Prosthetic TreatmentNCT07264712
The Effect of Wound Care Education Given to Patients on Wound Care Knowledge, Self-Care Self-Efficacy, and Quality of Recovery
A study testing artificial intelligence-supported education in people with Prosthetic Treatment and Wound Care, run by TC Erciyes University at 2 sites in Turkey (Türkiye).
Trial summary
This study will be conducted as a randomized controlled trial to determine the impact of artificial intelligence-assisted wound care training provided to patients undergoing prosthetic surgery on their wound care knowledge, quality of healing, and self-care self-efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Treatment, Wound Care, Education
- What is being tested?
- artificial intelligence-supported education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Oct 2025to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Those undergoing total hip or knee replacement surgery
- Those who volunteer to participate in the study
- Those over 18 years of age
- Those who have no communication problems (language, hearing impairment, etc.)
Who cannot join
- Patients who have developed a surgical site infection
- Illiterate
- Unable to self-care
- Previously had prosthetic surgery will not be included.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Erciyes University
Kayseri, Melikgazi
Health training and research hospital
Kayseri, Melikgazi
About this study
Official title: The Effect of Wound Care Education Given to Patients Undergoing Prosthetic Surgery on Wound Care Knowledge, Self-Care Self-Efficacy, and Quality of Recovery
This study will be conducted as a randomized controlled trial to determine the impact of artificial intelligence-assisted wound care training provided to patients undergoing prosthetic surgery on their wound care knowledge, quality of healing, and self-care self-efficacy. It was planned to include 22 individuals in the experimental group and 22 in the control group. However, considering the potential for data loss, the study was planned to be completed with a total of 50 individuals: 25 in the experimental group and 25 in the control group. Patient Identification Form, Patient Follow-up Form, Knowledge Level Questionnaire, Self-Care Self-Efficacy Scale and Quality of Recovery (QoR-15) Scale were used to collect data.
Read the detailed description
It is crucial to educate patients and their caregivers who have undergone prosthetic surgeries such as TKA and THA about home care before discharge. Therefore, this study will be conducted as a randomized controlled trial to determine the impact of artificial intelligence-assisted wound care training provided to patients undergoing prosthetic surgery on their wound care knowledge, quality of healing, and self-care self-efficacy. The study population will consist of patients hospitalized in the Orthopedics and Traumatology Department of Erciyes University Health Application and Research Center after total hip and knee replacement surgeries, and the sample will consist of patients who meet the inclusion criteria. With 80% power, an effect size of 0.776, and a 95% confidence interval, it was planned to include 22 individuals in the experimental group and 22 in the control group. However, considering the potential for data loss, the study was planned to be completed with a total of 50 individuals: 25 in the experimental group and 25 in the control group. Patient Identification Form, Patient Follow-up Form, Knowledge Level Questionnaire, Self-Care Self-Efficacy Scale and Quality of Recovery (QoR-15) Scale were used to collect data.
Research data will be collected by the researcher between October 2025 and March 2026. The firstly, begins with the patients' hospitalization prior to surgery, and the assignment to either the experimental or control groups will be determined.
- Conditions
- Prosthetic Treatment, Wound Care, Education
- Being tested
- artificial intelligence-supported education
- Keywords
- Wound care, Prosthetic surgery, artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artificial intelligence-supported educationOther
The purpose of the study will be explained to the individuals in the experimental group using a face-to-face interview technique, and a patient introduction form will be administered by the researcher one day before surgery. The researcher will then provide patients with visual and verbal wound care training using the "Surgical Patient Wound Care Guide," and the educational materials will be provided. To assess the effectiveness of the training, a Knowledge Level Survey consisting of 10 true/false questions will be administered to patients on the third postoperative day. Two weeks after surgery, the Patient Follow-up Form, Self-Care Self-Efficacy Scale, and Quality of Healing Scale will be completed by phone.
