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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-02

Study Completion Date

2024-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Hand Holding and Stress Ball Intervention on Pain and Anxiety

NCT07108192

Cataract Surgery

NOT_YET_RECRUITING NA

The Effect of Preoperative Anxiety on Duration and Efficacy of Motor and Sensory Block in Spinal Anesthesia

NCT03958578

Anxiety

COMPLETED

Effect of Stress Ball During Chest Tube Removal After Open Heart Surgery

NCT07251270

Pain Hemodynamic Changes Anxiety

RECRUITING NA

Regional Anesthesia / Peripheral Nerve Block and General Anesthesia on Preoperative Anxiety

NCT02511210

Anxiety Disorders

UNKNOWN NA

The Effect of Breathing Exercise Applied With Incentive Spirometer

NCT06507163

Breathing Exercises Cardiac Surgery Incentive Spirometry

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stress ball group

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

Group Type ACTIVE_COMPARATOR

The use of a stress ball

Intervention Type OTHER

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

The control group

The group that receives only standard spinal anesthesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The use of a stress ball

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes