The Effect of a Multimodal Approach on Pain, Fear, and Anxiety in Injection Experiences in Children (Randomized)

THE EFFECT OF A MULTIMODAL APPROACH ON PAIN, FEAR, AND ANXIETY IN INJECTION EXPERIENCES

Reducing the pain and fear experienced by children during IM injections, one of the painful procedures commonly seen in emergency departments, is an important midwifery/nursing intervention. The authority of midwives and nurses to use non-pharmacological methods in IM injection administration, which is the most frequent procedure they perform, is expressed in the competency regulations of midwives and nurses. Considering the nature of pediatric emergency units, midwives/nurses increase the comfort of children and even parents by using practical, fast-acting, and low-cost methods that can be easily applied in such painful procedures. To reduce pain and fear during IM injections in children, it is important to both contribute to the literature on the positive effects of non-pharmacological methods in different age groups and to make the use of evidence-based low-cost practices a culture in the units we work in. The aim of the study is to investigate the effects of Buzzy® and HSTT on the pain and fear experienced by children aged 4-6 years during IM injections in pediatric emergency departments.

Study Overview

• Status: Completed
• Conditions: Children; Respiration Disorder
• Intervention / Treatment: Other: Injection

Detailed Description

Children in the control group of the study will receive IM injection, which is a routine procedure of the clinic. Children in the intervention group will receive HSTT and Buzzy® application as recommended by the literature. The Questionnaire, Wong Baker Faces Scale, and Child Fear Scale will be used to collect data. The Fear Scale will be administered by the researcher before the IM application, and the Pain and Fear Scales will be administered one minute and five minutes after the procedure. Buzzy® is designed in the shape of a bee and is visually appealing to children. It helps to block the transmission of painful stimuli through vibration. Cold Pack (Ice Wings): It is placed under the device and contacts the application area. Cold reduces the sensation of pain by slowing nerve transmission. The ice pack is frozen in the freezer and placed in the device. Buzzy® is applied to the injection area approximately 1-2 minutes beforehand. The device remains switched on during the procedure.Helfer Skin Tap Technique:

After determining the injection site, gently tap the skin several times with the fingertips of the dominant (most frequently used) hand for approximately 5 seconds to relax the muscle. After wiping and stretching the skin with antiseptic solution, open the cap of the syringe in the dominant (most frequently used) hand. Make a large V shape with the thumb and index finger of the non-dominant hand. Tap the skin three times quickly using the whole hand to stimulate the large muscle fibers. The nurse/midwife counts to 3 and the needle is simultaneously inserted into the muscle at a 90-degree angle. To remove the needle from the skin, tap the skin three times quickly (again in a V shape) with the whole non-dominant hand and withdraw the needle simultaneously with the final tap.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Sakarya, Turkey (Türkiye)
    • Sakarya University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The child must be in the 4-6 age group,
• The IM medication must be ordered by a doctor,
• The IM administration must be performed in the pediatric emergency department,
• The child must not have a disease causing chronic pain,
• The child must not have a neurodevelopmental disorder,
• The child must not have received analgesics in the last 6 hours,
• The child must not have a history of fainting during injection,
• The child must not have mental retardation,
• The child must not have scar tissue or muscle atrophy at the injection site,
• The child's percentile must be between 10th and 90th,
• The families and children must agree to participate in the study.

Exclusion Criteria:

• -Being younger than 4 years old,
• Being older than 6 years old,
• Having scarring or muscle atrophy at the injection site,
• Having communication problems in the child or parent,
• Having a percentile below 10 (cachectic) or above 90 (obese),
• Families and children not agreeing to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Control
Experimental: intervention group (helper skin tap); helper skin tap	Other: Injection; Injetion type
Experimental: intervention group (Buzzy); Buzzy®	Other: Injection; Injetion type

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Rating Scale	The Wong-Baker FACES Pain Rating Scale was used to assess self-reported pain levels. This scale consists of six facial expressions ranging from "no hurt" (0) to "hurts worst" (10), allowing children to select the face that best represents their level of pain.	12 week
Fear Scale	The Children's Fear Scale was used to assess the child's level of fear. This visual scale consists of five facial expressions depicting increasing levels of fear (scores range from 0 to 4). from neutral expression (0=no anxiety) to frightened face (4=severe anxiety)	12 week

Collaborators and Investigators

• Sponsor: Sakarya University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Actual): July 15, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: March 28, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: pain; children; fear; enjection
• Additional Relevant MeSH Terms: Neurologic Manifestations; Respiratory Tract Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Respiration Disorders; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: Rabia Yılmaz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Ethically, patient information can be shared upon reasonable request without revealing their identities for security reasons.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No