CompletedNot Applicable

Breast Milk Odor on the Pain and Stress Level of the Newborn Endotracheal Aspiration Procedure

Turkey (Türkiye)88 participantsStarted 2022-03-19

Plain-language summary

Our study aims to determine the effect of breast milk odor on pain and stress in the application of endotracheal aspiration in newborns hospitalized in the Neonatal Intensive Care Unit. The research is planned experimentally with a pretest posttest randomized control group. The research will be carried out in Şanlıurfa Training and Research Hospital Neonatal Intensive Care Unit between March-December 2022. The population of the study will consist of patients aged 30-28 days who were hospitalized in the Şanlıurfa Training and Research Hospital Neonatal Intensive Care Unit between March-December 2022 and received mechanical ventilation treatment. The research sample; Babies of families who are hospitalized on the dates specified with the probability sampling method and meet the research criteria and volunteer to participate in the research will be formed. Questionnaire Form, Neonatal Pain and Stress Assessment Scale, and Follow-up Form will be used to collect research data. The scent of breast milk will be used as an intervention tool in the research.

Who can participate

Age range

1 Day – 28 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: * Being a term newborn, * to be between 0-28 days, * Receiving mechanical ventilation support, * Not taking opioids or sedatives 4 hours before the procedure. Exclusion Criteria: * not be between 0-28 days, * Not receiving mechanical ventilation support, * Taking opioids or sedatives 4 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

ALPS Neo Neonatal Pain and Stress Rating Scale

Timeframe: 9 MONTHS

Trial details

NCT IDNCT05331846

SponsorAtaturk University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-27

View on ClinicalTrials.gov More Endotracheal Aspiration trials