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Clinical Trial Summary

The aim is to determine the impact of the stress ball used during spinal anesthesia on pain and anxiety levels


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06267196
Study type Interventional
Source Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
Contact Özge Sayin Ayan
Phone +905332965628
Email ozgesayinayan@gmail.com
Status Recruiting
Phase N/A
Start date November 2, 2023
Completion date March 15, 2024

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