This randomized controlled trial aims to evaluate the effectiveness of two non-pharmacological methods-white noise and the Buzzy device-in reducing pain experienced by infants during routine vaccination. Infants are known to feel pain, and untreated or poorly managed pain during early life may lead to negative short- and long-term outcomes. Therefore, identifying effective, safe, and easy-to-apply pain-reducing strategies is essential for improving infant comfort and supporting evidence-based nursing practices.
Who can participate
Age range
2 Months – 6 Months
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
* Infants aged 2 to 6 months
* Receiving routine hexavalent vaccination
* Born at term (≥37 weeks gestation)
* Medically stable at the time of vaccination
* Parent or legal guardian able to provide written informed consent Exclusion Criteria
* Infants with neurological disorders or developmental delay
* Use of analgesic, antipyretic, or sedative medications within 24 hours prior to vaccination
* Skin conditions or contraindications at the injection site
* Hearing impairment that may affect response to white noise
* History of adverse reactions to vaccination
* Preterm infants (\<37 weeks gestation)
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.