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患者への創傷ケア教育が創傷ケア知識、セルフケア自己効力感、および回復の質に及ぼす影響

2026年11月9日 更新者:Yeliz Sürme、TC Erciyes University

人工関節置換術を受ける患者への創傷ケア教育が、創傷ケア知識、セルフケア自己効力感、および回復の質に及ぼす影響

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.

調査の概要

状態

積極的、募集していない

詳細な説明

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.

研究の種類

介入

入学 (実際)

50

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Melikgazi
      • Kayseri、Melikgazi、トルコ(Türkiye)
        • Erciyes University
      • Kayseri、Melikgazi、トルコ(Türkiye)
        • Health training and research hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

介入なし: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Knowledge Level
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Yeliz SÜRME, ASSOCIATE、TC Erciyes University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年10月10日

一次修了 (実際)

2026年6月20日

研究の完了 (推定)

2027年1月1日

試験登録日

最初に提出

2025年11月24日

QC基準を満たした最初の提出物

2025年11月24日

最初の投稿 (実際)

2025年12月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月10日

QC基準を満たした最後の更新が送信されました

2026年11月9日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2025/419

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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