Knee ArthroplastyNCT07201454
A Holistic Evaluation of the Effects of Healing Nursing Care Interventions on Frail Patient Undergoing Knee Arthroplasty and Their Caregivers
A study testing nursing care in people with Knee Arthroplasty, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- nursing care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 24 Aug 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient Inclusion Criteria:
- Speaking and understanding Turkish
- Being over 18 years of age
- Scoring 7 or higher on the Edmonton Vulnerability Scale
- Voluntary participation in the study
- Caregivers meeting the inclusion criteria
Show all 16Show fewer
- Undergoing knee arthroplasty surgery for the first time
- Caregiver Inclusion Criteria:
- 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
Who cannot join
- Patient-related exclusion criteria:
- 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
Show all 10Show fewer
- Caregiver-related exclusion criteria:
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk, Zubeyde Hanim St. No: 10, 24180 Erzincan Center/Erzincan, Erzincan, Erzincan 24180
Erzincan, Merkez, 24000
About this study
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.
Read the detailed description
Objective: This study was designed to holistically examine the effects of healing nursing care practices based on Watson's Theory of Human Caring on the feelings of entrapment, caregiver burden, and caregiving satisfaction of caregivers of frail patients undergoing knee arthroplasty, as well as their impact on patient satisfaction.
Method: This study was conducted as an embedded mixed-methods design [QUAN(qual)], combining a randomized controlled, pre-test/post-test experimental method (quantitative strand) with a phenomenological design based on Heidegger's hermeneutic approach (qualitative strand), with 50 frail patients (Edmonton Frailty Scale score ≥7) and their 50 primary caregivers who underwent/provided care for knee arthroplasty surgery at the Orthopedics and Traumatology Ward I-II of Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital between December 2025 and June 2026 (confirm exact end date - see note below). Patients and caregivers were assigned to experimental (n=25) and control (n=25) groups using simple randomization (1:1 allocation via www.randomizer.org). Blinding was not feasible, as data collection and intervention delivery were carried out by a single researcher and participants were aware of their group assignment.
Data collection: The Descriptive Characteristics Form was applied to patients and their primary caregivers before surgery. At the same time-point, the Feelings of Entrapment Scale, the clinic-adapted Zarit Caregiver Burden Scale, and the Caregiver Satisfaction Assessment Index (CASI-TR) were applied to the caregivers, and the Patient Satisfaction Assessment Form Based on Watson's Theory of Human Caring (first 5 items) was applied to the patients. Patients and caregivers in the experimental group then received structured nursing care based on the 5th, 7th, and 9th Caritas Processes of Watson's Theory of Human Caring, delivered from hospital admission through postoperative Day 4; the control group received routine ward care with no researcher intervention. On postoperative Day 4, the same instruments (Feelings of Entrapment Scale, Zarit Caregiver Burden Scale, and CASI-TR for caregivers; Patient Satisfaction Assessment Form for patients) were re-administered to both groups. On the same day, semi-structured interviews were conducted individually with all patients (n=25) and caregivers (n=25) in the experimental group only; responses were transcribed verbatim without researcher commentary and, with participant consent, audio-recorded to prevent data loss and allow later review.
Original Value: No prior studies were found in the literature evaluating the theoretical basis of caregiver care for frail patients undergoing knee arthroplasty, caregiving satisfaction, feelings of entrapment, or patient satisfaction in this population. The study therefore has original value and contributes to national and international literature. Its findings introduce a holistic, theory-based (Watson's Theory of Human Caring) nursing care model for frail patients undergoing knee arthroplasty and their caregivers.
Expected Outcome: The findings demonstrated that the intervention reduced caregivers' feelings of entrapment and caregiver burden while increasing caregiving satisfaction, and significantly increased patient satisfaction compared with routine care, supporting improved patient-family interaction and more effective, theory-based nursing care.
