The Effect of Positioning With Material and Hand-Face Maneuver

Sponsor
Kirsehir Ahi Evran University (Other)
Overall Status
Completed
CT.gov ID
NCT06136130
Collaborator
(none)
60
1
2
22
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Tortoise Positioning Material Group
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The Effect of Positioning with Material and Hand-Face Maneuver on Physiological Parameters and Stress Symptoms in Preterm NewbornsThe Effect of Positioning with Material and Hand-Face Maneuver on Physiological Parameters and Stress Symptoms in Preterm Newborns
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Positioning With Material and Hand-Face Maneuver on Physiological Parameters and Stress Symptoms in Preterm Newborns
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
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
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
Other Names:
  • Control Group
  • No Intervention: Standard Care

    Standard care was used

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. Pulse rate assesment [Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position]

      Pulse rate/min

    4. Respiratory rate assesment [Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position]

      respiratory rate/min,

    5. Oxygen saturation assesment [Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position]

      Oxygen saturation %

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    28 Weeks to 32 Weeks
    Sexes Eligible for Study:
    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:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kocaeli University Hospital Kocaeli Turkey 34381

    Sponsors and Collaborators

    • Kirsehir Ahi Evran University

    Investigators

    • Study Director: Serap Balcı, Assoc. Prof., İstanbul University Cerrahpaşa
    • Study Chair: Isil AR, PhD, İstanbul University Cerrahpaşa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Isıl AR, Research Assistant, Kirsehir Ahi Evran University
    ClinicalTrials.gov Identifier:
    NCT06136130
    Other Study ID Numbers:
    • IAR
    First Posted:
    Nov 18, 2023
    Last Update Posted:
    Nov 18, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Isıl AR, Research Assistant, Kirsehir Ahi Evran University

    Study Results

    No Results Posted as of Nov 18, 2023