Stress Ball During Lumbar Puncture the Effect of the Application on Anxiety Level

Neurologic Disorder Clinical Trial

Official title:

Stress Ball During Lumbar Puncture in Neurological Patients the Effect of the Application on Anxiety Level

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06146543
• Other study ID #: 2135111
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: June 2024
• Source: Atlas University
• Contact: Sevda Ozturk Erden
• Phone: 02124443439
• Email: sevdaerden36[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 3.1.7" program. The minimum sample size that would provide Type I margin of error (α): 0.05 and power of the test (1-β): 0.80 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 patient's free hand will be given an elastic ball that is large enough to hold in the palm of the hand and squeeze easily. He/she 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• -Being over 18 years old

• Volunteering to participate in the study

• Being able to read and write

• No problems in verbal communication

• Lumbar puncture procedure will be performed

Exclusion Criteria:

• - Do not come to the neurology clinic for any procedure other than lumbar puncture.

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurologic Disorder

Intervention

Other:
• Stress ball
Before the procedure begins, the patient's free hand will be given an elastic ball that is large enough to hold in the palm of the hand and squeeze easily. He/she 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.

Locations

Country	Name	City	State
Turkey	Istanbul University, Istanbul Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Atlas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	STAI XT-1 State-Trait Anxiety Scale	It will be used to evaluate the current state of anxiety. The scale has a total of 40 items, 20 of which measure state anxiety and 20 measure trait anxiety. In order to determine the behaviors and emotions of the individuals to whom the scale is applied, each item is evaluated with the options of 'not at all', 'somewhat', 'a lot', and 'completely'. An increase in the total score obtained from the scale indicates that the person's anxiety level is increasing.; When the patient comes to the clinic, he/she will be informed about the study his/her consent will be obtained, and then the scale will be filled out.	up to 6 months
Secondary	STAI XT-1 State-Trait Anxiety Scale	It will be used to evaluate the immediate anxiety state after the intervention. The scale has a total of 40 items, 20 of which measure state anxiety and 20 measure trait anxiety. In order to determine the behaviors and emotions of the individuals to whom the scale is applied, each item is evaluated with the options of 'not at all', 'somewhat', 'a lot', and 'completely'. An increase in the total score obtained from the scale indicates that the person's anxiety level is increasing.; After the lumbar puncture procedure is completed, the patient will be relieved by taking the ball from her hand and the scale will be filled.	up to 6 months