The Effect of Continuous Care Counseling Based on the Roy Adaptation Model on Comfort and Quality of Life in Patients Undergoing Total Knee Arthroplasty

NCT07015879 | Completed

• 1 other identifier: TDP-RAM-
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis is a common joint disease that leads to problems such as pain, restricted mobility, and decreased quality of life in the knee joint, especially among elderly individuals. In advanced-stage knee osteoarthritis, total knee arthroplasty (TKA) is performed to reduce pain and loss of function. However, in the postoperative period, patients may encounter various problems such as pain, sleep disturbances, anxiety, and difficulties in daily living activities. This study investigates how continuous care counseling based on Roy's Adaptation Model affects the comfort and quality of life of patients undergoing total knee arthroplasty. Roy's Adaptation Model is a widely used approach in nursing that supports individuals in adapting to changes they experience. Counseling and education provided in line with this model aim to help patients cope with the physical and psychological problems they face before and after surgery. In the study, specially designed training and counseling services were offered to patients who underwent surgery, and the effects of these services on pain, anxiety, sleep quality, and daily living activities were evaluated. The results of the research indicate that continuous care counseling based on Roy's Adaptation Model may be effective in improving patients' postoperative comfort and quality of life. These findings may contribute to the improvement of postoperative care for both patients and healthcare professionals.

Conditions

Osteoarthritis; Care Model; Quality of Life; Nursing Interventions; Knee

Keywords

Knee osteoarthritis; Total knee arthroplasty; Roy Adaptation Model; Continuous care; Comfort; Quality of life; Nursing; Postoperative care; Patient education

Outcome Measures

Primary Outcomes (1)

• Overall Comfort Level

  Patients' overall comfort levels will be assessed using the "General Comfort Questionnaire Short Form" 5 days before surgery, on the 2nd day after surgery, and at the 1st and 3rd months after discharge.

  Preoperative (5 days before surgery), postoperative 2nd day, and at the 1st and 3rd months after discharge

Secondary Outcomes (1)

• Overall Quality of Life

  Preoperative (5 days before surgery), postoperative 2nd day, and at the 1st and 3rd months after discharge

Study Arms (2)

Continuous Care Counseling Based on the Roy Adaptation Model

EXPERIMENTAL

Patients in the experimental group will receive video-supported education with verbal explanation in the clinic five days before surgery; the session will be repeated one day before surgery to assess patient comprehension. The instructional video will remain accessible to the patient, and home-care precautions will be reviewed at discharge. Overall comfort and quality of life will be measured face-to-face both before and after surgery, and by telephone at the first and third months following discharge. Adherence to watching the video, performing prescribed exercises, and any postoperative complications will also be monitored.

Behavioral: Continuous Care Counseling Based on the Roy Adaptation Model

Control Group

NO INTERVENTION

Patients will receive the clinic's routine treatment and nursing care.

Interventions

Continuous Care Counseling Based on the Roy Adaptation Model BEHAVIORAL

Patients in the control group will receive the clinic's routine treatment and nursing care. This care includes preoperative and postoperative information, prevention of leg flexion, monitoring of vital signs, pain management, discharge education, and discharge of patients without complications three days after surgery. In addition, patients' overall comfort and quality of life will be assessed face-to-face five days before surgery and on the second postoperative day, and by telephone at the first and third months after discharge.

Continuous Care Counseling Based on the Roy Adaptation Model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provided written and verbal consent to participate in the study Aged 18 years or older Conscious, oriented, and cooperative Able to speak and understand Turkish Has the ability to speak, hear, and see Has no diagnosed psychiatric illness Has no known cancer diagnosis Undergoing elective surgical intervention Undergoing total knee arthroplasty (TKA) for the first time Undergoing unilateral TKA

You may not qualify if:

• Undergoing emergency surgical intervention Readmission for revision surgery

Sponsors & Collaborators

• Cyprus International University: lead

Study Sites (1)

Cyprus International University

Mersin, Lefkosa, 99040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Burcu Dikmen, PhD

  Cyprus International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is an open-label study. Due to the nature of continuous care counseling, it is not possible for participants and care providers to be unaware of the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Model Details: Participants were randomly assigned to either the intervention group, which received continuous care counseling based on the Roy Adaptation Model, or the control group, which received standard postoperative care. Data were collected preoperatively, on the second postoperative day, and at the first and third months after discharge.

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: June 23, 2024
• Primary Completion: November 19, 2024
• Study Completion: March 14, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)