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

March 11, 2026 updated by: SEDA ARDAHAN SEVGİLİ, Ege University

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 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Known neurological disorders,
  • Inability to communicate cognitively,
  • Chronic pain syndrome
  • Acute and life-threatening clinical condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Helfer Skin Tab
Other: Helfer skin tab
A rhythmic and light tapping technique will be applied to the injection site before and during intramuscular injection.
Active Comparator: Vibration
Device: Vibration Buzzy Bee
Short-term vibration will be applied to the injection site prior to injection, and vibration will be maintained during injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Immediately before the injection begins, Immediately after the injection ends
Pain level and incidence felt during intramuscular injection assessed by the Wong Baker Pain Scale
Time Frame: Immediately before the injection begins, Immediately after the injection ends
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.
Immediately before the injection begins, Immediately after the injection ends

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Principal Investigator: Merve GUMUS, Ph.D, Ege University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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