Aile Merkezli Güçlendirme Modeline Dayalı Programın Total Diz Protezli Hasta ve Bakım Vericiler Üzerine Etkisi: Randomize Kontrollü Çalışma Protokolü

Yıl 2025, Cilt: 35 Sayı: 5, 839 - 854, 28.10.2025

Yasemin Şara , Fatma Taş Arslan , Şerife Kurşun Kural

Öz

ÖZ
Amaç: Total Diz Artroplastisi (TDA) geçiren bireylere ve bakım verenlerine verilen Aile Merkezli Güçlendirme Modeli (FCEM) programının bireylerin fizyolojik fonksiyon düzeyi, öz yeterlilik, taburcu olduktan sonra tekrar hastaneye yatış (takip süresi boyunca); bakım verenin bakım yükü, bakım verme yeterliliği ve stresle başa çıkma becerileri üzerindeki etkilerini değerlendiren çalışmanın içeriğinin ayrıntılarını sunmaktır.
Gereç ve Yöntem
Bu çalışma randomize kontrollü deneysel araştırma olarak tasarlanmıştır ve Clinical Trials’a NCT06402539 numara ile kaydedilmiştir. Çalışmaya müdahale ve kontrol grubu olmak üzere toplamda 62 hasta dahil edilecektir. Verilerin toplanmasında Sosyodemografik Özellikler Formu, Ameliyat sonrası komplikasyon gelişme formu, Barthel Günlük Yaşam Aktiviteleri Indeksi, Genel Öz Yeterlilik Ölçeği, Zarit Bakım Verme Yükü, Bakım Verme Yeterlilği ve Stresle Baş Etme Ölçeği ile toplanacaktır. Müdahale grubundaki hastalara AMGM göre yapılandırılmış kitapçıkla beraber 5 hafta boyunca 8 kere danışmanlık verilecektir. Kontrol grubundaki hastalar ise standart bakımlarını alıp; son izlem de (ameliyat sonrası 30.günden sonra) kitapçıktaki ameliyat sonrası 30.günden sonra yapılması gerekenler bölümü verilecektir.
Bulgular
Araştırma sonucunda elde edilen verilerin istatistiksel analizi, bilgisayar ortamında SPSS 29 paket programı kullanılarak hesaplanacaktır. Tanımlayıcı istatistikler için sayı, yüzde, ortalama ve standart sapma, grupların tanımlayıcı özellikler yönünden benzerliğinin/homojenliğinin karşılaştırılmasında ki-kare analizi kullanılacaktır. Elde edilen sonuçlar p<0,05 anlamlılık düzeyinde değerlendirilecektir.
Sonuç
Çalışma protokolümüz AMGM programının detaylarını sunarak bir sonraki araştırmalara rehberlik edecektir.

Anahtar Kelimeler

Aile Merkezli Bakım , Güçlendirme , Bakım Vericiler , Artroplasti , Diz , Hasta Sonuçları

Etik Beyan

Çalışmanın etik kurul onayı Selçuk Üniversitesi Hemşirelik Fakültesi Girişimsel Olmayan Klinik Araştırmalar Etik Kurulu'nun 2023/43 karar numarası ile alındı. Çalışmanın yürütüleceği hastaneden kurumsal izin alındı (583484/01.09.2023).

Destekleyen Kurum

Selçuk Üniversitesi

Proje Numarası

23112003

Teşekkür

Bu araştırmanın yürütülmesine destek olan Ortopedi ve Travmatoloji Anabilim Dalı Başkanı Prof. Dr. B. Kerem Aydın'a ve çalışmaya katılan tüm hasta ve bakım vericilere teşekkür etmek isteriz.

Effect of A Program Based on A Family-Centered Empowerment Model on Total Knee Arthroplasty Patients and Their Caregivers: A Randomized Controlled Trial Protocol

Öz

ABSTRACT
Background/Aims: The aim is to present the details of the content of the study evaluating the effects of the Family-Centered Empowerment Model (FCEM) program given to individuals who underwent Total Knee Arthroplasty (TKA) and their caregivers on the individuals' physiological function level, self-efficacy, post-discharge rehospitalization (during the follow-up period); the caregiver's care burden, caregiving competence, and stress coping.
Methods:This study was designed as a randomized controlled experimental study and was registered with ClinicalTrials under the number NCT06402539. A total of 62 patients will be included in the study, including the intervention and control groups. Data will be collected using the Sociodemographic Characteristics Form, Postoperative Complication Development Form, Barthel Daily Living Activities Index, General Self-Efficacy Scale, Zarit Caregiver Burden, Caregiver Competence, and Stress Coping Scale. Patients in the intervention group will receive counseling 8 times for 5 weeks with a booklet structured according to FCEM. Patients in the control group will receive their standard care; at the last follow-up (30th day after surgery), the section on what to do after 30th day after surgery in the booklet will be provided.
Results: The statistical analysis of the data obtained as a result of the research will be calculated using the SPSS 29 package program in a computer environment. For descriptive statistics, number, percentage, mean and standard deviation, chi-square analysis will be used to compare the similarity/homogeneity of the groups in terms of descriptive characteristics. The results obtained will be evaluated at the p<0.05 significance level.
Conclusion: Our study protocol will guide subsequent research by providing details of the FCEM program.