| Study group | Role | What they receive |
|---|---|---|
| Education group | Experimental | The purpose of the study will be explained to the individuals in the experimental group using a face-to-face interview technique, and a patient introduction form will be administered by the researcher one day before surgery. The researcher will then provide patients with visual and verbal wound care training using the "Surgical Patient Wound Care Guide," and the educational materials will be provided. To assess the effectiveness of the training, a Knowledge Level Survey consisting of 10 true/false questions will be administered to patients on the third postoperative day. Two weeks after surgery, the Patient Follow-up Form, Self-Care Self-Efficacy Scale, and Quality of Healing Scale will be completed by phone. Receives: Other: artificial intelligence-supported education |
| Control Group | No intervention | The purpose of the study will be explained to the control group members, and a patient introduction form will be administered by the researcher using a face-to-face interview technique one day before surgery. On the third postoperative day, patients will be administered a Knowledge Level Questionnaire consisting of 10 true/false questions. Two weeks after surgery, the patient follow-up form, the Self-Care Self-Efficacy Scale, and the Quality of Recovery Scale will be completed by phone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Level
The researcher-created knowledge survey includes 10 true/false questions aimed at measuring the effectiveness of Surgical Patient Wound Care Education provided to patients. Each question will be evaluated out of 10. The lowest possible score is 0, and the highest is 100. Higher scores indicate higher knowledge levels. Expert opinions will be obtained from three faculty members with expertise in the field to assess the adequacy of the survey's content and scope.
Measured: postoperative day 3
Self-Care Self-Efficacy
The scale originally developed by Yu et al. to determine individuals' self-care self-efficacy levels was modified by Chica-Pérez et al. to assess self-care self-efficacy in older adults with chronic multimorbidity. The scale was designed as a 5-point Likert-type instrument ranging from "1 = I do not trust myself" to "5 = I trust myself a lot." It consists of 10 items in total. In their study, Chica-Pérez et al. reported Cronbach's alpha coefficients as 0.713 for the subscale "Self-Efficacy in Clinical Knowledge-Based Self-Care Behaviors," 0.822 for "Self-Efficacy in Self-Care," 0.881 for "Self-Efficacy in Monitoring Self-Care," and 0.878 for "Self-Efficacy in Self-Care Management." Chica-Pérez et al. stated that the minimum possible score is 10 and the maximum is 50, with higher scores indicating higher levels of self-efficacy in self-care.
Measured: 15th day after surgery
Quality of Recovery
The Quality of Recovery-15 (QoR-15) is a brief postoperative recovery scale developed and validated by Stark et al. in 2013. It is a shortened version of the QoR-40 scale. It is easier to use because it is shorter and can be completed in a shorter time. Like the QoR-40, it contains 15 questions that assess the patient's pain, physical comfort, physical independence, psychological support, and emotional state. The test results in a score between 0 and 150, with a higher score indicating better recovery quality. With the latest update, the minimal clinically important difference, that is, the lowest difference indicating a meaningful change, is 6 for the QoR-15.
Measured: 15th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start10 Oct 2025
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prosthetic TreatmentStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- designed as a randomized controlled experimental
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Sürme, TC Erciyes University
- Investigators
- Yeliz SÜRME, ASSOCIATE, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264712
- Sponsor's protocol ID
- 2025/419
- Status last verified
- May 2026
- First submitted
- 24 Nov 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yıldız GN. Öz bakım öz yeterlilik ölçeği'nin Türkçe geçerlik güvenirliğinin sağlanması: Metodolojik bir araştırma. Turkiye Klinikleri J Nurs Sci, 2025;17(1), 174-183. https://doi.org/10.5336/nurses.2024-105063
Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.
PubMed 35430086Chica-Perez A, Dobarrio-Sanz I, Correa-Casado M, Fernandez-Sola C, Ruiz-Fernandez MD, Hernandez-Padilla JM. Spanish version of the self-care self-efficacy scale: A validation study in community-dwelling older adults with chronic multimorbidity. Geriatr Nurs. 2023 Sep-Oct;53:181-190. doi: 10.1016/j.gerinurse.2023.07.016. Epub 2023 Aug 2.
PubMed 37540914Yu DS, De Maria M, Barbaranelli C, Vellone E, Matarese M, Ausili D, Rejane RE, Osokpo OH, Riegel B. Cross-cultural applicability of the Self-Care Self-Efficacy Scale in a multi-national study. J Adv Nurs. 2021 Feb;77(2):681-692. doi: 10.1111/jan.14617. Epub 2020 Dec 9.
