The Effect of Positioning With Material and Hand-Face Maneuver

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Stress, Position

Intervention / Treatment
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* Device: Tortoise Positioning Material Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The Effect of Positioning with Material and Hand-Face Maneuver on Physiological Parameters and Stress Symptoms in Preterm Newborns
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positioning Material<br>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<br>* 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<br>* Other names: Control Group;|
| No Intervention: Standard Care<br>Standard care was used | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm, position, stress, physiological parameters