The Effect of Rehabilitative Nursing Care Practices on Frail Patients Undergoing Knee Arthroplasty and Their Caregivers
NCT ID: NCT07201454
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-10-01
2026-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Early Mobilization After Arthroplasty
NCT04858685
Mobile Application Based Care for Total Knee Prosthesis Patients
NCT06346717
The Effectiveness of Client-Centered Intervention inTotal Hip Arthroplasty
NCT06070220
Application of Rapid Rehabilitation Nursing in Perioperative Rehabilitation of Knee Arthroscopy
NCT04467359
Nursing Intervention for the Reduction of Anxiety During the Process of Primary Total Hip Arthroplasty Within the Optimized Recovery Program.
NCT05882227
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Method: This study will be conducted as a randomized controlled experimental study with 50 frail patients and their caregivers who underwent knee arthroplasty surgery at the orthopedic ward of Erzincan Mengücek Gazi Training and Research Hospital between October 2025 and June 2026. Patients and caregivers will be assigned to experimental (25) and control (25) groups using a simple randomization method. A mixed design, randomized controlled experimental, and phenomenological study is planned to determine the effects of this study on the feeling of entrapment and caregiver burden of caregivers and on patient satisfaction.
Data collection: The Descriptive Characteristics Form will be applied to the patients' primary caregivers and their relatives. Then, the Feelings of Entrapment Scale, the Zarit Burden of Care Scale, the Caregiver Satisfaction Assessment Index (CASI-TR) and the Patient Satisfaction Assessment Form According to Watson Recovery Processes will be applied to the patients. Then, after the recovery care procedures are completed, on the 4th postoperative day, the Feelings of Entrapment Scale, the Zarit Burden of Care Scale, the Caregiver Satisfaction Assessment Index (CASI-TR) and the Patient Satisfaction Assessment Form According to Watson Recovery Processes will be applied to the patients. Then, the questions in the semi-structured interview form will be asked and their answers will be transferred as is, without any comments. They will also be audio-recorded to prevent data loss and to ensure that the responses can be listened to again by the researcher later. The Feelings of Entrapment Scale, the Zarit Caregiver Burden Scale, and the Caregiver Satisfaction Assessment Index (CASI-TR) will be administered to the primary caregivers and patients in the control group on Day 4. The Patient Satisfaction Assessment Form will be administered to the patients based on Watson Improvement Processes.
Original Value: No studies have been found in the literature that evaluate the theoretical basis of caregiver care for frail patients undergoing knee arthroplasty surgery, their satisfaction with caregiving, the impact of feeling entrapment, or patient satisfaction. In this respect, the project has unique value and will contribute scientifically to national and international literature. If successful, it is expected to introduce holistic nursing care practices to the field regarding the care of frail patients undergoing knee arthroplasty surgery, which presents significant challenges for caregivers. In this respect, the project has unique value.
Expected Outcome: If the project is successful, it will reduce anxiety and caregiver burden in patients' relatives and increase patient-family interaction, contributing to improved patient care and economic efficiency.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental group
The study group will consist of patients over the age of 18 who underwent knee arthroplasty surgery at the Orthopedics and Traumatology Clinic of Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital, who have been hospitalized for at least four days postoperatively, and who have a score of ≥7 on the Edmonton Frailty Scale, as well as caregivers over the age of 18 who are the primary caregivers of these patients (both groups must meet criteria such as proficiency in Turkish and volunteering for the study). A total of 25 patients and 25 caregivers will participate in the experimental group.
nursing care
The first stage is the collection of quantitative data. Only quantitative data were collected from patients and caregivers in the experimental and control groups before the implementation of curative care practices based on human caring theory. The second stage includes curative care practices within the scope of the study for the experimental group. Patients and their relatives in the control group will receive routine care services provided at the clinics where the study was conducted, but no interventions will be implemented by the researchers. The third stage is the stage where patient satisfaction, caregiver burden, feelings of entrapment, and satisfaction with caregiving are assessed after the curative care practices. This stage is the final test of quantitative data and the collection of qualitative data. The fourth stage is the evaluation stage. In the final stage, data obtained from all stages will be compared, evaluated, and interpreted.
Control group
The study group will consist of patients over the age of 18 who underwent knee arthroplasty surgery at the Orthopedics and Traumatology Clinic of Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital, who have been hospitalized for at least four days postoperatively, and who have a score of ≥7 on the Edmonton Frailty Scale, as well as caregivers over the age of 18 who are the primary caregivers of these patients (both groups will meet criteria such as proficiency in Turkish and volunteering for the study). A total of 25 patients and 25 caregivers will participate in the control group.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
nursing care
The first stage is the collection of quantitative data. Only quantitative data were collected from patients and caregivers in the experimental and control groups before the implementation of curative care practices based on human caring theory. The second stage includes curative care practices within the scope of the study for the experimental group. Patients and their relatives in the control group will receive routine care services provided at the clinics where the study was conducted, but no interventions will be implemented by the researchers. The third stage is the stage where patient satisfaction, caregiver burden, feelings of entrapment, and satisfaction with caregiving are assessed after the curative care practices. This stage is the final test of quantitative data and the collection of qualitative data. The fourth stage is the evaluation stage. In the final stage, data obtained from all stages will be compared, evaluated, and interpreted.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Speak and understand Turkish
* Be over 18 years of age
* Have a patient they care for undergoing knee arthroplasty
* Be a caregiver for a frail patient who scores 7 or higher on the Edmonton Frailty Scale
* Provide primary care for the patient
* Voluntarily participate in the study
Exclusion Criteria
* Admission to the intensive care unit after surgery
* Re-surgery during the postoperative period
* Death of the patient during the study
* Voluntary withdrawal from the study or lack of communication
* Transfer of caregiving role to another person after the study begins
* Caregivers experiencing a physical or psychological health problem that would prevent them from continuing the study
* Caregivers refusing to continue the study or lack of communication
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ataturk University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
İlknaz Kara
PhD Student
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ataturk, Zubeyde Hanim St. No: 10, 24180 Erzincan Center/Erzincan, Erzincan, Erzincan 24180
Erzincan, Merkez, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Ilknaz_Doktara_Tezi
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.