| Registry | NCT07201454 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, supportive care |
| Enrollment | 100 (Actual) |
| Sponsor | Ataturk University (Other) |
| Conditions | Knee Arthroplasty |
| Interventions | nursing care (Behavioral) |
| Dates | start 2025-12-01, primary completion 2026-06-30, completion 2026-08-24, first posted 2025-10-01, last updated 2026-09-08 |
| Locations | 1 site in Turkey (Türkiye) |
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All trials for Knee Arthroplasty All trials of nursing care
This study was designed to holistically examine the effects of curative nursing care practices based on human caring theory on frail patients and their caregivers undergoing knee arthroplasty.
Objective: This study was designed to holistically examine the effects of healing nursing care practices based on Watson's Theory of Human Caring on the feelings of entrapment, caregiver burden, and caregiving satisfaction of caregivers of frail patients undergoing knee arthroplasty, as well as their impact on patient satisfaction.
Method: This study was conducted as an embedded mixed-methods design \[QUAN(qual)\], combining a randomized controlled, pre-test/post-test experimental method (quantitative strand) with a phenomenological design based on Heidegger's hermeneutic approach (qualitative strand), with 50 frail patients (Edmonton Frailty Scale score ≥7) and their 50 primary caregivers who underwent/provided care for knee arthroplasty surgery at the Orthopedics and Traumatology Ward I-II of Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital between December 2025 and June 2026 (confirm exact end date - see note below). Patients and caregivers were assigned to experimental (n=25) and control (n=25) groups using simple randomization (1:1 allocation via www.randomizer.org). Blinding was not feasible, as data collection and intervention delivery were carried out by a single researcher and participants were aware of their group assignment.
Data collection: The Descriptive Characteristics Form was applied to patients and their primary caregivers before surgery. At the same time-point, the Feelings of Entrapment Scale, the clinic-adapted Zarit Caregiver Burden Scale, and the Caregiver Satisfaction Assessment Index (CASI-TR) were applied to the caregivers, and the Patient Satisfaction Assessment Form Based on Watson's Theory of Human Caring (first 5 items) was applied to the patients. Patients and caregivers in the experimental group then received structured nursing care based on the 5th, 7th, and 9th Caritas Processes of Watson's Theory of Human Caring, delivered from hospital admission through postoperative Day 4; the control group received routine ward care with no researcher intervention. On postoperative Day 4, the same instruments (Feelings of Entrapment Scale, Zarit Caregiver Burden Scale, and CASI-TR for caregivers; Patient Satisfaction Assessment Form for patients) were re-administered to both groups. On the same day, semi-structured interviews were conducted individually with all patients (n=25) and caregivers (n=25) in the experimental group only; responses were transcribed verbatim without researcher commentary and, with participant consent, audio-recorded to prevent data loss and allow later review.
Original Value: No prior studies were found in the literature evaluating the theoretical basis of caregiver care for frail patients undergoing knee arthroplasty, caregiving satisfaction, feelings of entrapment, or patient satisfaction in this population. The study therefore has original value and contributes to national and international literature. Its findings introduce a holistic, theory-based (Watson's Theory of Human Caring) nursing care model for frail patients undergoing knee arthroplasty and their caregivers.
Expected Outcome: The findings demonstrated that the intervention reduced caregivers' feelings of entrapment and caregiver burden while increasing caregiving satisfaction, and significantly increased patient satisfaction compared with routine care, supporting improved patient-family interaction and more effective, theory-based nursing care.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Experimental group | Experimental | Behavioral: nursing care | 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 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. |
| Control group | No intervention | 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 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. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: Patient Inclusion Criteria: * Speaking and understanding Turkish * Being over 18 years of age * Scoring 7 or higher on the Edmonton Vulnerability Scale * Voluntary participation in the study * Caregivers meeting the inclusion criteria * Undergoing knee arthroplasty surgery for the first time Caregiver Inclusion Criteria: * Literate * Speaks and understands Turkish * Over 18 years of age * Cares for a patient undergoing knee arthroplasty * Is the primary caregiver of a frail patient scoring 7 or higher on the Edmonton Frailty Scale * Provides primary care for the patient * Has no physical or psychological health problem that would prevent providing care * Voluntarily participates in the study Exclusion Criteria: Patient-related exclusion criteria: * Developing serious surgical complications (e.g., embolism, etc.) after knee arthroplasty * 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 Caregiver-related exclusion criteria: * Transfer of the caregiving role to another person after the study begins * Caregiver experiencing a physical or psychological health problem preventing continuation * Caregiver refusing to continue the study or lack of communication
| Facility | City | Country | Status |
|---|---|---|---|
| Ataturk, Zubeyde Hanim St. No: 10, 24180 Erzincan Center/Erzincan, Erzincan, Erzincan 24180 | Erzincan, Merkez | Turkey (Türkiye) |