Stress Ball Use During Chemotherapy in Gastrointestinal Cancer Patients
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: Gastrointestinal System Cancer. 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effect of Stress Ball on Anxiety, Fear and Vital Signs in Patients With Gastrointestinal System Cancer
Обзор
This study will investigate whether using a stress ball during chemotherapy can reduce anxiety, fear, and changes in vital signs in patients with gastrointestinal system cancers. Patients receiving chemotherapy for gastrointestinal cancers often experience anxiety and fear, which may affect their heart rate, blood pressure, and breathing. A stress ball is a simple, low-cost, and safe method that may help patients relax during treatment. In this randomized controlled study, 60 patients receiving chemotherapy will be assigned to either a stress ball group or a routine care group. Patients in the stress ball group will squeeze a stress ball for 15 minutes during their chemotherapy session. Anxiety, fear levels, and vital signs will be measured before and after chemotherapy in both groups. The results of this study may help determine whether stress ball use is an effective non-drug method to improve emotional well-being and physiological stability in patients undergoing chemotherapy.
Подробное описание
This study is a randomized controlled experimental trial designed to evaluate the effects of stress ball use during chemotherapy on anxiety, fear, and vital signs in patients with gastrointestinal system cancers.
Participants will be adult patients diagnosed with gastrointestinal system cancers who are receiving chemotherapy at the Artvin State Hospital Chemotherapy Unit. Eligible patients who provide informed consent will be randomly assigned in a 1:1 ratio to either an experimental group (stress ball intervention) or a control group (routine care).
Patients in the experimental group will be instructed to squeeze a medium-firm stress ball for 15 minutes starting at the beginning of their chemotherapy session. They will be guided to inhale while squeezing the ball and exhale while releasing it, focusing their attention on the activity. Patients in the control group will receive routine chemotherapy care without any additional intervention.
Anxiety and fear levels will be assessed before and after chemotherapy using validated measurement tools. Vital signs including blood pressure, heart rate, respiratory rate, body temperature, and oxygen saturation will also be recorded before and after the chemotherapy session. Outcomes will be compared between and within groups to determine the effectiveness of the stress ball intervention.
This study aims to provide evidence on whether a simple non-pharmacological method can improve psychological well-being and physiological stability during chemotherapy in patients with gastrointestinal system cancers.
Вмешательства
- Поведенческое Stress Ball
The intervention consists of guided stress ball squeezing during chemotherapy. A round, medium-firm, compressible stress ball approximately 5-6 cm in diameter will be provided to participants. Starting at the beginning of the chemotherapy session, participants will squeeze the stress ball continuously for 15 minutes. They will be instructed to inhale while squeezing the ball, exhale while releasing their grip, and focus their attention on the squeezing activity. Disposable gloves will be used to
Первичные конечные точки
- State Anxiety (STAI-State) score [Срок оценки: Baseline (before chemotherapy session) and immediately after chemotherapy session]
Вторичные конечные точки (7)
- Fear Severity (VAS-Fear) [Срок оценки: Baseline (before chemotherapy session) and immediately after chemotherapy session]
- Systolic Blood Pressure [Срок оценки: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.]
- Diastolic Blood Pressure [Срок оценки: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.]
- Heart Rate (Pulse) [Срок оценки: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.]
- Respiratory Rate [Срок оценки: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session]
- Body Temperature [Срок оценки: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.]
- Oxygen Saturation (SpO₂) [Срок оценки: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.]
Критерии участия
Критерии включения
- Being aged 18 years or older
- Having a diagnosis of gastrointestinal system cancer and receiving chemotherapy
- Having no communication problems
- Having no physical disability that would prevent squeezing a stress ball
- Willingness to participate in the study
Критерии исключения
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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
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
Turkey (Türkiye) · 1 центр
- Artvin State Hospital — Artvin
Идентификаторы
NCT: NCT07383935 · GIS-STRESSBALL-2026