Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06146543
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2023-11-11
Brief Title:
Stress Ball During Lumbar Puncture the Effect of the Application on Anxiety Level
Sponsor:
Atlas University
Organization:
Atlas University
Study Overview
Official Title:
Stress Ball During Lumbar Puncture in Neurological Patients the Effect of the Application on Anxiety Level
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Individuals who come to the neurology clinic to undergo lumbar puncture and meet the inclusion criteria and agree to participate in the study will be given a stress ball during the procedure and will be asked to squeeze this ball
Detailed Description:
Before starting the research the purpose of the research will be explained to patients who meet the inclusion and exclusion criteria and their verbal and written consent will be obtained The Declaration of Helsinki will be adhered to throughout the research Data will be obtained by administering face-to-face surveys The population of the study will be individuals who meet the inclusion criteria at the neurology clinic of Istanbul University - Istanbul Faculty of Medicine and the individuals who agree to participate in the study will constitute the sample To determine the number of samples a comparison of two groups was made using the G-Power 317 program The minimum sample size that would provide Type I margin of error α 005 and power of the test 1-β 080 was determined as 47 people in total Taking into account sample loss it was aimed to reach a total of 50 people
Then the form questioning socio-demographic information and the STAI XT State-Trait Anxiety Scale will be applied Before the LP begins the patients free hand will be given an elastic ball that is large enough to hold in the palm of the hand and squeeze easily Heshe will be asked to squeeze this ball slowly throughout the process At the end of the procedure the ball will be removed from his hand and the patient will be relieved After the patient is relaxed the STAI XT State-Trait Anxiety Scale will be administered again
The state anxiety scale is a sensitive scale for evaluating sudden changes in emotional reactions The trait anxiety scale aims to measure the continuity of anxiety that a person generally tends to experience Since this study aims to evaluate the anxiety levels of patients regarding their current situations the state anxiety scale will be used
Then the form questioning socio-demographic information and the STAI XT State-Trait Anxiety Scale will be applied Before the LP begins the patients free hand will be given an elastic ball that is large enough to hold in the palm of the hand and squeeze easily Heshe will be asked to squeeze this ball slowly throughout the process At the end of the procedure the ball will be removed from his hand and the patient will be relieved After the patient is relaxed the STAI XT State-Trait Anxiety Scale will be administered again
The state anxiety scale is a sensitive scale for evaluating sudden changes in emotional reactions The trait anxiety scale aims to measure the continuity of anxiety that a person generally tends to experience Since this study aims to evaluate the anxiety levels of patients regarding their current situations the state anxiety scale will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None