Effects of Stress Ball Use and Breathing Exercises on Pain and Vital Signs During Drain Removal After Total Knee Arthroplasty (TDP)
The Effect of Stress Ball Use and Breathing Exercises on Procedural Pain and Vital Signs During Drain Removal After Total Knee Arthroplasty: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of stress ball use and breathing exercises on procedural pain and vital signs during drain removal in patients undergoing total knee arthroplasty. Although drain removal is a short procedure, it is often associated with sudden and intense pain and may trigger physiological stress responses such as increased heart rate, blood pressure, and respiratory rate.
A total of 105 patients will be randomly assigned to three groups: stress ball group, breathing exercise group, and standard care group. The interventions will be applied starting one minute before drain removal, continuing throughout the procedure, and for two minutes afterward.
Pain levels will be assessed using the Numeric Rating Scale (NRS), and vital signs (heart rate, blood pressure, respiratory rate, and oxygen saturation) will be measured at predefined time points before, during, and after the procedure. The findings of this study are expected to provide evidence on the effectiveness of simple, non-pharmacological interventions in reducing procedural pain and improving physiological stability during drain removal
調査の概要
状態
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：HÜMEYRA YÜKSEL, Ph.D
- 電話番号：+905538748327
- メール：humeyragecici@gmail.com
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults aged 18 years and older undergoing primary total knee arthroplasty
- Patients with a surgical drain in place and scheduled for drain removal in the postoperative period
- Able to provide informed consent
- Able to communicate and understand instructions
Exclusion Criteria:
- Patients with chronic pain syndromes or regular opioid use
- Patients with cognitive impairment, delirium, or communication difficulties
- Patients with contraindications to drain removal (e.g., active bleeding, hemodynamic instability)
- Patients with neurological conditions affecting pain perception
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：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 |
|---|---|
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アクティブコンパレータ：Stress Ball Group
Patients use a stress ball during drain removal
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Participants will be provided with a medium-resistance stress ball and instructed to rhythmically squeeze and release it starting one minute before drain removal, continuing throughout the procedure, and for two minutes after the procedure.
A brief explanation will be given prior to the intervention.
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アクティブコンパレータ：Breathing Exercise Group
Patients perform breathing exercises during drain remo
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Participants will be instructed in diaphragmatic breathing techniques before the procedure.
They will begin deep breathing one minute before drain removal, continue throughout the procedure, and for two minutes afterward.
The technique includes slow inhalation through the nose, holding the breath for a few seconds, and slow exhalation through the mouth.
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プラセボコンパレーター：Control Group
Patients receive standard care during drain removal.
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Participants will receive standard care, including routine information about the drain removal procedure, without any additional intervention such as stress ball use or breathing exercises.
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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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Pain Intensity (Numeric Rating Scale, NRS
時間枠：Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
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Pain intensity will be assessed using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates the worst possible pain.
Pain levels will be recorded during and after drain removal.
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Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
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Heart Rate
時間枠：Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
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Heart rate (beats per minute) will be measured to assess physiological response to pain during drain removal.
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Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
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Blood Pressure
時間枠：Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
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Systolic and diastolic blood pressure (mmHg) will be measured to evaluate physiological stress response.
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Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
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Oxygen Saturation
時間枠：Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
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Peripheral oxygen saturation (%) will be measured using a pulse oximeter.
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Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
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Respiratory Rate
時間枠：Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
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Respiratory rate (breaths per minute) will be recorded.
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Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.
- 17. Ataman Yıldız G, Çınar F, Kadiroğulları E, Eti Aslan F. The effect of applications on pain after open and closed heart surgery: Descriptive research. Turkiye Klinikleri J Cardiovasc Sci. 2024;36(1):1-10.
- Bahar A, Yardimci I. Effect of breathing exercises applied before chest tube removal on pain and anxiety levels: descriptive and correlational research. Psychol Health Med. 2025 Dec;30(10):2388-2398. doi: 10.1080/13548506.2025.2519221. Epub 2025 Jun 25.
- 1. Kuzuca BC, Güçlü B. Total diz artroplastisi öncesi planlama. TOTBİD Dergisi. 2021;20:507-514.
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
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