The Effect of Positioning With Material and Hand-Face Maneuver

NCT ID: NCT06136130

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-07-01

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

Conditions

Stress; Position

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Tortoise Positioning Material Group

Intervention Type: 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

Standard Care

Standard care was used

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Control Group

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

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kirsehir Ahi Evran University

UNKNOWN

Sponsor Role: lead

Responsible Party

Isıl AR

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serap Balcı, Assoc. Prof.

Role: STUDY_DIRECTOR

İstanbul University Cerrahpaşa

Isil AR, PhD

Role: STUDY_CHAIR

İstanbul University Cerrahpaşa

Locations

Kocaeli University Hospital

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 40691617 (View on PubMed)

Other Identifiers

IAR

Identifier Type: -

Identifier Source: org_study_id