The Effect of the Side Kangaroo Position in Newborns Undergoing Noninvasive Mechanical Ventilation

Condition(s) studied

Investigational drug(s) / intervention(s)

Side kangaroo position group: An appropriate environment will be provided for the application to ensure the privacy of the mothers in this group. It will be placed diagonally on the newborn mother's bare chest. The baby's head will be positioned sideways between the mother's chest and collarbone. Before, during, and 30 minutes after the procedure, the babies' comfort level, oxygen saturation, heart rate, and respiratory rate will be recorded.

Study summary

Aim:The study was designed as a randomized controlled trial to determine the effect of the side kangaroo position on comfort and physiological parameters in newborns receiving noninvasive mechanical ventilation. Method: The study will be conducted between February 2026 and July 2026 at Mersin University Faculty of Medicine Hospital, Neonatal Intensive Care Unit, with infants receiving nCPAP. Newborns scheduled to receive nCPAP will be divided into two groups (Side Kangaroo Position Group: 48, Control Group: 48), comprising a total of 92 newborns. Prior to the procedure, infants will be placed in the side kangaroo position on their mothers' chests; the control group will receive routine clinical care. Infants will be assessed using an "information form" and the "Newborn Comfort Behavior Scale." Vital signs will also be recorded before and after the procedure.

Eligibility

Primary outcome measure(s)

• Information Form — 1 day
  The information form was prepared by reviewing the relevant literature (Kaplan Laço, 2024; Göktürk, 2024) and consists of 11 questions regarding the newborn's gestational age, gender, diagnosis, height, weight, and mode of delivery.
• Newborn Comfort Behavior Scale — 1 day
  The comfort scale developed by Ambuel and colleagues in 1992 was adapted by Van Dijk and colleagues in 2009 as the COMFORTneo scale for patients receiving mechanical ventilator support in the pediatric intensive care unit, and reliability and validity studies were conducted. This scale aims to measure only behavioral parameters without considering the physiological indicators of newborns. The Turkish validity and reliability analysis of the COMFORTneo scale, designed to determine the distress levels of pediatric patients, was conducted by Kahraman and colleagues in 2014. This scale is a Likert-type scale developed to assess the comfort levels and pain and distress estimates of infants monitored in the neonatal intensive care unit. The scale includes a total of seven parameters: muscle tone, alertness, facial tension, calmness or agitation, body movements, respiratory response, and crying. The measurement results in a minimum score of 6 and a maximum sco
• Vital Signs Monitoring Form — 1 day
  A patient-side monitor, routinely used in neonatal intensive care settings, will be employed to measure physiological parameters such as pulse, respiration, and oxygen saturation before, during, and after the procedure for newborns participating in the study. The device consists of a monitor, power cord, skin temperature probe, ECG cable, blood pressure cuff (4 different sizes), and oxygen saturation probe. The data obtained is displayed on the device's LCD screen, and measurements can be recorded. Before application, during application, and 30 minutes after application, the babies' oxygen saturation, heart rate, and respiratory rate will be recorded.

Trial sites (1)

More Tarsus University trials in Turkey

Other trials for the same condition