The Effect of Rehabilitative Nursing Care Practices on Frail Patients Undergoing Knee Arthroplasty and Their Caregivers

NCT07201454 | Not Yet Recruiting DMC

• 1 other identifier: Ilknaz_Doktara_Tezi
• Study Type: interventional
• Target: 50
• 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)

• The effect of healing care on caregiver entrapment will be measured with the Feeling of Entrapment Scale, preoperatively and on the 4th postoperative day. Outcome is the change in total score.

  4 days before and 4 days after application

• The effect of therapeutic care on caregiver burden will be measured with the Zarit Caregiver Burden Scale (0-88), preoperatively and on the 4th postoperative day. Outcome is the change in total score.

  4 days before and 4 days after application

• The effect of healing care on caregiver satisfaction will be measured with the Caregiver Satisfaction Index (1-5), preoperatively and on the 4th postoperative day. Outcome is the change in satisfaction score.

  4 days before and 4 days after application

• The effect of therapeutic care on patient satisfaction will be measured with the Patient Satisfaction Form based on Watson's Healing Processes (0-100), preoperatively and on the 4th postoperative day. Outcome is score change.

  4 days before and 4 days after application

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 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.

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 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.

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:

• Literate
• 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

You may not qualify if:

• Developing serious surgical complications (e.g., infection, embolism, prosthesis rejection, 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 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

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

Central Study Contacts

Ilknaz K KARA

CONTACT

5325272400; ilknazkara_166@hotmail.com

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 between October 2025 and June 2026. The hospital has 510 beds and is planned to be conducted in 40-bed orthopedic wards I and II.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: October 1, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)