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

Pain Clinical Trial

— stressball  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06267196
• Other study ID #: CemilTasciogluERHO-AYAN
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: February 2024
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: Özge Sayin Ayan
• Phone: +905332965628
• Email: ozgesayinayan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 15, 2024
• Est. primary completion date: March 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

Other:
• The use of a stress ball
The effect of the stress ball used during spinal anesthesia on pain and anxiety

Locations

Country	Name	City	State
Turkey	Özge Sayin Ayan	Istanbul	Eyup
Turkey	Prof.Dr.Cemil Tascioglu City Hospital	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Hudson BF, Ogden J, Whiteley MS. Randomized controlled trial to compare the effect of simple distraction interventions on pain and anxiety experienced during conscious surgery. Eur J Pain. 2015 Nov;19(10):1447-55. doi: 10.1002/ejp.675. Epub 2015 Jan 30. — View Citation

Kumar S, Gautam SK, Gupta D, Agarwal A, Dhirraj S, Khuba S. The effect of Valsalva maneuver in attenuating skin puncture pain during spinal anesthesia: a randomized controlled trial. Korean J Anesthesiol. 2016 Feb;69(1):27-31. doi: 10.4097/kjae.2016.69.1.27. Epub 2016 Jan 28. — View Citation

Yanes AF, Weil A, Furlan KC, Poon E, Alam M. Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision: A Randomized Clinical Trial. JAMA Dermatol. 2018 Sep 1;154(9):1045-1049. doi: 10.1001/jamadermatol.2018.1783. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stress ball and anxiety	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.	Before and after the procedure, at 5 minutes.
Primary	stress ball and pain	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.	during the procedure
Secondary	Stress ball and blood pressure	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.	Before and after the procedure, at 3 minutes.
Secondary	Stress ball and pulse	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.	Before and after the procedure, at 3 minutes.
Secondary	Stress ball and saturation	The impact of using a stress ball during spinal anesthesia on saturation will be evaluated. It will be recorded in percentage.	Before and after the procedure, at 3 minutes.