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NOT YET RECRUITING
NCT07880496
NA

The Effect of ShotBlocker on Symptoms of Pain, Anxiety, and Cortisol Hormone Levels

Sponsor: Ataturk University

View on ClinicalTrials.gov

Summary

The aim of this study is to evaluate the effect of Shotblocker, administered during lumbar puncture, on patients' pain levels, anxiety levels, and cortisol levels (a physiological stress indicator). This randomized controlled trial aims to scientifically demonstrate the effectiveness of Shotblocker use in reducing pain and anxiety during and after the procedure, and its effect on the stress response, compared to standard practice.

Official title: The Effect of Shotblockers on Pain, Anxiety, and Cortisol Level Symptoms During Lumbar Puncture: A Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2026-10-15

Completion Date

2026-11-20

Last Updated

2026-10-19

Healthy Volunteers

No

Conditions

Interventions

OTHER

Intervention Group

Patients will receive routine monitoring, pharmacological treatment, and nursing care. Under aseptic precautions, lumbar puncture will be performed in all groups using a 25-gauge Quincke spinal needle at the L3-L4 or L4-L5 intervertebral space, with patients in the lateral position. In the ShotBlocker group, after skin preparation and draping, the sterilized ShotBlocker will be placed at the puncture site and firmly pressed for 10 seconds with the non-dominant hand. The spinal needle will then pass through its slit. Methylprednisolone and bupivacaine hydrochloride will be administered into the epidural space. Saliva samples will be collected before and after the procedure for cortisol measurement. Pain and anxiety will be assessed before and 10 minutes after lumbar puncture. The procedure will be performed by the same physician in all groups.

OTHER

Control

In our research, the "Personal Information Form" will be applied to the control group patients without any intervention other than the clinical protocol. "Visual Analog Scale" and "State Anxiety Scale" will be applied to the patients 10 minutes before the lumbar puncture procedure. Saliva samples will be collected from patients before and after the lumbar puncture, and the collected samples will be stored under appropriate laboratory conditions for measurement of cortisol level. 10 minutes after the procedure is completed, the pain and anxiety levels experienced will be re-evaluated with scales.