The Effect of Positioning With Material and Hand-Face Maneuver

Not Applicable

Completed

• Conditions: Stress; Position
• Interventions: Device: Tortoise Positioning Material Group

• Registration Number: NCT06136130
• Lead Sponsor: Kirsehir Ahi Evran University

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

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-09-01
• Study Completion: 2020-07-01
• Study First Submitted: 2022-12-11
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-14
• Last Update Submitted: 2023-11-14
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positioning Material	Tortoise Positioning Material Group	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

Primary Outcome Measures

Name	Time	Method
Newborn Position Assesment Tool	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	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	Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position	respiratory rate/min,
Pulse rate assesment	Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position	Pulse rate/min
Oxygen saturation assesment	Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position	Oxygen saturation %

Trial Locations

Locations (1)

Kocaeli University Hospital; 🇹🇷 Kocaeli, Turkey