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

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Status: Enrolling

Conditions: Anxiety; Pain

Treatments: Other: The use of a stress ball

Study type: Interventional

Funder types: Other

Identifiers

NCT06267196

CemilTascıogluERHO-AYAN

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients aged 18 and above.
• Patients with cesarean category 3 and 4.

Exclusion criteria

• Patients under the age of 18
• Patients undergoing emergency cesarean section
• Patients with bleeding disorders
• Individuals with psychological disorders

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Stress ball group

Active Comparator group

Description:

The patient group in which a stress ball is used during spinal anesthesia.

Treatment:

Other: The use of a stress ball

The control group

No Intervention group

Description:

The group that receives only standard spinal anesthesia