The Effect of Positioning With Material and Hand-Face Maneuver

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06136130
• Other study ID #: IAR
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: November 2023
• Source: Kirsehir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 1, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Position
• Stress

Intervention

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

Locations

Country	Name	City	State
Turkey	Kocaeli University Hospital	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kirsehir Ahi Evran University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Pulse rate assesment	Pulse rate/min	Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
Primary	Respiratory rate assesment	respiratory rate/min,	Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
Primary	Oxygen saturation assesment	Oxygen saturation %	Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position