Clinical trial NCT06146543: Stress Ball During Lumbar Puncture the Effect of the Application on Anxiety Level
Official title: Stress Ball During Lumbar Puncture in Neurological Patients the Effect of the Application on Anxiety Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurologic Disorder
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Control group
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: STAI XT-1 State-Trait Anxiety Scale
timeFrame: up to 6 months
Secondary outcomes:
measure: STAI XT-1 State-Trait Anxiety Scale
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Istanbul Faculty of Medicine
Study officials:
References: