NCT07509164

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Sakarya University · Academic / Other
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Children
• Respiration Disorder

Interventions

Type	Name	Description
OTHER	Injection	Injetion type

Timeline

• Start date: 2025-07-15
• Primary completion: 2025-07-15
• Completion: 2025-07-30
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: Turkey (Türkiye)