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The Effect of Breast Milk Odor and Swaddling on Physiological Parameters and Stress Levels in Premature Infants Receiving Ventilator Support

NCT07681934 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-07-02

No results posted yet for this study

Summary

It will be done to shorten the hospital stay of the newborn and increase the quality of care by proving the positive effect of the safe wrapping method and the smell of breast milk on the physiological parameters and stress level of the newborn in premature newborns receiving mechanical ventilator support.

1. Safe wrapping method positively affects physiological parameters in premature newborns receiving mechanical ventilation support.
2. Safe wrapping method reduces stress in premature newborns receiving mechanical ventilation support.
3. Safe wrapping method increases comfort in premature newborns receiving mechanical ventilation support.
4. The smell of breast milk positively affects physiological parameters in premature newborns receiving mechanical ventilation support.
5. The smell of breast milk reduces stress in premature newborns receiving mechanical ventilation support.
6. The smell of breast milk increases comfort in premature newborns receiving mechanical ventilation support.

This study aims to answer the hypotheses

Conditions

  • Prematurity, Mechanical Ventilation

Interventions

OTHER

Breast Milk Smell

During the application, pre-test data and physiological measurement values, stress scale, and comfort scale levels are recorded three times, at the 5th and 20th minutes.

OTHER

Arson

In order to prevent the possibility of the wrapping increasing the body temperature, the incubator temperature, which is kept at a standard level, will be reduced by 1oC during the intervention. Pre-test data and physiological measurement values, stress scale and comfort scale levels will be recorded three times during the application, at the 5th and 20th minutes.

OTHER

Control

No intervention other than routine care will be applied to the control group of the study.

Sponsors & Collaborators

  • KTO Karatay University

    lead OTHER

Principal Investigators

  • Hediye Karakoç · KTO Karatay Üniversitesi

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
34 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-28
Primary Completion
2025-08-30
Completion
2026-08-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07681934 on ClinicalTrials.gov