Anahtar Kelimeler

Family Centered Nursing , Empowerment , Caregivers , Arthroplasty , Knee , Patient Outcome.

Etik Beyan

The study's ethics committee approval was obtained from the Selçuk University Faculty of Nursing Non-Interventional Clinical Research Ethics Committee with the decision number 2023/43. Institutional permission was obtained from the hospital where the study would be conducted. (583484/01.09.2023).

Destekleyen Kurum

Selçuk University

Proje Numarası

23112003

Teşekkür

We would like to thank Prof. Dr. B. Kerem Aydın, Head of the Department of Orthopedics and Traumatology, for supporting the conduct of this research and all the patients and caregivers who participated in the study.

Kaynakça

• 1. Zhu S, Qu W, He C. Evaluation and management of knee osteoarthritis. J Evid Based Med. 2024;17:675-87.
• 2. Rajgopal A, Kumar S, Aggarwal K. Evaluating long term outcomes and survivorship of cruciate retaining and sacrificing knee replacements done for degenerative arthritis in patients under 55 years. Indian J Orthop. 2021;55:1180-5.
• 3. Niemeläinen M. Outcome of Contemporary Knee Arthroplasty: In terms of survivorship and patient reported outcome measures with special reference to patients less than 65 years of age,(Tampere University Dissertations). 2020.
• 4. Parker RJ. Evidence-based practice: caring for a patient undergoing total knee arthroplasty. Orthop Nurs. 2011;30:4-8.
• 5. Wainwright TW, Memtsoudis SG, Kehlet H. Fast-track hip and knee arthroplasty... how fast? Br J Anaesth. 2021;126:348-9.
• 6. Reinhard S, Given B, Petlick N, Bemis A. Supporting family caregivers in providing care. Patient safety and quality: An evidence-based handbook for nurses. US: Agency for Healthcare and Quality. 2008.
• 7. Bull MJ, Boaz L, Maadooliat M, et al. Preparing family caregivers to recognize delirium symptoms in older adults after elective hip or knee arthroplasty. J Am Geriatr Soc. 2017;65:e13-e7.
• 8. Churchill L, Pollock M, Lebedeva Y, et al. Optimizing outpatient total hip arthroplasty: perspectives of key stakeholders. Can J Surg. 2018;61:370.
• 9. Paxton EW, Inacio MC, Singh JA, et al. Are there modifiable risk factors for hospital readmission after total hip arthroplasty in a US healthcare system? CORR ®. 2015;473:3446-55.
• 10. Bamari F, Madarshahian F, Barzgar B. Reviews burden of caring caregivers of patients with type II diabetes referred to diabetes clinic in the city of Zabol. J Diabetes Nurs. 2016;4:59-67.
• 11. Mousaei FM, Mirhosseini S, Mafi MH, Günaydın N, Zendehtalab HR. Effect of support based on family centered empowerment model on care burden in family caregivers of patients with multiple sclerosis. Front Public Health. 2023;11:1115311.
• 12. Abedini F, Zareiyan A, Alhani F. The Effects of the Family-centered Empowerment Model on Self-efficacy and Self-esteem among the Family Caregivers of Patients with Prosthetic Heart Valve: A Controlled Clinical Trial. Nurs Midwifery Stud. 2020;9 : 61-67.
• 13. Alhani F, Asghari-Jafarabadi M, Norouzadeh R, et al. The effect of family-centered empowerment model on the quality of life of adults with chronic diseases: An updated systematic review and meta-analysis. J Affect Disord. 2022;316:140-7.
• 14. Bashar FR, Salesi M, Alhani F. A review of 15 years application the family centered empowerment model on the consequences of acute and chronic Diseases. J of Mil Med. 2019;21:325-41.
• 15. Liang H, Hou J, Xiong J. Effect of Family-Centered Empowerment Model in Home Care of Older Adult Patients After Total Knee Arthroplasty. J Community Health Nurs. 2024;41:162-74.
• 16. Martínez-Mesa J, González-Chica DA, Bastos JL, Bonamigo RR, Duquia RP. Sample size: how many participants do I need in my research? An Bras Dermatol. 2014;89:609-15.
• 17. Timmins F. Nursing research generating and assessing evidence for nursing practice. Nurse Educ Pract. 2013;13:e29.
• 18. Mora‐Traverso M, Molina‐Garcia P, Prieto‐Moreno R, et al. An m‐Health telerehabilitation and health education program on physical performance in patients with hip fracture and their family caregivers: Study protocol for the ActiveHip+ randomized controlled trial. Res Nurs Health. 2022;45:287-99.
