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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06267196
Acronym
stressball
Enrollment
140
Registered
2024-02-20
Start date
2023-11-02
Completion date
2024-03-15
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pain

Keywords

Stress, Spinal anesthesia

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.

Interventions

OTHERThe use of a stress ball

The effect of the stress ball used during spinal anesthesia on pain and anxiety

Sponsors

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
stress ball and anxietyBefore 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.
stress ball and painduring the procedureEvaluating 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.

Secondary

MeasureTime frameDescription
Stress ball and blood pressureBefore 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 pulseBefore 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 saturationBefore 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactÖzge Sayın Ayan
ozgesayinayan@gmail.com+905332965628
Backup ContactVolkan Özen
vozen81@gmail.com+905309276094

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026