The Effect of Positioning With Material and Hand-Face Maneuver

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

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.

Study Overview

• Status: Completed
• Conditions: Stress; Position
• Intervention / Treatment: Device: Tortoise Positioning Material Group

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey, 34381
    • Kocaeli University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positioning Material; Preterm infants in Intervention group were placed in the nest with positioning material and placed in lateral and prone positions The positioning material and hand-face maneuver were applied together to the preterm infants in the intervention group, and they were given lateral and prone positions in this way in the second day	Device: Tortoise Positioning Material Group; Preterm infants were placed in the nest with positioning material and placed in lateral and prone positions The positioning material and hand-face maneuver were applied together to the preterm infants in the Positioning Material Group 2, and they were given lateral and prone positions in this way; Other Names: Control Group
No Intervention: Standard Care; Standard care was used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newborn Position Assesment Tool	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.	Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
Newborn Stress Scale	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.	Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
Pulse rate assesment	Pulse rate/min	Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
Respiratory rate assesment	respiratory rate/min,	Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
Oxygen saturation assesment	Oxygen saturation %	Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position

Collaborators and Investigators

• Sponsor: Kirsehir Ahi Evran University
• Investigators: Study Director: Serap Balcı, Assoc. Prof., Istanbul University Cerrahpasa; Study Chair: Isil AR, PhD, Istanbul University Cerrahpasa

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: December 11, 2022
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: preterm; stress; position; physiological parameters
• Other Study ID Numbers: IAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No