CompletedNot Applicable

Non-Pharmacological Methods in Reducing Injection Pain

Turkey (Türkiye)120 participantsStarted 2025-12-25

Plain-language summary

In emergency departments, various methods can be used to reduce the pain experienced by children. However, the most important requirement is that the selected method provides rapid and effective results. Accordingly, it is essential that interventions performed in emergency settings are carried out in a way that enables children to experience the least possible pain and anxiety and that the long-term effects of pain are prevented. Recently, the Helfer Skin Tap Technique (HSTT), which is applied to reduce stress and pain, and the palm stimulator, which is held in the palm and has raised projections on its surface to reduce pain perception by facilitating distraction, have attracted attention. ShotBlocker is a noninvasive, U-shaped plastic device with small projections that is used to reduce injection-related pain in children who are sensitive to pain. In addition, a bee-shaped device called Buzzy®, which combines external cold application and vibration, is also widely used. These methods have been proven to be effective in reducing pain in pediatric patients during invasive procedures such as intramuscular injections and intravenous cannulation.

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: * Children aged between 4 and 6 years, * An intramuscular (IM) medication order was prescribed by a physician, * The IM injection was administered in the pediatric emergency department, * No history of chronic pain-causing illness, * No diagnosis of neurodevelopmental disorders, * Had not received any analgesic medications in the past 6 hours, * No history of syncope (fainting) during previous injections, No diagnosis of mental retardation, * No scar tissue or muscle atrophy at the intended injection site, * Body mass index (BMI) percentile between the 10th and 90th percentiles for age and gender, * Both child and parent provided informed consent to participate in the study. Exclusion Criteria; * Participants were excluded from the study if: * The child was younger than 4 or older than 6 years, * There was scar tissue or muscle atrophy at the injection site, * The child or parent had communication difficulties, * The child's BMI was below the 10th percentile (cachectic) or above the 90th percentile (obese), * Either the child or parent declined to participate in the research.

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: 6 weeks

Trial details

NCT IDNCT07367659

SponsorSakarya University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-15

View on ClinicalTrials.gov More Pain trials