The Effect of Helfer Skin Tap and Vibration Techniques on Pain and Fear During Intramuscular Injection in Children Aged 5-12 Years in the Pediatric Emergency Department: A Randomized Controlled Trial

Intramuscular injection is one of the most frequently performed invasive procedures in childhood and is often associated with pain and fear. This situation can negatively affect children's healthcare experiences and cause difficulties for nurses in the care process. The use of non-pharmacological methods to reduce pain and fear is important for the development of child-friendly healthcare services. This project aims to evaluate the effect of the Helfer Skin Tap and vibration techniques used during intramuscular injections in children aged 5-10 years on the levels of pain and fear experienced by children.

The study was designed as a parallel, three-arm, randomized controlled experimental study at the Ege University Hospital Pediatric Emergency Clinic. Participants will be divided into three groups using simple random sampling; the first group will receive the Helfer Skin Tap technique, the second group will receive the vibration technique, and the third group will be the standard care control group. The sample size was calculated using the G*Power 3.1 program. Since the study involved three groups (Helfer Skin Tap, vibration, and control) and measurements at two time points (T0-T1), a 'within-between interaction' model was used for the analysis of variance for repeated measures. The Type I error level was set at α=0.05 and power (1-β)=0.80. Considering the effect sizes in similar intervention studies in the literature, a medium effect size (f=0.25) was assumed (Kurt et al., 2024). With these parameters, a total of at least 159 participants (approximately 53 children/group) are required. Considering possible losses, the sample size was planned to be 186 children (62 children/group) with a 15% increase. The Child Information Form, prepared by researchers in line with the relevant literature (Kurt et al., 2024), contains information on the children's sociodemographic characteristics (age, gender, height, weight, presence of other children in the family) and their experience with intramuscular injections (previous intramuscular injections, reactions to previous experiences). The Procedure Record Form will record randomization information, the study group to which the child was assigned (Helfer Skin Tap, vibration, or control), and technical information related to the injection (drug, dose, application site, procedure duration, child's position, and parent's presence during the procedure).

Children's pain and fear levels will be assessed at two time points: before the procedure (T0: immediately before the injection begins) and after the procedure (T1: immediately after the injection ends). Pain levels will be measured using the Wong-Baker FACES Pain Rating Scale (0-10 points), and fear levels will be measured using the Children's Fear Scale (CFS, 0-4 points). These assessments will be performed independently by the child, the parent, and the nurse observing the procedure.

Additionally, the intramuscular injection process will be video-recorded to objectively assess children's behavioral responses. The video recordings will be viewed by an expert evaluator who is not involved in the study and is unaware of the group assignments (blinded). The child's behavioral responses to pain and fear will be scored according to predefined standard evaluation criteria. Camera recordings will be used solely for scientific purposes; faces and identifying information will be concealed; recordings will be stored in coded form and will be destroyed after the study is completed.