- Conditions
- Knee Arthroplasty
- Being tested
- nursing care
- Keywords
- knee arthroplasty, fragile patient, care burden, feeling stuck, caregiver, human care theory
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nursing careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 days before and 4 days after application; supplementary open-ended follow-up by telephone with patients on post-discharge Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Dec 2025
- Primary completion30 Jun 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknaz Kara, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201454
- Sponsor's protocol ID
- Ilknaz_Doktara_Tezi
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Holistic Evaluation of the Effects of Healing Nursing Care Interventions on Frail Patient Undergoing Knee Arthroplasty and Their Caregivers
- ClinicalTrials.gov ID
- NCT07201454
- Acronym / sponsor ID
- Ilknaz_Doktara_Tezi
- Conditions
- Knee Arthroplasty
- Keywords
- knee arthroplasty, fragile patient, care burden, feeling stuck, caregiver, human care theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 1 Oct 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.
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.
Detailed description
Objective: This study was designed to holistically examine the effects of healing nursing care practices based on Watson's Theory of Human Caring on the feelings of entrapment, caregiver burden, and caregiving satisfaction of caregivers of frail patients undergoing knee arthroplasty, as well as their impact on patient satisfaction.
Method: This study was conducted as an embedded mixed-methods design [QUAN(qual)], combining a randomized controlled, pre-test/post-test experimental method (quantitative strand) with a phenomenological design based on Heidegger's hermeneutic approach (qualitative strand), with 50 frail patients (Edmonton Frailty Scale score ≥7) and their 50 primary caregivers who underwent/provided care for knee arthroplasty surgery at the Orthopedics and Traumatology Ward I-II of Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital between December 2025 and June 2026 (confirm exact end date - see note below). Patients and caregivers were assigned to experimental (n=25) and control (n=25) groups using simple randomization (1:1 allocation via www.randomizer.org). Blinding was not feasible, as data collection and intervention delivery were carried out by a single researcher and participants were aware of their group assignment.
Data collection: The Descriptive Characteristics Form was applied to patients and their primary caregivers before surgery. At the same time-point, the Feelings of Entrapment Scale, the clinic-adapted Zarit Caregiver Burden Scale, and the Caregiver Satisfaction Assessment Index (CASI-TR) were applied to the caregivers, and the Patient Satisfaction Assessment Form Based on Watson's Theory of Human Caring (first 5 items) was applied to the patients. Patients and caregivers in the experimental group then received structured nursing care based on the 5th, 7th, and 9th Caritas Processes of Watson's Theory of Human Caring, delivered from hospital admission through postoperative Day 4; the control group received routine ward care with no researcher intervention. On postoperative Day 4, the same instruments (Feelings of Entrapment Scale, Zarit Caregiver Burden Scale, and CASI-TR for caregivers; Patient Satisfaction Assessment Form for patients) were re-administered to both groups. On the same day, semi-structured interviews were conducted individually with all patients (n=25) and caregivers (n=25) in the experimental group only; responses were transcribed verbatim without researcher commentary and, with participant consent, audio-recorded to prevent data loss and allow later review.
Original Value: No prior studies were found in the literature evaluating the theoretical basis of caregiver care for frail patients undergoing knee arthroplasty, caregiving satisfaction, feelings of entrapment, or patient satisfaction in this population. The study therefore has original value and contributes to national and international literature. Its findings introduce a holistic, theory-based (Watson's Theory of Human Caring) nursing care model for frail patients undergoing knee arthroplasty and their caregivers.
Expected Outcome: The findings demonstrated that the intervention reduced caregivers' feelings of entrapment and caregiver burden while increasing caregiving satisfaction, and significantly increased patient satisfaction compared with routine care, supporting improved patient-family interaction and more effective, theory-based nursing care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: nursing careThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Speaking and understanding Turkish
- Being over 18 years of age
- Scoring 7 or higher on the Edmonton Vulnerability Scale
- Voluntary participation in the study
- Caregivers meeting the inclusion criteria
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| nursing careThe 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. | Behavioural | Experimental group |
Primary outcome
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 days before and 4 days after application; supplementary open-ended follow-up by telephone with patients on post-discharge Day 7
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 8 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nursing care in people with Knee Arthroplasty, run by Ataturk 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 16 inclusion and 10 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 8 Sep 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?
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. (time frame: 4 days before and 4 days after application; supplementary open-ended follow-up by telephone with caregivers on post-discharge Day 7). The study lists 4 primary outcomes in all. 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 8 Sep 2026.