QR Code Video Education for ICU Family Members (QR-ICU)
Effect of a QR Code-Based Digital Information Video on Knowledge and Anxiety Among Family Members of Intensive Care Unit Patients: A Prospective Randomized Controlled Trial
調査の概要
状態
詳細な説明
Family members of patients admitted to intensive care units frequently experience anxiety, uncertainty, and a need for information regarding the patient's condition and ICU procedures. Conventional verbal information may vary depending on time constraints, workload, and communication practices, resulting in inconsistent delivery of information.
This prospective randomized controlled trial will investigate whether a standardized QR code-based digital information video can improve knowledge and reduce anxiety among family members of ICU patients. Eligible first-degree relatives of ICU patients will be randomized into two groups. The control group will receive routine verbal information according to standard clinical practice. The intervention group will receive routine verbal information in addition to access to a QR code-based educational video.
The educational video will provide information regarding the ICU environment, monitoring systems, mechanical ventilation, sedation practices, common procedures, visiting policies, and frequently encountered clinical situations. The video is designed to provide standardized, understandable, and easily accessible information.
The primary outcome will be the total score of the Information Adequacy and Comprehensibility Questionnaire. Secondary outcomes will include anxiety scores measured using the Visual Analog Scale for Anxiety (VAS-A), satisfaction with information, and participant-reported adequacy of answers to their information needs. Assessments will be performed at baseline, within 24 hours after the intervention, and 72 hours after enrollment.
A total of 150 participants will be enrolled. The study is conducted at Elazig Fethi Sekin City Hospital.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Sevim Şenol Karataş, MD
- 電話番号：+905325736611
- メール：drsevimkaratas@gmail.com
研究連絡先のバックアップ
- 名前：Sait F Öner, MD
- 電話番号：+90 533 627 13 58
- メール：sfatihoner@gmail.com
研究場所
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Merkez
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Elâzığ、Merkez、トルコ（Türkiye）、23100
- Elazığ Fethi Sekin City Hospital
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コンタクト：
- Sevim Şenol Karataş, MD
- 電話番号：+905325736611
- メール：drsevimkaratas@gmail.com
-
主任研究者：
- Sevim Şenol Karataş, MD
-
コンタクト：
- Sait F Öner, MD
- 電話番号：+90 533 627 13 58
- メール：sfatihoner@gmail.com
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副調査官：
- Sait F Öner, MD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18 years or older
- First-degree family member of a patient admitted to the intensive care unit
- Able to read and understand Turkish
- Able to use a smartphone
- Able to access QR code-based educational materials
- Willing to participate and provide written informed consent
Exclusion Criteria:
- History of a diagnosed psychiatric disorder
- Current use of anxiolytic or antidepressant medication
- Visual or hearing impairment preventing participation in video-based education
- First-degree family member who is an active healthcare professional involved in patient care
- Inability to complete study questionnaires or follow-up assessments
- Refusal to participate in the study
研究計画
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Control Group
Participants receive routine verbal information regarding the intensive care unit and the patient's clinical condition according to standard clinical practice.
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実験的：QR Video Group
Participants receive routine verbal information in addition to access to a standardized QR code-based digital educational video about the intensive care unit, monitoring systems, mechanical ventilation, sedation, and common ICU procedures.
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A standardized QR code-based educational video providing information about the intensive care unit environment, monitoring systems, mechanical ventilation, sedation practices, visiting policies, and frequently encountered clinical situations.
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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 |
|---|---|---|
|
Information Adequacy and Comprehensibility Questionnaire Total Score
時間枠：72 hours after enrollment
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Total score of the Information Adequacy and Comprehensibility Questionnaire, a 15-item Likert-type questionnaire developed for this study.
Scores range from 15 to 75, with higher scores indicating better understanding and perceived adequacy of information.
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72 hours after enrollment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Anxiety Score Measured by Visual Analog Scale for Anxiety (VAS-A)
時間枠：72 hours after enrollment
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Participant-reported anxiety measured using a 0-10 Visual Analog Scale for Anxiety (VAS-A), where higher scores indicate greater anxiety.
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72 hours after enrollment
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Information Satisfaction Score
時間枠：72 hours after enrollment
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Participant satisfaction with information provided during the intensive care unit stay, measured using a 0-10 visual analog scale, with higher scores indicating greater satisfaction.
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72 hours after enrollment
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Resolution of Participant Information Needs
時間枠：72 hours after enrollment
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Participants rate the extent to which their most important information needs and questions were answered using a 0-10 scale, with higher scores indicating better resolution of information needs.
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72 hours after enrollment
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協力者と研究者
捜査官
- 主任研究者：Sevim Şenol Karataş, MD、Elazıg Fethi Sekin Sehir Hastanesi
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- QR Code-Family
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?
IPD プランの説明
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
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。