Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07201454
Enrollment
100
Registered
2025-10-01
Start date
2025-12-01
Completion date
2026-08-24
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthroplasty

Keywords

knee arthroplasty, fragile patient, care burden, feeling stuck, caregiver, human care theory

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALnursing 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.

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

The study will be conducted at Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital. The hospital has 510 beds; the study will be conducted in the 42-bed Orthopedics and Traumatology Wards I and II.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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 4.4 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 4.4 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 4.4 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 4.4 days before and 4 days after application; supplementary open-ended follow-up by telephone with patients on post-discharge Day 7

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026