The Effect of the Stress Ball Used During Spinal Anesthesia on Pain and Anxiety
stressball
1 other identifier
interventional
140
1 country
2
Brief Summary
The aim is to determine the impact of the stress ball used during spinal anesthesia on pain and anxiety levels
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Nov 2023
Shorter than P25 for not_applicable pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 2, 2023
CompletedFirst Submitted
Initial submission to the registry
December 14, 2023
CompletedFirst Posted
Study publicly available on registry
February 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2024
CompletedFebruary 20, 2024
February 1, 2024
4 months
December 14, 2023
February 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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 Outcomes (3)
Stress ball and blood pressure
Before and after the procedure, at 3 minutes.
Stress ball and pulse
Before and after the procedure, at 3 minutes.
Stress ball and saturation
Before and after the procedure, at 3 minutes.
Study Arms (2)
Stress ball group
ACTIVE COMPARATORThe patient group in which a stress ball is used during spinal anesthesia.
The control group
NO INTERVENTIONThe group that receives only standard spinal anesthesia
Interventions
The effect of the stress ball used during spinal anesthesia on pain and anxiety
Eligibility Criteria
You may qualify if:
- Patients aged 18 and above.
- Patients with cesarean category 3 and 4.
You may not qualify if:
- Patients under the age of 18
- Patients undergoing emergency cesarean section
- Patients with bleeding disorders
- Individuals with psychological disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Özge Sayın Ayan
Istanbul, Eyup, 34065, Turkey (Türkiye)
Prof.Dr.Cemil Tascioglu City Hospital
Istanbul, Şişli, 34360, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 30027283BACKGROUNDKumar 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.
PMID: 26885298BACKGROUNDHudson 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.
PMID: 25641687RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 14, 2023
First Posted
February 20, 2024
Study Start
November 2, 2023
Primary Completion
March 2, 2024
Study Completion
March 15, 2024
Last Updated
February 20, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- Approximately 3 months after the completion of the study.
- Access Criteria
- Access is granted only to individuals with appropriate authorization, such as researchers, healthcare professionals, or authorized personnel.
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.