PubMed 33295675Ismail EA, Elshafie MA. Patient-reported outcomes after femoral nerve block versus periarticular injections in patients undergoing total knee arthroplasty: A randomized controlled study. Journal of Cleaner Production, 2021;277(12):123958 https://doi.org/10.1016/j.jclepro.2020.123958
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Wound Care Education Given to Patients Undergoing Prosthetic Surgery on Wound Care Knowledge, Self-Care Self-Efficacy, and Quality of Recovery
- ClinicalTrials.gov ID
- NCT07264712
- Acronym / sponsor ID
- 2025/419
- Conditions
- Prosthetic Treatment, Wound Care, Education
- Keywords
- Wound care, Prosthetic surgery, artificial intelligence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 4 Dec 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 will be conducted as a randomized controlled trial to determine the impact of artificial intelligence-assisted wound care training provided to patients undergoing prosthetic surgery on their wound care knowledge, quality of healing, and self-care self-efficacy. It was planned to include 22 individuals in the experimental group and 22 in the control group. However, considering the potential for data loss, the study was planned to be completed with a total of 50 individuals: 25 in the experimental group and 25 in the control group. Patient Identification Form, Patient Follow-up Form, Knowledge Level Questionnaire, Self-Care Self-Efficacy Scale and Quality of Recovery (QoR-15) Scale were used to collect data.
Detailed description
It is crucial to educate patients and their caregivers who have undergone prosthetic surgeries such as TKA and THA about home care before discharge. Therefore, this study will be conducted as a randomized controlled trial to determine the impact of artificial intelligence-assisted wound care training provided to patients undergoing prosthetic surgery on their wound care knowledge, quality of healing, and self-care self-efficacy. The study population will consist of patients hospitalized in the Orthopedics and Traumatology Department of Erciyes University Health Application and Research Center after total hip and knee replacement surgeries, and the sample will consist of patients who meet the inclusion criteria. With 80% power, an effect size of 0.776, and a 95% confidence interval, it was planned to include 22 individuals in the experimental group and 22 in the control group. However, considering the potential for data loss, the study was planned to be completed with a total of 50 individuals: 25 in the experimental group and 25 in the control group. Patient Identification Form, Patient Follow-up Form, Knowledge Level Questionnaire, Self-Care Self-Efficacy Scale and Quality of Recovery (QoR-15) Scale were used to collect data.
Research data will be collected by the researcher between October 2025 and March 2026. The firstly, begins with the patients' hospitalization prior to surgery, and the assignment to either the experimental or control groups will be determined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- designed as a randomized controlled experimental
| Arm | Type | Receives |
|---|---|---|
| Education group | Experimental | Other: artificial intelligence-supported educationThe purpose of the study will be explained to the individuals in the experimental group using a face-to-face interview technique, and a patient introduction form will be administered by the researcher one day before surgery. The researcher will then provide patients with visual and verbal wound care training using the "Surgical Patient Wound Care Guide," and the educational materials will be provided. To assess the effectiveness of the training, a Knowledge Level Survey consisting of 10 true/false questions will be administered to patients on the third postoperative day. Two weeks after surgery, the Patient Follow-up Form, Self-Care Self-Efficacy Scale, and Quality of Healing Scale will be completed by phone. |
| Control Group | No intervention | –The purpose of the study will be explained to the control group members, and a patient introduction form will be administered by the researcher using a face-to-face interview technique one day before surgery. On the third postoperative day, patients will be administered a Knowledge Level Questionnaire consisting of 10 true/false questions. Two weeks after surgery, the patient follow-up form, the Self-Care Self-Efficacy Scale, and the Quality of Recovery Scale will be completed by phone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those undergoing total hip or knee replacement surgery
- Those who volunteer to participate in the study
- Those over 18 years of age
- Those who have no communication problems (language, hearing impairment, etc.)
Key exclusion criteria (4 listed)
- Patients who have developed a surgical site infection
- Illiterate
- Unable to self-care
- Previously had prosthetic surgery will not be included.
