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临床试验/NCT06267196
NCT06267196Unknown不适用

The Effect of the Stress Ball Used During Spinal Anesthesia on Pain and Anxiety

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization4 个研究点 分布在 2 个国家目标入组 140 人开始时间: 2023年11月2日最近更新:
适应症
干预措施

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

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

Active Comparator

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

No Intervention

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

发起方
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
申办方类型
Other
责任方
Principal Investigator
主要研究者

Özge Sayın Ayan

Principal Investigator

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (4)

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