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

NCT06146543 | Completed

• 1 other identifier: 2135111
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurologic Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• STAI XT-1 State-Trait Anxiety Scale

  up to 6 months

Study Arms (2)

neurology patients

EXPERIMENTAL

Patients coming to the neurology clinic for lumbar puncture.

Other: Stress ball

Control

NO INTERVENTION

The scale will be applied to the same patient group before and after lumbar puncture without intervention.

Interventions

Stress ball OTHER

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.

neurology patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Control group

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: November 24, 2023
• Study Start: October 1, 2023
• Primary Completion: August 22, 2024
• Study Completion: August 22, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)