CompletedNot Applicable

The Effect of Four Different Methods Used During Body Weight Measurement in Newborns on Comfort and Physiological Variables

Turkey (Türkiye)96 participantsStarted 2026-02-13

Plain-language summary

The study, planned to be conducted in a single-center, parallel-armed, randomized experimental design, aims to determine the effect of four different methods (Routine Care, Holding, Swaddling, Swaddling + Holding) on comfort scores as the primary outcome and on heart rate (HR) and peripheral capillary oxygenation (SaPO2) as secondary outcomes. Research hypotheses Primary Hypothesis: H1/1: There is a difference between the mean comfort scores of the groups. Secondary Hypothesis: H1/2: There is a difference between the mean HR values of the groups. H1/3: There is a difference between the mean SaPO2 values of the groups.

Who can participate

Age range

0 Days – 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: * Body weight measurement is planned as part of follow-up at the Mersin University Hospital Newborn Follow-up Clinic, * The parent gives consent for the baby and themselves to participate in the study, * The parent's body weight is less than 100 kg, * The newborn's birth weight is 2500 g or more, * The newborn's gestational age at birth is less than 37 weeks, * The newborn's postnatal age is 28 days or less, * The newborn is physiologically stable Exclusion Criteria: * The newborn has undergone surgery, * The newborn has a genetic, metabolic, or congenital disorder, * The newborn has a neuroendocrine disorder, * The newborn's gestational age at birth is greater than 37 weeks, * The newborn's postnatal age is greater than 28 days.

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

COMFORTneo scores during the procedure

Timeframe: during the body weight measurement procedure

COMFORTneo scores after the procedure

Timeframe: 2 minutes after the body weight measurement procedure

Trial details

NCT IDNCT07410910

SponsorMersin University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-03

View on ClinicalTrials.gov More Healthy Newborns trials