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

February 19, 2024 updated by: Özge Sayın Ayan, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
The aim is to determine the impact of the stress ball used during spinal anesthesia on pain and anxiety levels

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Eyup
      • Istanbul, Eyup, Turkey, 34065
    • Şişli
      • Istanbul, Şişli, Turkey, 34360
        • Recruiting
        • Prof.Dr.Cemil Tascioglu City Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stress ball group
The patient group in which a stress ball is used during spinal anesthesia.
Other: The use of a stress ball
The effect of the stress ball used during spinal anesthesia on pain and anxiety
No Intervention: The control group
The group that receives only standard spinal anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stress ball and anxiety
Time Frame: 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.
Before and after the procedure, at 5 minutes.
stress ball and pain
Time Frame: 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.
during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress ball and blood pressure
Time Frame: 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.
Before and after the procedure, at 3 minutes.
Stress ball and pulse
Time Frame: 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.
Before and after the procedure, at 3 minutes.
Stress ball and saturation
Time Frame: 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.
Before and after the procedure, at 3 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2023

Primary Completion (Estimated)

March 2, 2024

Study Completion (Estimated)

March 15, 2024

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CemilTascıogluERHO-AYAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share the individual participant data (IPD) from this study in two formats: an Excel spreadsheet containing detailed data sets and a PDF document summarizing the key findings. The data sharing is scheduled to occur three months after the completion of the study.

Data Types and Scope:

The Excel spreadsheet will encompass comprehensive participant data, covering all relevant variables collected during the study.

The PDF document will provide a concise summary of the study results, highlighting key outcomes and trends.

IPD Sharing Time Frame

Approximately 3 months after the completion of the study.

IPD Sharing Access Criteria

Access is granted only to individuals with appropriate authorization, such as researchers, healthcare professionals, or authorized personnel.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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