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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06136130
Enrollment
60
Registered
2023-11-18
Start date
2018-09-01
Completion date
2020-07-01
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Position, Stress

Keywords

preterm, position, stress, physiological parameters

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

Interventions

DEVICETortoise 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

Sponsors

Kirsehir Ahi Evran University
Lead SponsorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
28 Weeks to 32 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Newborn Position Assesment ToolBefore starting position, after 1 hour 1st position , before second positon, after 1 hour second positionThe 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 ScaleBefore starting position, after 1 hour 1st position , before second positon, after 1 hour second positionScale 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.
Pulse rate assesmentBefore starting position, after 1 hour 1st position , before second positon, after 1 hour second positionPulse rate/min
Respiratory rate assesmentBefore starting position, after 1 hour 1st position , before second positon, after 1 hour second positionrespiratory rate/min,
Oxygen saturation assesmentBefore starting position, after 1 hour 1st position , before second positon, after 1 hour second positionOxygen saturation %

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026