CompletedNot Applicable

The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates

Turkey (Türkiye)108 participantsStarted 2022-11-10

Plain-language summary

This study was conducted to determine the effect of mechanical vibration and ShotBlocker methods on pain level, crying time and procedure time during heel prick blood collection in healthy term infants.

Who can participate

Age range

38 Weeks – 42 Weeks

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: * with a postnatal age of 24-72 hours, * birth weight of 2500 g and above, * 5th minute APGAR score above 6, * able to carry out vital activities without support, * fed within one hour before the procedure, * calm and not crying before the procedure, * babies who had heel prick for the first time Exclusion Criteria: * with genetic or congenital anomaly, * with neurological, cardiological and metabolic diseases, * in need of respiratory support, * having a history of sedative, analgesic, or narcotic use within 24 h before admission, * hospitalization and surgical procedure experience in neonatal intensive care unit, * experience with needle interventions other than vitamin K and Hepatitis B vaccine, * babies of mothers with a history of substance abuse

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

Procedural pain score- Neonatal Infant Pain Scale (NIPS)

Timeframe: 1 min before the heel lance procedure (T-1 min), during the procedure (T+0 sec), 2 min (T+2 min) and 5 min (T+5 min) after the procedure; an average of 6 minutes

Trial details

NCT IDNCT06380556

SponsorIstanbul Medeniyet University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-30

View on ClinicalTrials.gov More Procedural Pain trials

Who can participate

Age range

38 Weeks – 42 Weeks

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.