CompletedNot Applicable

Paternal vs Maternal Holding-Cuddling for Procedural Pain in Healthy Term Neonates

Turkey (Türkiye)92 participantsStarted 2016-02-04

Plain-language summary

This study investigated the effect of maternal holding-cuddling (MHC) and paternal holding-cuddling (PHC) on heel prick pain and crying duration in healthy term neonates

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: * healthy term neonates * birth weight between 2500 and 4000 g * 38-42 gestational week * postnatal age of 48-72 hours * a 5-minute APGAR score of ≥8, * having had no experience of any painful interventions other than vitamin K and hepatitis B vaccine at birth * fed between 30 and 60 min before the procedure * undergoing heel prick only once * blood collection for the Guthrie test * willing to hold their babies during the procedure Exclusion Criteria: * sleeping during the procedure * receiving analgesics up to 24 hours before the procedure

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

Neonatal Infant Pain Scale (NIPS)

Timeframe: Through painful procedure completion, an average of 10 minutes

Trial details

NCT IDNCT06111534

SponsorIstanbul Medeniyet University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08-20

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.