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

Sponsor
Atlas University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06146543
Collaborator
(none)
50
1
1
5.1
9.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Stress ball
N/A

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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Stress Ball During Lumbar Puncture in Neurological Patients the Effect of the Application on Anxiety Level
Actual Study Start Date :
Sep 29, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: neurology patients

Patients coming to the neurology clinic for lumbar puncture.

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.

Outcome Measures

Primary Outcome Measures

  1. STAI XT-1 State-Trait Anxiety Scale [up to 6 months]

    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.

Secondary Outcome Measures

  1. STAI XT-1 State-Trait Anxiety Scale [up to 6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University, Istanbul Faculty of Medicine Istanbul Turkey

Sponsors and Collaborators

  • Atlas University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dilek Baykal, Assistant Professor, Atlas University
ClinicalTrials.gov Identifier:
NCT06146543
Other Study ID Numbers:
  • 2135111
First Posted:
Nov 24, 2023
Last Update Posted:
Nov 24, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2023