AR Health Education Video for Postoperative Breast Cancer Patients (AR-BCS)
Effects of AR Health Education Video Intervention on Anxiety and Depression in Postoperative Breast Cancer Patients
Breast cancer surgery patients may experience anxiety and depression before and after surgery. Health education can help patients understand the surgical process and postoperative care, but traditional education may not always be easy to understand.
This study evaluates whether augmented reality (AR) health education videos can help reduce anxiety and depression in postoperative breast cancer patients. Participants are randomly assigned to one of two groups. One group receives routine health education plus AR health education videos, and the other group receives routine health education only.
The study compares changes in anxiety, depression, and selected physiological indicators between the two groups before and after surgery.
調査の概要
詳細な説明
This is a randomized controlled study. Eligible breast cancer surgery patients are randomly assigned to an AR health education group or a routine health education group.
Participants in the AR health education group receive routine perioperative health education plus AR health education videos. Participants in the routine health education group receive routine perioperative health education only.
An outcome assessor who is blinded to group allocation collects questionnaire data before surgery, on postoperative day 1, and on postoperative day 2. Anxiety is measured using the State-Trait Anxiety Inventory-State Anxiety Scale (STAI-S), and depression is measured using the Beck Depression Inventory-II (BDI-II). Physiological indicators, including heart rate, respiratory rate, blood pressure, and oxygen saturation, are also collected.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Taichung City
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Taichung、Taichung City、台湾、435
- 募集
- Tungs' Taichung MetroHarbor Hospital
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コンタクト:
- Hsin-Hua Chen, RN, MSN
- 電話番号:+886919090022
- メール:yugagn@gmail.com
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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:
- Female patients aged 18 years or older with breast cancer.
- Breast cancer confirmed by pathological examination.
- Conscious and able to communicate in Mandarin or Taiwanese.
- No visual or hearing impairment.
- Willing to participate in this study and provide informed consent.
Exclusion Criteria:
- Patients with brain metastasis, dementia, or cognitive impairment.
- Patients currently taking antidepressants, anxiolytics, or other psychiatric medications.
- Patients diagnosed with psychiatric disorders.
- Patients with a history of hypertension.
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: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 |
|---|---|
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実験的:AR Health Education Group
Participants receive routine perioperative health education in addition to augmented reality (AR) health education videos related to breast cancer surgery and postoperative care.
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An augmented reality (AR)-based health education video designed to provide perioperative education, postoperative recovery guidance, daily activity adjustment, and self-care information for breast cancer surgery patients.
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アクティブコンパレータ:Routine Health Education Group
Routine perioperative health education provided according to standard clinical nursing care procedures.
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Routine perioperative health education provided according to standard clinical nursing care procedures.
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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 |
|---|---|---|
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State Anxiety
時間枠:Baseline, postoperative day 1, and postoperative day 2
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State anxiety is measured using the Chinese version of the State-Trait Anxiety Inventory-State Anxiety Scale (STAI-S).
The STAI-S includes 20 items rated on a 4-point Likert scale, with total scores ranging from 20 to 80. Higher scores indicate higher levels of state anxiety.
Scores of 20 to 39 indicate mild anxiety, 40 to 59 indicate moderate anxiety, and 60 to 80 indicate severe anxiety.
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Baseline, postoperative day 1, and postoperative day 2
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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 |
|---|---|---|
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Depression
時間枠:Baseline, postoperative day 1, and postoperative day 2
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Depression is measured using the Chinese version of the Beck Depression Inventory-II (BDI-II).
The BDI-II includes 21 items rated from 0 to 3, with total scores ranging from 0 to 63.
Higher scores indicate more severe depressive symptoms.
Scores of 0 to 16 indicate normal range, 17 to 22 indicate mild depression, 23 to 30 indicate moderate depression, and 31 to 63 indicate severe depression.
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Baseline, postoperative day 1, and postoperative day 2
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Physiological Indicators
時間枠:Baseline, postoperative day 1, and postoperative day 2
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Physiological indicators include heart rate, respiratory rate, systolic blood pressure, diastolic blood pressure, and peripheral oxygen saturation.
These indicators are collected to assess physiological responses related to anxiety during the perioperative period.
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Baseline, postoperative day 1, and postoperative day 2
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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
その他の研究ID番号
- TTMHH-R1140011 (その他の識別子:Research Department, Tungs' Taichung MetroHarbor Hospital)
- 113090 (その他の識別子:Institutional Review Board of Tungs' Taichung MetroHarbor Hospital)
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。