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

NCT07468227 | Not Yet Recruiting DMC

• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Fear

Keywords

pediatric emergency; intramuscular injection; Helfer Skin Tap; vibration; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

Study Arms (3)

Helfer Skin Tab

EXPERIMENTAL

Other: Helfer skin tab

Vibration

ACTIVE COMPARATOR

Device: Vibration Buzzy Bee

Control

NO INTERVENTION

Interventions

Helfer skin tab OTHER

A rhythmic and light tapping technique will be applied to the injection site before and during intramuscular injection.

Helfer Skin Tab

Vibration Buzzy Bee DEVICE

Short-term vibration will be applied to the injection site prior to injection, and vibration will be maintained during injection.

Vibration

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Childrens Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Merve GUMUS, Ph.D

  Ege University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve GUMUS, Ph.D

CONTACT

00902323115619; mervedalgic10@gmail.com

Seda ARDAHAN SEVGİLİ, Ph.D

CONTACT

00902323115572; sedardahan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Professor

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: March 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)