Effect of Vibration and ShotBlocker on Pain and Fear Levels During Intramuscular Injection in Children in the Emergency Department

Emergency departments are among the clinical areas where invasive procedures frequentlyencountered by children are performed. Intramuscular injections are one of the mostcommon procedures performed on children in the emergency department, and they can causepain and fear, leading to negative experiences for children. In the literature, it isstated that nurses should use pharmacological and non‐pharmacological methods in pain andfear management in painful procedures. Evidence‐based studies are needed to show theeffectiveness of non‐pharmacological methods in reducing pain during invasive proceduresand to investigate the effects of easy‐to‐apply methods on pain.This prospective study is planned as a randomized controlled study. The aim of this studyis to investigate the effects of vibration and the ShotBlocker method on pain and fearlevels in children during intramuscular injection in the emergency department.The study will be conducted in three groups (Vibration, ShotBlocker, and Control), and atotal of 120 children will be enrolled, with 40 participants in each group. The primaryoutcome will be pain intensity. The sample size was determined using an a priori poweranalysis performed with G*Power version 3.1.9.7. The calculation was based on a one‐wayanalysis of variance (ANOVA) with three groups, an alpha level of 0.05, 80% statisticalpower (1‐β = 0.80), and a Cohen's effect size (f) of 0.30. The analysis indicated that aminimum of 111 participants would be required. Considering potential participantattrition and missing data, the sample size was increased to 120 participants, with 40children allocated to each group (Vibration Group, n = 40; ShotBlocker Group, n = 40; andControl Group, n = 40).Data were collected through face‐to‐face interviews using three forms: the "DataCollection Form," the "Wong‐Baker FACES Pain Scale," and the "Children's Fear Scale."Data Collection: Before starting the study, parents of children meeting the sampleselection criteria will be briefly informed about the purpose of the study, and writtenconsent will be obtained for their participation. Then, data collection tools will beadministered. Forms will be collected through face‐to‐face interviews. After a child isselected, the nurse working at the institution will administer the intramuscularinjection to the child, while routine injections will be given to the control groupchildren. No intervention will be performed. The nurse will apply vibration to thevibration group children. In the vibration group, vibration will begin 30 seconds beforethe injection, and no vibration will be applied during the 10‐second waiting phase whilethe nurse performs the intramuscular injection. In the shotblocker group children, thenurse will position the device between the injection site and the heel prick bloodsample.Shotblocker: This is a plastic device. No needle is inserted into the patient. Theresearcher will monitor the child's pain and fear levels during this time. Parents andobservers will be asked to rate their fear/anxiety levels on the CFS scale before,during, and after the procedure, while children will be asked to do the same before andafter. The child's post‐procedure pain level (WB‐FACES scale) will be assessed by thechild themselves, as well as by the parent and observer. The scales will be evaluatedindependently and simultaneously, and the results will be recorded on a form.No invasive procedure will be performed on the child. All these procedures will takeapproximately 5‐10 minutes.