-type instrument ranging from "1 = I do not trust myself" to "5 = I trust myself a lot." It consists of 10 items in total. In their study, Chica-Pérez et al. reported Cronbach's alpha coefficients as 0.713 for the subscale "Self-Efficacy in Clinical Knowledge-Based Self-Care Behaviors," 0.822 for "Self-Efficacy in Self-Care," 0.881 for "Self-Efficacy in Monitoring Self-Care," and 0.878 for "Self-Efficacy in Self-Care Management." Chica-Pérez et al. stated that the minimum possible score is 10 and the maximum is 50, with higher scores indicating higher levels of self-efficacy in self-care. |
15th day after surgery
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Quality of Recovery
Ramy czasowe: 15th day after surgery
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The Quality of Recovery-15 (QoR-15) is a brief postoperative recovery scale developed and validated by Stark et al. in 2013. It is a shortened version of the QoR-40 scale. It is easier to use because it is shorter and can be completed in a shorter time. Like the QoR-40, it contains 15 questions that assess the patient's pain, physical comfort, physical independence, psychological support, and emotional state. The test results in a score between 0 and 150, with a higher score indicating better recovery quality. With the latest update, the minimal clinically important difference, that is, the lowest difference indicating a meaningful change, is 6 for the QoR-15. |
15th day after surgery
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Yeliz SÜRME, ASSOCIATE, TC Erciyes University
Publikacje i pomocne linki
Publikacje ogólne
- Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.
- Yu DS, De Maria M, Barbaranelli C, Vellone E, Matarese M, Ausili D, Rejane RE, Osokpo OH, Riegel B. Cross-cultural applicability of the Self-Care Self-Efficacy Scale in a multi-national study. J Adv Nurs. 2021 Feb;77(2):681-692. doi: 10.1111/jan.14617. Epub 2020 Dec 9.
- Yıldız GN. Öz bakım öz yeterlilik ölçeği'nin Türkçe geçerlik güvenirliğinin sağlanması: Metodolojik bir araştırma. Turkiye Klinikleri J Nurs Sci, 2025;17(1), 174-183. https://doi.org/10.5336/nurses.2024-105063
- Chica-Perez A, Dobarrio-Sanz I, Correa-Casado M, Fernandez-Sola C, Ruiz-Fernandez MD, Hernandez-Padilla JM. Spanish version of the self-care self-efficacy scale: A validation study in community-dwelling older adults with chronic multimorbidity. Geriatr Nurs. 2023 Sep-Oct;53:181-190. doi: 10.1016/j.gerinurse.2023.07.016. Epub 2023 Aug 2.
- Ismail EA, Elshafie MA. Patient-reported outcomes after femoral nerve block versus periarticular injections in patients undergoing total knee arthroplasty: A randomized controlled study. Journal of Cleaner Production, 2021;277(12):123958 https://doi.org/10.1016/j.jclepro.2020.123958
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 2025/419
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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