Effect of Helfer Skin Tap and Vibration on Pain and Fear in Children During Intramuscular Injection

Sponsor
Ege University
Study ID
NCT07468227
Status
Not Yet Recruiting

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Conditions

  • Fear
  • Pain

Eligibility Criteria

Sex
ALL
Age
5 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Helfer skin tab — OTHER
    A rhythmic and light tapping technique will be applied to the injection site before and during intramuscular injection.
  • Vibration Buzzy Bee — DEVICE
    Short-term vibration will be applied to the injection site prior to injection, and vibration will be maintained during injection.

Study Details

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.

Key Dates

First listed
Mar 12, 2026
Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Dec 1, 2026
Completion
May 1, 2027

Study Design

Enrollment
186 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Helfer Skin Tab
  • Active Comparator: Vibration
  • No Intervention: Control

Primary Outcome Measure

Fear level and incidence of intramuscular injections assessed by the Faces Scale for the Assessment of Anxiety [ Time Frame: Immediately before the injection begins, Immediately after the injection ends ]

Central Contacts

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