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Идёт набор NCT07251270

Effect of Stress Ball During Chest Tube Removal After Open Heart Surgery

Без фазы С лечением Pain Hemodynamic Changes Anxiety

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Stress ball.
Кому может быть актуально
Состояния в реестре: Pain, Hemodynamic Changes, Anxiety. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Effect of Stress Ball on Pain, Anxiety Levels, and Hemodynamic Variables During Chest Tube Removal After Open Heart Surgery

Обзор

15 minutes before the procedure, nurses (FEÖ and NT) will explain and demonstrate how to use the stress ball. The stress ball will be applied for approximately five minutes, including the chest tube removal procedure. A round, medium-hard, high-quality silicone ball, approximately 6 cm in diameter, will be used. Patients will be asked to hold the ball in their palms, count to three, squeeze, and release once. Patients will be instructed to continue this exercise until the chest tube removal procedure is completed, and then, under the supervision of the researcher, for approximately five minutes, focusing their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with disposable asepsis wipes before being administered to the patient. The control group will not receive any other treatment beyond routine treatment and will be assessed at the same time as the study group. The chest tube will be removed by a physician during the stress ball application. Procedural pain level, anxiety level and hemodynamic variables of all patients in the study and control groups will be re-evaluated immediately after chest tube removal and 15 and 30 minutes after chest tube removal.

Подробное описание

Chest tubes are routinely removed on the second or third postoperative day in patients in the Cardiovascular Surgery Intensive Care Unit, and patients with stable hemodynamic variables are discharged to the clinic. Morphine (0.01 mg) and paracetamol (if necessary) are used for routine analgesic treatment during the intensive care unit. Data will be collected between September 1, 2025, and September 1, 2026. Before the stress ball application after open heart surgery, participants in the control and study groups will be asked to complete the Descriptive Characteristics Form, VAS, VAS-A, and Hemodynamic Variables Monitoring Form. The Hemodynamic Variables Monitoring Form will be completed by the researcher (F.E.Ö) while monitoring the patient on the bedside monitor (Nihon Kohden, Tokyo). Participants who complete the Descriptive Characteristics Form, VAS, and VAS-A, and whose hemodynamic parameters are recorded, will be administered the stress ball application by Firdevs Ebru Özdemir and Nesrin Temiz.In addition to the clinic's routine treatment and care, patients in the study group will receive a stress ball during chest tube removal. 15 minutes before the procedure, nurses (FEÖ and NT) will explain and demonstrate how to use the stress ball. The stress ball will be applied for approximately five minutes, including the chest tube removal procedure. A round, medium-hard, high-quality silicone ball, approximately 6 cm in diameter, will be used. Patients will be asked to hold the ball in their palms, count to three, squeeze, and release once. Patients will be instructed to continue this exercise until the chest tube removal procedure is completed, and then, under the supervision of the researcher, for approximately five minutes, focusing their attention on the stress ball. The ball will be washed and cleaned after each use and wiped with disposable asepsis wipes before being administered to the patient. The control group will not receive any other treatment beyond routine treatment and will be assessed at the same time as the study group.

The chest tube will be removed by a physician during the stress ball application. Procedural pain level, anxiety level and hemodynamic variables of all patients in the study and control groups will be re-evaluated immediately after chest tube removal and 15 and 30 minutes after chest tube removal.

Вмешательства

  • Другое Stress ball
    Recently, the use of non-pharmacological methods applied by nurses has become increasingly widespread. One independent nursing practice for reducing pain and anxiety is the stress ball. A stress ball, one of these non-pharmacological methods, utilizes the sense of touch to divert attention and cognitive focus. This simple, reliable, and low-cost method reduces pain and anxiety by directing the mind to a salient stimulus.

Первичные конечные точки

  • Participants' pain levels with stress ball application [Срок оценки: Before, immediately after, 15 minutes and 30 minutes after chest tube removal]
Вторичные конечные точки (6)
  • anxiety [Срок оценки: Before, immediately after, 15 minutes and 30 minutes after chest tube removal]
  • Systolic blood pressure changes after stress ball [Срок оценки: Before, immediately after, 15 minutes and 30 minutes after chest tube removal]
  • Diastolic blood pressure changes after stress ball [Срок оценки: Before, immediately after, 15 minutes and 30 minutes after chest tube removal]
  • Heart rate changes after stress ball [Срок оценки: Before, immediately after, 15 minutes and 30 minutes after chest tube removal]
  • Respiratory rate changes after stress ball [Срок оценки: Before, immediately after, 15 minutes and 30 minutes after chest tube removal]
  • Oxygen saturation values changes after stress ball [Срок оценки: Before, immediately after, 15 minutes and 30 minutes after chest tube removal]

Критерии участия

Inclusion Criteria:Patients will be included : have only one chest tube after open heart surgery,

  • are 18 years of age or older,
  • are conscious and cooperative,
  • speak and understand Turkish,
  • have a stable general condition and hemodynamic variables,
  • have a planned surgical procedure,
  • have no previous chest tube experience,
  • have no psychiatric diagnosis,
  • are not using psychiatric and/or local neuromuscular blocking medications,
  • agree to participate in the study (sign the Informed Consent Form).

Exclusion Criteria:Patients who do not have a chest tube or have multiple chest tubes after open heart surgery,

  • Are under 18 years of age,
  • Are conscious and uncooperative,
  • Do not speak or understand Turkish,
  • Are in an unstable general condition or hemodynamic variables,
  • Have undergone emergency surgery,
  • Have previous chest tube placement experience,
  • Have a current psychiatric diagnosis,
  • Are taking psychiatric and/or local neuromuscular blocking medications,
  • Do not agree to participate in the study (do not sign the Informed Consent Form) will not be included in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Turkey, Mersin University, — Yenişehir

Публикации

  • Yarahmadi S, Mohammadi N, Ardalan A, Najafizadeh H, Gholami M. The combined effects of cold therapy and music therapy on pain following chest tube removal among patients with cardiac bypass surgery. Complement Ther Clin Pract. 2018 May;31:71-75. doi: 10.1016/j.ctcp.2018.01.006. Epub 2018 Feb 6. PMID 29705484

Идентификаторы

NCT: NCT07251270 · Mersin_Unı · Tuğba ÇAM YANIK

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