OsteoarthritisRAM-TKANCT07015879
The Effect of Continuous Care Counseling Based on the Roy Adaptation Model on Comfort and Quality of Life in Patients Undergoing Total Knee Arthroplasty
A study testing Continuous Care Counseling Based on the Roy Adaptation Model in people with Osteoarthritis and Care Model, run by Cyprus International University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Care Model, Quality of Life
- What is being tested?
- Continuous Care Counseling Based on the Roy Adaptation Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Mar 2025to 14 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Able to speak, hear, and see
- No diagnosed psychiatric illness
Show all 10Show fewer
- No known cancer diagnosis
- Undergoing elective surgery
- Undergoing total knee arthroplasty (TKA) for the first time
- Undergoing unilateral total knee arthroplasty (TKA)
Who cannot join
- Undergoing emergency surgery
- Readmitted for revision surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cyprus International University
Mersin, Lefkosa, 99040
About this study
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
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 provided to patients undergoing surgery, and the effects of these interventions on comfort and quality of life were evaluated. The study aims to contribute to the enhancement of postoperative care practices and patient-centered nursing interventions for individuals undergoing total knee arthroplasty.
Read the 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, self-concept, role function, and interdependence modes, and for structuring nursing care plans accordingly.
This randomized controlled trial 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. Patients in the intervention group receive continuous care counseling and video-supported education based on the Roy Adaptation Model, while patients in the control group receive standard clinic care. Data are collected preoperatively, on the second postoperative day, and at the first and third months after discharge using standardized comfort and quality of life scales. The study aims to provide evidence on the effectiveness of model-based continuous nursing care in improving postoperative recovery and patient outcomes.
- Conditions
- Osteoarthritis, Care Model, Quality of Life, Nursing Interventions, Knee
- Being tested
- Continuous Care Counseling Based on the Roy Adaptation Model
- Keywords
- Knee osteoarthritis, Total knee arthroplasty, Roy Adaptation Model, Continuous care, Comfort, Quality of life, Nursing, Postoperative care, Patient education
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Care Counseling Based on the Roy Adaptation ModelBehavioural
Patients in the experimental group will receive video-supported education with verbal explanation in the clinic five days before surgery. The education will be repeated one day before surgery to assess the patient's understanding, and any gaps in knowledge will be addressed. On postoperative day 2, patients will receive practical education related to total knee arthroplasty. At discharge, patients will be provided with the educational video and instructed about home-care precautions. Overall comfort and quality of life will be assessed face-to-face five days before surgery and on postoperative day 2, and by telephone at the first and third months after discharge. During the telephone follow-ups, adherence to viewing the video and performing the prescribed exercises, as well as any postoperative complications, will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| 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 education will be repeated one day before surgery to assess the patient's understanding, and any gaps in knowledge will be addressed. On postoperative day 2, patients will receive practical education related to total knee arthroplasty. At discharge, patients will be provided with the educational video and instructed about home-care precautions. Overall comfort and quality of life will be assessed face-to-face five days before surgery and on postoperative day 2, and by telephone at the first and third months after discharge. During the telephone follow-ups, adherence to viewing the video and performing the prescribed exercises, as well as any postoperative complications, will be assessed. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Comfort Level Measured by the General Comfort Questionnaire Short Form
Patients' overall comfort will be assessed using the 28-item General Comfort Questionnaire Short Form. Items are rated from 1 to 6, and negatively worded items are reverse-coded. The total item score is divided by 28 to calculate a mean score ranging from 1 to 6. Higher scores indicate greater comfort.
Measured: Preoperative (5 days before surgery), postoperative 2nd day, and at the 1st and 3rd months after discharge
Secondary outcomes (1)
Overall Quality of Life Measured by the EuroQol 5-Dimension Questionnaire (EQ-5D) Index and Visual Analog Scale (VAS)
Patients' quality of life will be assessed using the EuroQol 5-Dimension Questionnaire (EQ-5D). The EQ-5D index score ranges from -0.59 to 1, where higher scores indicate better quality of life. The EQ-5D Visual Analog Scale (VAS) ranges from 0 (worst imaginable health) to 100 (best imaginable health), where higher scores indicate better quality of life.
