跳至主要内容
临床试验/NCT07264712
NCT07264712进行中(未招募)不适用

The Effect of Wound Care Education Given to Patients Undergoing Prosthetic Surgery on Wound Care Knowledge, Self-Care Self-Efficacy, and Quality of Recovery

TC Erciyes University4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
4
主要终点
Knowledge Level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

The person conducting the statistical analyses in the study will be blinded to the experimental groups.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.)

排除标准

  • Patients who have developed a surgical site infection
  • Illiterate
  • Unable to self-care
  • Previously had prosthetic surgery will not be included.

研究组 & 干预措施

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.

结局指标

主要结局

Knowledge Level

时间窗: 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

时间窗: 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

时间窗: 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.

Knowledge Level

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yeliz Sürme

associate professor

TC Erciyes University

研究点 (4)

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