The Effect of Vibration and ShotBlocker on Pain and Fear Levels During Intramuscular Injection in Children in the Emergency Department: A Randomized Controlled Trial

Emergency departments are among the clinical areas where invasive procedures frequently encountered by children are performed. Intramuscular injections are one of the most common procedures performed on children in the emergency department, and they can cause pain and fear, leading to negative experiences for children. In the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and fear management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and 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 study is to investigate the effects of vibration and the ShotBlocker method on pain and fear levels in children during intramuscular injection in the emergency department.

The study will be conducted in three groups (Vibration, ShotBlocker, and Control), and a total of 120 children will be enrolled, with 40 participants in each group. The primary outcome will be pain intensity. The sample size was determined using an a priori power analysis performed with G*Power version 3.1.9.7. The calculation was based on a one-way analysis of variance (ANOVA) with three groups, an alpha level of 0.05, 80% statistical power (1-β = 0.80), and a Cohen's effect size (f) of 0.30. The analysis indicated that a minimum of 111 participants would be required. Considering potential participant attrition and missing data, the sample size was increased to 120 participants, with 40 children allocated to each group (Vibration Group, n = 40; ShotBlocker Group, n = 40; and Control Group, n = 40).

Data were collected through face-to-face interviews using three forms: the "Data Collection Form," the "Wong-Baker FACES Pain Scale," and the "Children's Fear Scale." Data Collection: Before starting the study, parents of children meeting the sample selection criteria will be briefly informed about the purpose of the study, and written consent will be obtained for their participation. Then, data collection tools will be administered. Forms will be collected through face-to-face interviews. After a child is selected, the nurse working at the institution will administer the intramuscular injection to the child, while routine injections will be given to the control group children. No intervention will be performed. The nurse will apply vibration to the vibration group children. In the vibration group, vibration will begin 30 seconds before the injection, and no vibration will be applied during the 10-second waiting phase while the nurse performs the intramuscular injection. In the shotblocker group children, the nurse will position the device between the injection site and the heel prick blood sample.

Shotblocker: This is a plastic device. No needle is inserted into the patient. The researcher will monitor the child's pain and fear levels during this time. Parents and observers 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 and after. The child's post-procedure pain level (WB-FACES scale) will be assessed by the child themselves, as well as by the parent and observer. The scales will be evaluated independently and simultaneously, and the results will be recorded on a form.