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NCT Number: NCT06136130

The Effect of Positioning With Material and Hand-Face Maneuver

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.

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Key information

Conditions

Stress Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Position Pregnancy Complications Premature Birth Urogenital Diseases

Age range

28 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University Hospital

Kocaeli, 34381, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tortoise Positioning Material Group

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. Pulse rate assesment

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

    Pulse rate/min

  4. Respiratory rate assesment

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

    respiratory rate/min,

  5. Oxygen saturation assesment

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

    Oxygen saturation %

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran University

Unknown

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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