CompletedNot Applicable

The Effect of Mother's Smell and Breast Milk Smell on Pain

Turkey (Türkiye)90 participantsStarted 2024-03-14

Plain-language summary

The research was planned as a randomized controlled study to investigate the effect of breast milk smell and mother's smell applied while heel blood was taken to term babies in the Mersin City EAH Neonatal Intensive Care Unit between October and December 2023, on acute pain and crying duration. During the heel prick procedure, which is routinely performed in the neonatal intensive care unit, no pharmacological/non-pharmacological method will be applied to the control group to reduce the baby's pain before, during and after the heel prick. The baby's pain score will be evaluated by the observing nurse according to the NIPS pain scale 5 minutes before, during and 5 minutes after the procedure. In the study group that will be made to smell the mother's scent; The mother of each baby whose heel blood will be taken will be given a specially made cover made of 100% cotton yarn, sterilized the day before, and the mother will be asked to put the cover on her bare skin (on her bare skin) after the shower and to keep the cover on the mother's chest for one night (8 hours). It will be placed 15 cm away from the baby and smelled 5 minutes before and 5 minutes after the heel prick attempt. The baby's pain score will be evaluated by the observing nurse according to the NIPS pain scale 5 minutes before, during and 5 minutes after the procedure.

Who can participate

Age range

1 Day – 15 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: * Term newborns receiving treatment in Mersin City Training and Research Hospital Neonatal Intensive Care Service, * Postnatal 1-15. Newborns on their day, * Newborns who have not previously used any pharmacological or non-pharmacological method for pain management, * Newborns with an Apgar score of 8 points or more at the 1st and 5th minutes, * Not having undergone a surgical procedure, * Does not have any health problems, * Patients whose families approve the informed consent form. Exclusion Criteria: * Born before 37 weeks of gestation, receiving treatment in the Neonatal Intensive Care Service at Mersin City Training and Research Hospital, * Sedation area * Except for major congenital anomaly * Older than the 15th postnatal day, * Having a major anomaly or disease detected antenatally, * Patients with comorbid diseases such as perinatal asphyxia, bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, congenital heart disease and similar diseases, * Patients whose families do not give consent will not be included in 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

Neonatal Infant Pain Scale

Timeframe: 1 day

Trial details

NCT IDNCT06323551

SponsorTarsus University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-23

View on ClinicalTrials.gov More Newborn; Vitality trials