CompletedNot Applicable

Infant Pain During Vaccination and Maternal Anxiety

Turkey (Türkiye)90 participantsStarted 2022-10-25

Plain-language summary

This research was planned to determine the effect of two different methods on infant pain during vaccination and mother anxiety.The study was planned as a randomized controlled trial. The universe of this research consists of parents and their babies who come to Hocabey Family Health Center in Erzincan Center to receive the hepatitis B dose between these dates according to the vaccination calendar. In this study, it is planned to apply shotblocker and lullaby.

Who can participate

Age range

1 Month – 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: * The child does not have a disorder in the cognitive developmental area. * It is time to apply the hepatitis B vaccine of the 6th month. * Parent giving consent to participate in the study voluntarily and for their child to participate. Exclusion Criteria: * The child has a disorder in the cognitive developmental area. * Failure to apply the 6th month hepatitis B vaccine. * Parent's voluntarily participating in the study and not giving consent for the child's participation.

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

Newborn Infant Pain Scale (NIPS)

Timeframe: 9 MONTHS

State Anxiety Inventory

Timeframe: 9 MONTHS

Trial details

NCT IDNCT05598372

SponsorAtaturk University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-13

View on ClinicalTrials.gov More Vaccine Reaction trials