CompletedNot Applicable

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

Turkey (Türkiye)120 participantsStarted 2025-07-15

Plain-language 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.

Who can participate

Age range

4 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Rating Scale

Timeframe: 12 week

Fear Scale

Timeframe: 12 week

Trial details

NCT IDNCT07509164

SponsorSakarya University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-15

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