Clinical trial NCT06267196: The Effect of the Stress Ball Used During Spinal Anesthesia on Pain and Anxiety
Official title: The Effect of the Stress Ball Used During Spinal Anesthesia on Pain and Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Anxiety
Keywords: Stress
Spinal anesthesia
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: stress ball and anxiety
timeFrame: Before and after the procedure, at 5 minutes.
measure: stress ball and pain
timeFrame: during the procedure
Secondary outcomes:
measure: Stress ball and blood pressure
timeFrame: Before and after the procedure, at 3 minutes.
measure: Stress ball and pulse
timeFrame: Before and after the procedure, at 3 minutes.
measure: Stress ball and saturation
timeFrame: Before and after the procedure, at 3 minutes.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Özge Sayın Ayan
state: Eyup
city: Istanbul
country: Turkey
facility: Prof.Dr.Cemil Tascioglu City Hospital
state: Şişli
Study officials:
References:
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.
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.
citation: 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.