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CompletedNCT06136130Updated Nov 18, 2023

The Effect of Positioning With Material and Hand-Face Maneuver

An interventional study of Tortoise Positioning Material Group in Stress and Position, sponsored by Kirsehir Ahi Evran University. Completed at 1 site in Turkey. Open to participants aged 28 Weeks to 32 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Kirsehir Ahi Evran University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 years 3 months after the study started (first participant enrolled Sep 2018, registered Dec 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
28 Weeks to 32 Weeks
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Stress
  • Position

Keywords

  • preterm
  • position
  • stress
  • physiological parameters
03

In context

Lead sponsor

This is the only study on the registry with Kirsehir Ahi Evran University as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Weeks to 32 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Positioning Material

    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

  • No intervention
    Standard Care

    Standard care was used

Interventions

  • DeviceTortoise 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

    Also known as: Control Group

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. Pulse rate assesment

    Pulse rate/min

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

  4. Respiratory rate assesment

    respiratory rate/min,

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

  5. Oxygen saturation assesment

    Oxygen saturation %

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

07

Study locations

1 site
  • Kocaeli University Hospital
    Kocaeli, 34381, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06136130
Lead sponsor
Kirsehir Ahi Evran University
Responsible party
Isıl AR (Research Assistant, Kirsehir Ahi Evran University) — Principal investigator
First posted
Nov 18, 2023
Start date
Sep 1, 2018
Primary completion
Sep 1, 2019
Completion
Jul 1, 2020
Last update
Nov 18, 2023

Study contacts

Serap Balcı, Assoc. Prof.
study director · İstanbul University Cerrahpaşa
Isil AR, PhD
study chair · İstanbul University Cerrahpaşa

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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