Clinical trial NCT06136130: The Effect of Positioning With Material and Hand-Face Maneuver
Official title: The Effect of Positioning With Material and Hand-Face Maneuver on Physiological Parameters and Stress Symptoms in Preterm Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Position
Keywords: preterm
position
stress
physiological parameters
Lead sponsor: Kirsehir
Sponsor class: UNKNOWN
First posted: 2023-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Effect of Positioning with Material and Hand-Face Maneuver on Physiological Parameters and Stress Symptoms in Preterm Newborns
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Newborn Position Assesment Tool
timeFrame: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
measure: Newborn Stress Scale
timeFrame: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
measure: Pulse rate assesment
timeFrame: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
measure: Respiratory rate assesment
timeFrame: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
measure: Oxygen saturation assesment
timeFrame: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University Hospital
Study officials:
affiliation: İstanbul University Cerrahpaşa
name: Serap Balcı, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: İstanbul University Cerrahpaşa
name: Isil AR, PhD
role: STUDY_CHAIR
References: