The Effect of Stress Ball on Anxiety, Fear and Vital Signs in Patients With Gastrointestinal System Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- State Anxiety (STAI-State) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Stress Ball Intervention
Participants in this arm will receive routine chemotherapy care and will additionally perform stress ball squeezing for 15 minutes starting at the beginning of the chemotherapy session. Patients will be instructed to inhale while squeezing the ball and exhale while releasing it, focusing attention on the activity.
干预措施: Stress Ball (Behavioral)
Routine Care Control
Participants in this arm will receive routine chemotherapy care during their chemotherapy session and will not perform any stress ball or additional relaxation intervention.
结局指标
主要结局
State Anxiety (STAI-State) score
时间窗: Baseline (before chemotherapy session) and immediately after chemotherapy session
次要结局
- Body Temperature(Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.)
- Oxygen Saturation (SpO₂)(Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.)
- Heart Rate (Pulse)(Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.)
- Respiratory Rate(Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session)
- Fear Severity (VAS-Fear)(Baseline (before chemotherapy session) and immediately after chemotherapy session)
- Systolic Blood Pressure(Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.)
- Diastolic Blood Pressure(Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.)
研究者
EMRE ERKAL
The Effect of Stress Ball on Anxiety, Fear, and Vital Signs in Patients With Gastrointestinal System Cancer
Artvin Coruh University