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

NCT07410910 | Completed

• 1 other identifier: MersinU*GUGUCU_005
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Newborns; Comfort in Neonates

Keywords

neonates; body weight measurement; comfort

Outcome Measures

Primary Outcomes (2)

• COMFORTneo scores during the procedure

  Turkis version of COMFORTneo consists of six behavioral items (alertness, calmness/agitation, respiratory response, crying, body movement, facial tension, and muscle tone), of which six items should be scored (respiratory response or crying depends on the presence of invasive ventilation). Each item has a score range of 1 to 5 and the total score ranges from 6 to 30. Higher values represent lower comfort.

  during the body weight measurement procedure

• COMFORTneo scores after the procedure

  Turkis version of COMFORTneo consists of six behavioral items (alertness, calmness/agitation, respiratory response, crying, body movement, facial tension, and muscle tone), of which six items should be scored (respiratory response or crying depends on the presence of invasive ventilation). Each item has a score range of 1 to 5 and the total score ranges from 6 to 30. Higher values represent lower comfort.

  2 minutes after the body weight measurement procedure

Secondary Outcomes (4)

• Heart rate during the procedure

  during the body weight measurement

• Heart rate after the procedure

  2 minutes after the body weight measurement

• Oxygen saturation during the procedure

  during the body weight measurement

• Oxygen saturation after the procedure

  2 minutes after the body weight measurement

Other Outcomes (1)

• Number of Participants with Adverse Events

  Within 5 minutes following the procedure

Study Arms (4)

Routine Care

ACTIVE COMPARATOR

Routine Care

Other: Routine Care

Holding

ACTIVE COMPARATOR

Holding

Other: Holding

Swaddling

ACTIVE COMPARATOR

Swaddling

Behavioral: Swaddling

Swaddling + Holding

ACTIVE COMPARATOR

Swaddling + Holding

Behavioral: Swaddling + Holding

Interventions

Routine Care OTHER

Resetting the scale, safely placing the newborn on the baby scale, weighing them, and removing them from the scale

Routine Care

Swaddling BEHAVIORAL

Swaddling: Swaddling the newborn using a safe technique, resetting the scale, safely placing the newborn on the baby scale, weighing them, and removing them from the scale.

Swaddling

Holding OTHER

Holding the baby: The parent safely holding the newborn, resetting the scale, weighing the newborn on the parent's lap on an adult scale, and then the parent stepping onto the adult scale and being weighed.

Holding

Swaddling + Holding BEHAVIORAL

Swaddling + Holding: Swaddling the newborn using a safe technique, the parent safely holding the newborn, resetting the scale, weighing the newborn on an adult scale while in the parent's arms, and only the parent stepping on the adult scale and being weighed.

Swaddling + Holding

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University Hospital

Mersin, Province, 33343, Turkey (Türkiye)

Location

Study Officials

• GUZIDE UGUCU, RN, MScN, PhD

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Res. Assist., RN, MScN, PhD

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 13, 2026
• Study Start: February 13, 2026
• Primary Completion: March 3, 2026
• Study Completion: March 3, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)