- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07264712
The Effect of Wound Care Education Given to Patients on Wound Care Knowledge, Self-Care Self-Efficacy, and Quality of Recovery
The Effect of Wound Care Education Given to Patients Undergoing Prosthetic Surgery on Wound Care Knowledge, Self-Care Self-Efficacy, and Quality of Recovery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Melikgazi
-
Kayseri, Melikgazi, Turkey (Türkiye)
- Erciyes University
-
Kayseri, Melikgazi, Turkey (Türkiye)
- Health training and research hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.)
Exclusion Criteria:
- Patients who have developed a surgical site infection
- Illiterate
- Unable to self-care
- Previously had prosthetic surgery will not be included.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
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.
|
|
|
Experimental: Education group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
postoperative day 3
|
|
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.
|
15th day after surgery
|
|
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.
|
15th day after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yeliz SÜRME, ASSOCIATE, TC Erciyes University
Publications and helpful links
General Publications
- 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.
- Yu 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.
- 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
- Chica-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.
- Ismail 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025/419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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