Clinical trial NCT07015879: The Effect of Continuous Care Counseling Based on the Roy Adaptation Model on Comfort and Quality of Life in Patients Undergoing Total Knee Arthroplasty
Official title: Evaluation of the Effect of Continuous Care Counseling Based on Roy's Adaptation Model on Comfort and Quality of Life in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Cyprus International University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Osteoarthritis is a chronic joint disease that affects millions of people worldwide and is particularly prevalent among the elderly population. Knee osteoarthritis leads to significant problems such as severe pain, restricted mobility, and loss of independence, thereby negatively impacting quality of life. In advanced stages of knee osteoarthritis, total knee arthroplasty (TKA) is a commonly preferred surgical method to reduce pain and loss of function. However, in the postoperative period following TKA, patients may experience multidimensional problems such as pain, sleep disturbances, psychological stress, anxiety, and difficulties in daily living activities.

In modern nursing practice, the management of these problems experienced by patients before and after surgery and the improvement of their quality of life are of great importance. Roy's Adaptation Model is a theoretical framework frequently utilized in nursing that supports individuals in adapting to environmental changes and stressors. This model advocates for a holistic assessment of patients in terms of their physiological, psychological, social, and role functions, and for the structuring of care plans accordingly.

This study aims to evaluate the effect of continuous care counseling based on Roy's Adaptation Model on the comfort and quality of life of patients undergoing total knee arthroplasty. In the research, specially designed training and counseling services were provided to patients who underwent surgery, and the effects of these services on pain, anxiety, sleep quality, and daily living activities were evaluated using both quantitative and qualitative methods. Within the scope of the study, patients in the intervention group received continuous care counseling and video-supported education based on the Roy Adaptation Model, while the control group received standard care. Data were collected and analyzed using quality of life and comfort scales.

The findings of the study indicate that continuous care counseling based on Roy's Adaptation Model may be effective in improving postoperative comfort and quality of life in patients undergoing total knee arthroplasty. These results may contribute to the improvement of postoperative care and the development of patient-centered care practices for both patients and healthcare professionals.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Undergoing emergency surgical intervention Readmission for revision surgery

Primary outcomes:
measure: Overall Comfort Level
timeFrame: Preoperative (5 days before surgery), postoperative 2nd day, and at the 1st and 3rd months after discharge
Secondary outcomes:
measure: Overall Quality of Life
timeFrame: Preoperative (5 days before surgery), postoperative 2nd day, and at the 1st and 3rd months after discharge
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Cyprus International University
state: Lefkosa
Study officials:
affiliation: Cyprus International University
name: Burcu Dikmen, PhD
role: PRINCIPAL_INVESTIGATOR
References: