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 range0 Days – 28 Days

SexALL

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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.

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