The Effect of Positioning With Material and Hand-Face Maneuver

NCT06136130 | Completed DMC

• 1 other identifier: IAR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Position

Keywords

preterm; position; stress; physiological parameters

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• Pulse rate assesment

  Pulse rate/min

  Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position

• Respiratory rate assesment

  respiratory rate/min,

  Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position

• Oxygen saturation assesment

  Oxygen saturation %

  Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position

Study Arms (2)

Positioning Material

EXPERIMENTAL

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

Device: Tortoise Positioning Material Group

Standard Care

NO INTERVENTION

Standard care was used

Interventions

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

Also known as: Control Group

Positioning Material

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm newborn between 28-32 weeks of gestation (very early preterm)
• Not connected to mechanical ventilator
• Parent's consent with informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsehir Ahi Evran University: lead

Study Sites (1)

Kocaeli University Hospital

Kocaeli, 34381, Turkey (Türkiye)

Location

Related Publications (1)

• Ar I, Balci S. The effect of the use of positioning materials and hand-face maneuvers on physiologic parameters and stress symptoms in preterm newborns. Ital J Pediatr. 2025 Jul 21;51(1):239. doi: 10.1186/s13052-025-02070-z.

  PMID: 40691617 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Serap Balcı, Assoc. Prof.

  İstanbul University Cerrahpaşa

  STUDY DIRECTOR

• Isil AR, PhD

  İstanbul University Cerrahpaşa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: UNKNOWN
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

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

Study Record Dates

• First Submitted: December 11, 2022
• First Posted: November 18, 2023
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: July 1, 2020
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)