Clinical Trial

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

Completed
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-02-07; most recent amendment 2026-03-03.
Status change: Recruiting → Completed 2026-03-03
Status change: Not Yet Recruiting → Recruiting 2026-02-12
Trial Details
NCT Number NCT07410910
Lead Sponsor Mersin University
Conditions Healthy Newborns, Comfort in Neonates
Enrollment 96 participants
Start Date 2026-02-13
Primary Completion 2026-03-03 (estimated)
Study Completion 2026-03-03 (estimated)
Updated on ClinicalTrials.gov 2026-03-05