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 |
|---|---|---|
| artificial intelligence-supported educationThe purpose of the study will be explained to the individuals in the experimental group using a face-to-face interview technique, and a patient introduction form will be administered by the researcher one day before surgery. The researcher will then provide patients with visual and verbal wound care training using the "Surgical Patient Wound Care Guide," and the educational materials will be provided. To assess the effectiveness of the training, a Knowledge Level Survey consisting of 10 true/false questions will be administered to patients on the third postoperative day. Two weeks after surgery, the Patient Follow-up Form, Self-Care Self-Efficacy Scale, and Quality of Healing Scale will be completed by phone. | Other | Education group |
Primary outcome
Knowledge Level
Time frame: postoperative day 3
The researcher-created knowledge survey includes 10 true/false questions aimed at measuring the effectiveness of Surgical Patient Wound Care Education provided to patients. Each question will be evaluated out of 10. The lowest possible score is 0, and the highest is 100. Higher scores indicate higher knowledge levels. Expert opinions will be obtained from three faculty members with expertise in the field to assess the adequacy of the survey's content and scope.
Self-Care Self-Efficacy
Time frame: 15th day after surgery
The scale originally developed by Yu et al. to determine individuals' self-care self-efficacy levels was modified by Chica-Pérez et al. to assess self-care self-efficacy in older adults with chronic multimorbidity. The scale was designed as a 5-point Likert-type instrument ranging from "1 = I do not trust myself" to "5 = I trust myself a lot." It consists of 10 items in total. In their study, Chica-Pérez et al. reported Cronbach's alpha coefficients as 0.713 for the subscale "Self-Efficacy in Clinical Knowledge-Based Self-Care Behaviors," 0.822 for "Self-Efficacy in Self-Care," 0.881 for "Self-Efficacy in Monitoring Self-Care," and 0.878 for "Self-Efficacy in Self-Care Management." Chica-Pérez et al. stated that the minimum possible score is 10 and the maximum is 50, with higher scores indicating higher levels of self-efficacy in self-care.
Quality of Recovery
Time frame: 15th day after surgery
The Quality of Recovery-15 (QoR-15) is a brief postoperative recovery scale developed and validated by Stark et al. in 2013. It is a shortened version of the QoR-40 scale. It is easier to use because it is shorter and can be completed in a shorter time. Like the QoR-40, it contains 15 questions that assess the patient's pain, physical comfort, physical independence, psychological support, and emotional state. The test results in a score between 0 and 150, with a higher score indicating better recovery quality. With the latest update, the minimal clinically important difference, that is, the lowest difference indicating a meaningful change, is 6 for the QoR-15.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- BackgroundYıldız GN. Öz bakım öz yeterlilik ölçeği'nin Türkçe geçerlik güvenirliğinin sağlanması: Metodolojik bir araştırma. Turkiye Klinikleri J Nurs Sci, 2025;17(1), 174-183. https://doi.org/10.5336/nurses.2024-105063
- Background: PubMed 35430086Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.
- Background: PubMed 37540914Chica-Perez A, Dobarrio-Sanz I, Correa-Casado M, Fernandez-Sola C, Ruiz-Fernandez MD, Hernandez-Padilla JM. Spanish version of the self-care self-efficacy scale: A validation study in community-dwelling older adults with chronic multimorbidity. Geriatr Nurs. 2023 Sep-Oct;53:181-190. doi: 10.1016/j.gerinurse.2023.07.016. Epub 2023 Aug 2.
- Background: PubMed 33295675Yu DS, De Maria M, Barbaranelli C, Vellone E, Matarese M, Ausili D, Rejane RE, Osokpo OH, Riegel B. Cross-cultural applicability of the Self-Care Self-Efficacy Scale in a multi-national study. J Adv Nurs. 2021 Feb;77(2):681-692. doi: 10.1111/jan.14617. Epub 2020 Dec 9.
- BackgroundIsmail EA, Elshafie MA. Patient-reported outcomes after femoral nerve block versus periarticular injections in patients undergoing total knee arthroplasty: A randomized controlled study. Journal of Cleaner Production, 2021;277(12):123958 https://doi.org/10.1016/j.jclepro.2020.123958
- 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.
Yeliz SÜRME, ASSOCIATE principal investigator
TC Erciyes University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing artificial intelligence-supported education in people with Prosthetic Treatment and Wound Care, run by TC Erciyes University at 2 sites 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Knowledge Level (time frame: postoperative day 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07264712, which also lists 5 linked publications.
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 26 May 2026.