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

NCT ID: NCT06146543

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-08-22

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 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.

Conditions

Neurologic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

neurology patients

Patients coming to the neurology clinic for lumbar puncture.

Group Type: EXPERIMENTAL

Stress ball

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atlas University

OTHER

Sponsor Role: lead

Responsible Party

Dilek Baykal

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul University, Istanbul Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2135111

Identifier Type: -

Identifier Source: org_study_id