Effects of Stress Ball Use and Breathing Exercises on Pain and Vital Signs During Drain Removal After Total Knee Arthroplasty

Официальное название

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

Обзор

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

Вмешательства

• Поведенческое 3. Control Group Description
  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.
• Поведенческое 1. Stress Ball Intervention Description
  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.
• Поведенческое 2. Breathing Exercise Intervention Description
  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.

Первичные конечные точки

• Pain Intensity (Numeric Rating Scale, NRS [Срок оценки: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur]
• Heart Rate [Срок оценки: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur]
• Blood Pressure [Срок оценки: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur]
• Oxygen Saturation [Срок оценки: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur]
• Respiratory Rate [Срок оценки: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 40560956
• 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. PMID 35397973
• 1. Kuzuca BC, Güçlü B. Total diz artroplastisi öncesi planlama. TOTBİD Dergisi. 2021;20:507-514.

Идентификаторы

NCT: NCT07586436 · HY-TDP-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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