About this trial
Intramuscular injection is one of the most common invasive procedures in childhood and is frequently associated with pain and fear. These negative experiences may affect children's attitudes toward healthcare and complicate nursing care. Therefore, using non-pharmacological methods is essential for promoting child-friendly services. This study aims to evaluate the effects of the Helfer Skin Tap and vibration techniques on pain and fear levels in children aged 5-10 years during intramuscular injections.
The study is designed as a parallel, three-arm randomized controlled trial conducted in the Pediatric Emergency Clinic of Ege University Hospital. Participants will be allocated by simple randomization to Helfer Skin Tap, vibration, or standard care. Sample size was calculated with G\*Power 3.1 using a repeated-measures within-between interaction model with two time points (T0-T1), α=0.05, and power=0.80. Assuming a medium effect size (f=0.25) based on previous studies, at least 159 children are required. Allowing for 15% attrition, the final sample will include 186 participants (62 per group).
Data will be collected using a Child Information Form including sociodemographic characteristics and prior injection experiences. A Procedure Record Form will document randomization, assigned group, medication, dose, injection site, duration, child's position, and parental presence.
Pain and fear will be assessed immediately before (T0) and after (T1) the injection. Pain will be measured with the Wong-Baker FACES Pain Rating Scale (0-10) and fear with the Children's Fear Scale (0-4). Ratings will be obtained independently from the child, parent, and observing nurse.
The procedure will be video-recorded to enable objective evaluation of behavioral responses. Recordings will be scored by an independent blinded expert using standardized criteria. Videos will be used only for research purposes, with identifying features concealed, stored in coded format, and destroyed after study completion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The child must be in the 5-10 age group
Intramuscular injection must be performed,
The child must be able to communicate in Turkish,
Verbal/written consent must be obtained from the parents/legal guardians
Disqualifiers
Known neurological disorders,
Inability to communicate cognitively,
Chronic pain syndrome
Acute and life-threatening clinical condition
Trial design
Parallel
Treatments tested in this trial
Helfer skin tab
Other interventionA rhythmic and light tapping technique will be applied to the injection site before and during intramuscular injection.
Vibration Buzzy Bee
DeviceShort-term vibration will be applied to the injection site prior to injection, and vibration will be maintained during injection.
Treatment groups
Trial outcomes
Primary outcomes
Fear level and incidence of intramuscular injections assessed by the Faces Scale for the Assessment of Anxiety
The results will be collected using the Faces Scale for the Assessment of Anxiety. This scale is intended to numerically determine the child's level of fear related to the procedure.
Pain level and incidence felt during intramuscular injection assessed by the Wong Baker Pain Scale
The results will be collected using the Wong Baker Pain Scale. This scale is intended to numerically determine the child's level of pain related to the procedure.
Sponsors and contacts
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