The Effect of the Stress Ball Used During Spinal Anesthesia on Pain and Anxiety
- Conditions
- AnxietyPain
- Interventions
- Other: The use of a stress ball
- Registration Number
- NCT06267196
- Lead Sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 140
- Patients aged 18 and above.
- Patients with cesarean category 3 and 4.
- Patients under the age of 18
- Patients undergoing emergency cesarean section
- Patients with bleeding disorders
- Individuals with psychological disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stress ball group The use of a stress ball The patient group in which a stress ball is used during spinal anesthesia.
- Primary Outcome Measures
Name Time Method stress ball and pain 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 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.
- Secondary Outcome Measures
Name Time Method Stress ball and blood pressure Before and after the procedure, at 3 minutes. The effect of the stress ball used during spinal anesthesia on the patient's blood pressure.It will be measured before and after the procedure and recorded in mmHg.
Stress ball and pulse Before and after the procedure, at 3 minutes. The impact of the use of the stress ball during spinal anesthesia on the pulse will be assessed.Pulse will be recorded as beats per minute.
Stress ball and saturation Before and after the procedure, at 3 minutes. The impact of using a stress ball during spinal anesthesia on saturation will be evaluated. It will be recorded in percentage.
Trial Locations
- Locations (2)
Özge Sayın Ayan
🇹🇷Istanbul, Eyup, Turkey
Prof.Dr.Cemil Tascioglu City Hospital
🇹🇷Istanbul, Şişli, Turkey