Measured: Preoperative (5 days before surgery), postoperative 2nd day, and at the 1st and 3rd months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start23 Mar 2025
- Primary completion19 Sep 2025
- Study completion14 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyprus International University
- Sponsor type
- University, hospital or other
- Collaborators
- Near East University, Turkey
- Responsible party
- Sponsor
- Investigators
- Burcu Dikmen, PhD, Principal investigator, Cyprus International UniversityAlperhan ATEŞ, Principal investigator, Cyprus International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015879
- Sponsor's protocol ID
- TDP-RAM-
- Acronym
- RAM-TKA
- Status last verified
- Oct 2026
- First submitted
- 3 Jun 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07015879
- Acronym / sponsor ID
- RAM-TKA / TDP-RAM-
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cyprus International UniversityUniversity, hospital or other
- Collaborators
- Near East University, Turkey
- Study start
- 23 Mar 2025 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 14 Nov 2025 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 provided to patients undergoing surgery, and the effects of these interventions on comfort and quality of life were evaluated. The study aims to contribute to the enhancement of postoperative care practices and patient-centered nursing interventions for individuals undergoing total knee arthroplasty.
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, self-concept, role function, and interdependence modes, and for structuring nursing care plans accordingly.
This randomized controlled trial 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. Patients in the intervention group receive continuous care counseling and video-supported education based on the Roy Adaptation Model, while patients in the control group receive standard clinic care. Data are collected preoperatively, on the second postoperative day, and at the first and third months after discharge using standardized comfort and quality of life scales. The study aims to provide evidence on the effectiveness of model-based continuous nursing care in improving postoperative recovery and patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Continuous Care Counseling Based on the Roy Adaptation Model | Experimental | Behavioral: Continuous Care Counseling Based on the Roy Adaptation ModelPatients in the experimental group will receive video-supported education with verbal explanation in the clinic five days before surgery. The education will be repeated one day before surgery to assess the patient's understanding, and any gaps in knowledge will be addressed. On postoperative day 2, patients will receive practical education related to total knee arthroplasty. At discharge, patients will be provided with the educational video and instructed about home-care precautions. Overall comfort and quality of life will be assessed face-to-face five days before surgery and on postoperative day 2, and by telephone at the first and third months after discharge. During the telephone follow-ups, adherence to viewing the video and performing the prescribed exercises, as well as any postoperative complications, will be assessed. |
| Control Group | No intervention | –Patients will receive the clinic's routine treatment and nursing care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Able to speak, hear, and see
Key exclusion criteria (2 listed)
- Undergoing emergency surgery
- Readmitted for revision surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Care Counseling Based on the Roy Adaptation ModelPatients in the experimental group will receive video-supported education with verbal explanation in the clinic five days before surgery. The education will be repeated one day before surgery to assess the patient's understanding, and any gaps in knowledge will be addressed. On postoperative day 2, patients will receive practical education related to total knee arthroplasty. At discharge, patients will be provided with the educational video and instructed about home-care precautions. Overall comfort and quality of life will be assessed face-to-face five days before surgery and on postoperative day 2, and by telephone at the first and third months after discharge. During the telephone follow-ups, adherence to viewing the video and performing the prescribed exercises, as well as any postoperative complications, will be assessed. | Behavioural | Continuous Care Counseling Based on the Roy Adaptation Model |
Primary outcome
Overall Comfort Level Measured by the General Comfort Questionnaire Short Form
Time frame: Preoperative (5 days before surgery), postoperative 2nd day, and at the 1st and 3rd months after discharge
Patients' overall comfort will be assessed using the 28-item General Comfort Questionnaire Short Form. Items are rated from 1 to 6, and negatively worded items are reverse-coded. The total item score is divided by 28 to calculate a mean score ranging from 1 to 6. Higher scores indicate greater comfort.
1 secondary outcome
Overall Quality of Life Measured by the EuroQol 5-Dimension Questionnaire (EQ-5D) Index and Visual Analog Scale (VAS)
Time frame: Preoperative (5 days before surgery), postoperative 2nd day, and at the 1st and 3rd months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burcu Dikmen, PhD principal investigator
Cyprus International University
Alperhan ATEŞ principal investigator
Cyprus International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Care Counseling Based on the Roy Adaptation Model in people with Osteoarthritis and Care Model, run by Cyprus International University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Comfort Level Measured by the General Comfort Questionnaire Short Form (time frame: Preoperative (5 days before surgery), postoperative 2nd day, and at the 1st and 3rd months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.