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Clinical Trials/NCT06136130
NCT06136130
Completed
N/A

The Effect of Positioning With Material and Hand-Face Maneuver on Physiological Parameters and Stress Symptoms in Preterm Newborns

Kirsehir Ahi Evran University1 site in 1 country60 target enrollmentSeptember 1, 2018
ConditionsStressPosition

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stress
Sponsor
Kirsehir Ahi Evran University
Enrollment
60
Locations
1
Primary Endpoint
Newborn Position Assesment Tool
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The study was administered in a randomized controlled experimental design to evaluate the effects of material positioning and hand-face maneuver on physiological parameters and stress symptoms in preterm newborns with gestational weeks 28 to 32. The sample of the study consisted of 60 preterm infants who met the selection criteria in newborn intensive care unit between September 2018 and July 2020.The newborns in the control group (n=30) were given a "nesting with a rolled up blanket" position, as in the routine of the ward. The Experimental Group1 (n=30) was given positions using a "positioner" and the same newborns (Experimental2) was given positions using "positioner and hand-face maneuver" on the second day of the study.

Detailed Description

The universe of the study consisted of preterm newborns patients who met the selection criteria in newborn intensive care unit.The research was planned as a randomized controlled experimental study. In order for the groups to be distributed homogeneously, the order produced by a computer program (http://www.randomizer.org/) was used. Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list. The control variable of the study is demographic characteristics of the baby. The dependent variables of the study are physiological parameters, newborn position assesment tool score and newborn stress scale score In the research, "Information and follow-up form" prepared by the researcher in line with the literature was used as data collection tools. Newborn Position Assesment Tool and Newborn Stress Scale were also used

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
July 1, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kirsehir Ahi Evran University
Responsible Party
Principal Investigator
Principal Investigator

Isıl AR

Research Assistant

Kirsehir Ahi Evran University

Eligibility Criteria

Inclusion Criteria

  • Preterm newborn between 28-32 weeks of gestation (very early preterm)
  • Not connected to mechanical ventilator
  • Parent's consent with informed consent form

Exclusion Criteria

  • Presence of congenital anomalies, a known infection, neuromuscular problems and genetic anomalies in a preterm newborn
  • Have undergone any surgical intervention
  • Painful procedure (invasive procedure, etc.) performed in the last hour
  • Taking analgesics in the last six hours

Outcomes

Primary Outcomes

Newborn Position Assesment Tool

Time Frame: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position

The Infant Position AssessmentTool (IPAT) is a six-item(shoulders, hands, hips, knees,ankles, feet, head, neck) tool with cumulative scores ranging from 0 to 12. A scale score of 12 indicates that the position is given very well, and a score of 0 indicates that the position is very bad.

Newborn Stress Scale

Time Frame: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position

Scale items were collected in 8 subgroups. These subgroups consist of a total of 24 items in 3-point Likert type, including facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities, and posture.A minimum of 0 points and a maximum of 16 points are taken from the scale. As the score increases, the baby's stress level increases.

Respiratory rate assesment

Time Frame: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position

respiratory rate/min,

Pulse rate assesment

Time Frame: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position

Pulse rate/min

Oxygen saturation assesment

Time Frame: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position

Oxygen saturation %

Study Sites (1)

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