NCT06267196

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Pain
• Anxiety

Interventions

Type	Name	Description
OTHER	The use of a stress ball	The effect of the stress ball used during spinal anesthesia on pain and anxiety

Timeline

• Start date: 2023-11-02
• Primary completion: 2024-03-02
• Completion: 2024-03-15
• First posted: 2024-02-20
• Last updated: 2024-02-20

Locations

2 sites across 1 country: Turkey (Türkiye)