NCT07509164|Completed
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
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Randomized
THE EFFECT OF A MULTIMODAL APPROACH ON PAIN, FEAR, AND ANXIETY IN INJECTION EXPERIENCES
Sponsor study identifier
interventional
120
1 country
1
Study Start
July 15, 2025
Actual (reported)Primary Completion
July 15, 2025
Actual (reported)Study Completion
July 30, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 30, 2025
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 15, 2025
Actual (reported)July 15, 2025
Actual (reported)July 30, 2025
Actual (reported)December 28, 2025
Actual (reported)April 3, 2026
Actual (reported)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
helper skin tap
Buzzy®
Control
Injetion type
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sakarya University
Sakarya, Turkey (Türkiye)
120 participants (actual enrollment reported by the registry).
First Submitted
December 28, 2025
First Posted
April 3, 2026
Study Start
July 15, 2025
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 15, 2025
Actual (reported)Study Completion
July 30, 2025
Actual (reported)Last Updated
April 3, 2026
Record last verified: 2026-03
Ethically, patient information can be shared upon reasonable request without revealing their identities for security reasons.
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Source: ClinicalTrials.gov.
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