Effect of AI-Assisted Respiratory Training on Pain, Fatigue and Respiratory Parameters in Patients After Open Heart Surgery
2026年6月22日 更新者：Yaren Yurdakul、Kocaeli University
The Effect of Artificial Intelligence-Assisted Respiratory Training on Pain, Fatigue and Respiratory Parameters in Patients After Open Heart Surgery
This randomized controlled study aims to evaluate the effect of artificial intelligence (AI)-assisted respiratory training on fatigue, pain, and respiratory parameters in patients after open heart surgery.
調査の概要
状態
募集
詳細な説明
Open heart surgery and related procedures (such as sternotomy, cardiopulmonary bypass, and chest tubes) can negatively affect pulmonary functions and cause postoperative pain, fatigue, and limited respiratory muscle function.
While standard care involves respiratory exercises, there is insufficient data regarding the combination of upper extremity Range of Motion (ROM) exercises with deep breathing.
This study will utilize AI-generated educational videos, created using tools like ChatGPT, Gemini, and Adobe Firefly, to guide patients in performing these exercises safely and correctly.
Participants will be randomized into three groups: a Rhythmic Breathing group, a Range of Motion-Deep Breathing (ROM-DB) group, and a Control group.
The interventions will be applied for three consecutive days.
The study will evaluate outcomes including respiratory rate, oxygen saturation, heart rate, pain levels, fatigue, dyspnea, and chest tube drainage volume.
研究の種類
介入
入学 (推定)
111
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。
研究連絡先
- 名前：Yaren Yurdakul, BSC
- 電話番号：+090 553 495 85 21
- メール：yarenyurdakl@gmail.com
研究連絡先のバックアップ
- 名前：Yasemin Özhanlı, PHD
- 電話番号：(0262) 303 47 01
- メール：yaseminozhanli@gmail.com
研究場所
-
-
İzmit
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Kocaeli、İzmit、トルコ（Türkiye）、41380
- 募集
- Kocaeli University
-
コンタクト：
- Yaren Yurdakul, BSC
- 電話番号：+090 553 495 85 21
- メール：yarenyurdakl@gmail.com
-
コンタクト：
- Yasemin Özhanlı, PHD
-
-
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Patients undergoing elective open heart surgery.
- Conscious.
- Speaks and understands Turkish.
- Has a chest tube inserted (on the right and/or left side).
- No visual, auditory, or mental problems.
- Willing to participate in the study.
Exclusion Criteria:
- Undergoing concurrent other chest surgery or having a history of re-surgery.
- Development of early postoperative complications (e.g., atelectasis) within 0-3 days.
- Any loss of an extremity.
- Long-term immobilization and intubation.
- Development of severe post-surgery infections (such as mediastinitis or sepsis) or respiratory complications (such as pneumonia or atelectasis).
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：ダブル
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：Rhythmic Breathing Group
Patients will watch an AI-generated video via tablet and simultaneously perform a 3x3x3 rhythmic breathing exercise, which consists of inhaling for 3 seconds, holding the breath for 3 seconds, and exhaling for 3 seconds.
The exercise will be repeated 5 times per session, once a day, for 3 days.
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Patients in this group will watch an artificial intelligence-generated educational video on a tablet.
Following the visual and auditory instructions in the video, they will perform a rhythmic breathing exercise consisting of inhaling for 3 seconds, holding the breath for 3 seconds, and exhaling for 3 seconds.
The exercise will be performed for 5 repetitions, once a day, for 3 consecutive days under the supervision of the researcher.
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|
実験的：Range of Motion-Deep Breathing (ROM-DN) Group
Patients will watch an AI-generated video via tablet and simultaneously perform upper extremity Range of Motion (ROM) exercises combined with deep breathing.
The exercise consists of 5 sets of controlled inspiration and expiration synchronized with arm abduction and adduction.
This will be applied once a day for 3 days.
|
Patients in this group will watch an artificial intelligence-generated educational video on a tablet.
They will perform upper extremity range of motion (abduction and adduction) exercises synchronized with deep inspiration and expiration.
This exercise will be performed for 5 repetitions, once a day, for 3 consecutive days under the supervision of the researcher.
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介入なし：Control Group
Patients in this group will not receive the study-specific video exercises.
They will be monitored under the clinic's standard routine care protocol, which includes standard breathing exercises and the use of an incentive spirometer (triflo).
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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 |
|---|---|---|
|
Change in Respiratory Rate
時間枠：Evaluated at baseline (before intervention), and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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Measured continuously as breaths per minute while the patient is at rest.
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Evaluated at baseline (before intervention), and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
|
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Change in Oxygen Saturation (SpO2)
時間枠：Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
|
Measured as a percentage (%) using a noninvasive pulse oximeter
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Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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Change in Heart Rate
時間枠：Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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Measured as beats per minute at rest using a noninvasive patient monitor.
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Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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Pain Level
時間枠：Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
|
Evaluated using the self-reported Numeric Rating Scale (NRS).
The scale ranges from 0 to 10, where "0" indicates no pain and "10" indicates unbearable pain.
Higher scores mean a worse outcome.
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Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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Fatigue Level
時間枠：Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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Evaluated using the Visual Analogue Scale (VAS).
The scale ranges from 0 to 10, where "0" indicates no fatigue and "10" indicates unbearable fatigue.
Higher scores represent increased fatigue.
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Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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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 |
|---|---|---|
|
Dyspnea Level
時間枠：Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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Evaluated using the Modified Borg Scale (CR-10), a category-ratio scale ranging from 0 (nothing at all) to 10. Higher scores indicate higher perceived exertion/dyspnea.
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Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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Chest Tube Drainage Level
時間枠：Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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The fluid level change in the chest tube drainage system, measured in centimeters (cm).
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Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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Presence of Chest Tube Tidaling
時間枠：Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session)
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Observational evaluation of fluid movement (tidaling) in the drainage system, recorded categorically as "movement present" or "no movement".
|
Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session)
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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：Yaren Yurdakul, BSC、Kocaeli University
- スタディチェア：Yasemin Özhanlı, PHD、Kocaeli University
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)
2026年2月10日
一次修了 (推定)
2026年8月1日
研究の完了 (推定)
2026年10月1日
試験登録日
最初に提出
2026年6月13日
QC基準を満たした最初の提出物
2026年6月22日
最初の投稿 (実際)
2026年6月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月24日
QC基準を満たした最後の更新が送信されました
2026年6月22日
最終確認日
2026年6月1日
詳しくは
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。