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

NCT07201454 | Completed DMC

• 1 other identifier: Ilknaz_Doktara_Tezi
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthroplasty

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Behavioral: nursing care

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.

Interventions

nursing care BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Speaking and understanding Turkish
• Being over 18 years of age
• Scoring 7 or higher on the Edmonton Vulnerability Scale
• Voluntary participation in the study
• Undergoing knee arthroplasty surgery for the first time
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

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

Erzincan, Merkez, 24000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Caregiver Burden

Interventions

Nursing Care

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: October 1, 2025
• Study Start: December 1, 2025
• Primary Completion: June 30, 2026
• Study Completion: August 24, 2026
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)