The Effect of the Stress Ball Used During Spinal Anesthesia on Pain and Anxiety
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- stress ball and pain
研究概览
简要总结
The aim is to determine the impact of the stress ball used during spinal anesthesia on pain and anxiety levels
详细描述
Our planned study, which is intended to be conducted as a prospective randomized controlled trial, will include patients aged 18 and above who fall into category 3 and 4 according to the classification used in the study by Lucas et al., and who are undergoing cesarean section.Patient data including age, weight, height, body mass index (BMI), ASA (American Society of Anesthesiologists) score, gravidity, parity, history of abortion, gestational age, medical history, and surgical history will be recorded.The anxiety status of patients will be recorded using the State Anxiety Inventory (STAI-I) score both before and after the procedure.Patients will be divided into two groups using a randomization method. One group will be provided with a stress ball to squeeze during the administration of spinal anesthesia, while the second group will undergo spinal anesthesia without receiving a stress ball.All patients will receive intrathecal injection of 0.05% bupivacaine using a 25-gauge spinal needle. The Visual Analog Scale (VAS) will be assessed and recorded during the procedure to evaluate the patients' pain status.Additionally, the patient's blood pressure, pulse, and saturation levels will be recorded before starting the procedure and 2 minutes after the procedure initiation. Patient satisfaction will be evaluated after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 and above.
- •Patients with cesarean category 3 and 4.
排除标准
- •Patients under the age of 18
- •Patients undergoing emergency cesarean section
- •Patients with bleeding disorders
- •Individuals with psychological disorders
研究组 & 干预措施
Stress ball group
The patient group in which a stress ball is used during spinal anesthesia.
干预措施: The use of a stress ball (Other)
The control group
The group that receives only standard spinal anesthesia
结局指标
主要结局
stress ball and pain
时间窗: during the procedure
Evaluating the impact of stress ball usage during spinal anesthesia on pain through VAS (Visual Analog Scale) scoresThe VAS score ranges from 0 to 10, with higher values indicating more pain.
stress ball and anxiety
时间窗: Before and after the procedure, at 5 minutes.
The impact of stress ball use during spinal anesthesia on anxiety.The effect will be assessed with the STAI (State-Trait Anxiety Inventory)scale both before and after the procedure. On this scale, the minimum and maximum values range between 20 and 80, and higher values indicate greater stress.
次要结局
- Stress ball and blood pressure(Before and after the procedure, at 3 minutes.)
- Stress ball and pulse(Before and after the procedure, at 3 minutes.)
- Stress ball and saturation(Before and after the procedure, at 3 minutes.)
研究者
Özge Sayın Ayan
Principal Investigator
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