• 19. O’Neil E, Ngan J, Miller WC, Mohammadi S. Family Caregivers’ Experiences and Education When Caring for Individuals after Joint Arthroplasty. Phys Occup Ther Geriatr. 2023;41:483-501.
• 20. Pua Y-H, Seah FJ-T, Poon CL-L, et al. Age-and sex-based recovery curves to track functional outcomes in older adults with total knee arthroplasty. Age and Ageing. 2018;47:144-8.
• 21. Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”: a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12:189-98.
• 22. Güngen C, Ertan T, Eker E, Yaşar R, Engin F. Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population. Turk Psikiyatri Derg. 2002;13:273-81.
• 23. Mansurov JS, Tkachenko AN, Saiganov SA, et al. Negative Effects of Knee Replacement. J Exp Clin Surgery. 2022;15:354-61.
• 24. Atkinson HDE. The negatives of knee replacement surgery: complications and the dissatisfied patient. Orthop Trauma. 2017;31:25-33.
• 25. Nakano N, Shoman H, Olavarria F, et al. Why are patients dissatisfied following a total knee replacement? A systematic review. Int J Orthop. 2020;44:1971-2007.
• 26. Mahoney FI, Barthel DW. Functional evaluation: the Barthel Index: a simple index of independence useful in scoring improvement in the rehabilitation of the chronically ill. Md Med. 1965.
• 27. Küçükdeveci AA, Yavuzer G, Tennant A, et al. Adaptation of the modified Barthel Index for use in physical medicine and rehabilitation in Turkey. Scand J Rehabil Med. 2000;32:87-92.
• 28. Schwarzer, Ralf; Jerusalem, Matthias. Generalized self-efficacy scale. J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user’s portfolio. Causal and control beliefs, 1995, 35.37: 82-003.
• 29. Aypay A. Genel öz yeterlik ölçeği'nin (GÖYÖ) Türkçe'ye uyarlama çalışması. INUEFD. 2010;11:113-32.
• 30. Back-Peterson ZSRK. J. Relatives of the ımpaired elderly: correlates of burden. Gerontologist. 1980;20:649-55.
• 31. İnci F, Erdem M. Bakim verme yükü ölçeği’nin türkçe'ye uyarlanmasi geçerlilik ve güvenilirliği. J nursology. 2006;11:85-95.
• 32. Pearlin LI, Mullan JT, Semple SJ, Skaff MM. Caregiving and the stress process: An overview of concepts and their measures. Gerontologist. 1990;30:583-94.
• 33. Avci YD, Gözüm S. Bakım Verme Yeterliliği Ölçeği’nin Türkçe Uyarlaması ve Psikometrik Olarak Test Edilmesi. Bezmialem Science, 2022;10(1):81-7.
• 34. Moos R. Life stressors and social resources inventory: Coping responses inventory. Palo Alto, CA: Center for Health Care Evaluation, Department of Psychiatry and Behavioral Sciences, Stanfird University. 1993.
• 35. Ballı AİK, Kılıç KC. Stresle Başa Çikma Yöntemleri Ölçeğinin Türkçe’ye Uyarlanmasi: Geçerlilik Ve Güvenirlik Çalişmasi. ÇÜSBED. 2016;25:273-86.
• 36. Schulz K, Grimes DA. Essential concepts in clinical research: Randomised controlled trials and observational epidemiology: Elsevier Health Sciences; 2018.
• 37. Boutron I, Altman DG, Moher D, et al. CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med. 2017;167:40-7.
• 38. Jull A, Aye PS. Endorsement of the CONSORT guidelines, trial registration, and the quality of reporting randomised controlled trials in leading nursing journals: a cross-sectional analysis. Int J Nurs Stud. 2015;52:1071-9.
• 39. Butcher NJ, Monsour A, Mew EJ, et al. Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension. JAMA. 2022;328:2252-64.
• 40. Copanitsanou P, Sourtzi P, Cano S, et al. Empowering education of arthroplasty patients' significant others in three Southern European countries. Int J Older People Nurs. 2018;13:e12193.
• 41. Jafari-Diziche S, Izadi-Avanji F-S, Atoof F, Derakhshandeh S-M, Azizi-Fini I. Effect of Family-Centered Empowerment Model on the Care Burden of the Caregivers of Older Adults with Heart Failure. JCCNC. 2021;7.
• 42. Wang Z, Yu S, Liu Y, et al. Effectiveness of family centred interventions for family caregivers: A systematic review and meta‐analysis of randomized controlled trials. Journal of Clinical Nursing. 2024;33:1958-75.