CompletedNot Applicable

Effect of Two Non-pharmacological Method on Pain, Stress Procedure Duration in Newborn

Turkey (Türkiye)100 participantsStarted 2023-12-11

Plain-language summary

This study is planned as a prospective, single-blind, randomized controlled experimental study matched according to gestational age, gender, and birth weight, to determine the effects of local heat application and oral sucrose use during heel prick blood collection on pain, stress, procedure duration, and physiological parameters of newborns.

Who can participate

Age range

3 Days – 31 Days

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: * 38-42 weeks gestational age, * birth weight ≥ 2500 g, * stable vital signs, * no congenital anomalies, * no congenital illnesses at birth such as neonatal asphyxia, hemolytic status, metabolic disease, skin disease, patent ductus arteriosus (PDA), respiratory distress syndrome (RDS), and sepsis, * no intracranial hemorrhage, * not taking any medications other than antibiotics and vitamin supplements, * not fed or changed within 30 minutes before the heel prick, * not taking opioids or sedatives within 4 hours before the heel prick, * not undergoing any painful procedures at least one hour before the heel prick, * newborns whose mothers gave verbal and written informed consent Exclusion Criteria: * Newborns who exhibited signs of infection (gastroenteritis, sepsis, etc.) during the study, * Blood collection was not possible on the first attempt, * Newborns whose mothers wished to withdraw from the study

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

ALPS-Neo Pain and Stress Assessment Scale

Timeframe: 6 month

Newborn Infant Pain Scale (NIPS)

Timeframe: 6 month

Trial details

NCT IDNCT07125690

SponsorTC Erciyes University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-11

View on ClinicalTrials.gov More Neonatal Pain trials