A Holistic Evaluation of the Effects of Healing Nursing Care Interventions on Frail Patient Undergoing Knee Arthroplasty and Their Caregivers

N/ACompletedNCT07201454

Ataturk University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

100

Conditions

Knee Arthroplasty

Interventions

nursing careBEHAVIORAL

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

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ataturk, Zubeyde Hanim St. No: 10, 24180 Erzincan Center/Erzincan, Erzincan, Erzincan 24180

Erzincan, Merkez, Turkey (Türkiye)

Outcomes

Primary Outcomes

Change in caregiver feelings of entrapment (Feelings of Entrapment Scale, 4 items, 5-point Likert, score range 0-16; higher=greater entrapment), measured preop and on postop Day 4.

Time frame: 4 days before and 4 days after application; supplementary open-ended follow-up by telephone with caregivers on post-discharge Day 7

Change in caregiver burden (clinic-adapted Zarit Caregiver Burden Scale, 18 items, score range 0-72; higher=greater burden), measured preop and on postop Day 4.

Time frame: 4 days before and 4 days after application; supplementary open-ended follow-up by telephone with caregivers on post-discharge Day 7

Change in caregiver satisfaction (Caregiver Satisfaction Assessment Index-Turkish version, CASI-TR, 30 items; higher=greater satisfaction), measured preop and on postop Day 4.

Time frame: 4 days before and 4 days after application; supplementary open-ended follow-up by telephone with caregivers on post-discharge Day 7

Change in patient satisfaction (Watson Patient Satisfaction Form, 5 items, 7-point Likert, range 5-35; higher=greater satisfaction), measured preop and on postop Day 4.

Time frame: 4 days before and 4 days after application; supplementary open-ended follow-up by telephone with patients on post-discharge Day 7

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.