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NCT Number: NCT07681934

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prematurity, Mechanical Ventilation Dyspnea Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases

Age range

34 week–36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KTO Karatay University

Konya, Karatay, 42040, Turkey (Türkiye)

About this study

The universe of the study will consist of premature newborns receiving ventilator support in the neonatal intensive care clinic of Selçuk University Medical Faculty Hospital. Three groups will be included in the study: the wrapping group (24), the breastfeeding group (24), and a control group (24). The study data will be collected using the Introductory Information Form, Preterm Infant Physiological Measurement Form, Premature Infant Comfort Scale, and the Neonatal Stress Scale. Before randomization, general information about the study will be given to the parents of newborns who meet the inclusion criteria, the mothers' consent will be obtained, and pre-test data will be collected. Premature newborns receiving ventilator support, whose pre-test data have been collected, will be assigned to the intervention and control groups using the simple randomization method. The intervention will be applied one hour after the 18:00 care, 10 minutes before the procedure, considering the calmest and most stable hours of the research unit, and will be evaluated at the fifth and twentieth minutes after the procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newborns with gestational weeks between 340/7-366/7,
  • In the first 28 days of life,
  • High-flow nasal cannula applied,
  • Birth weight 1500 gr and above,
  • Breastfeeding mothers,
  • No health problems that would prevent positioning,

Exclusion criteria

  • Those who have had a painful procedure within the last hour,
  • Those who have taken analgesic/sedative drugs within the last 6 hours,
  • Those who have undergone any surgical intervention,
  • Those with other diagnoses (hyperbilirubinemia, hypoglycemia, etc.),
  • Those with cerebral hypoxia/ischemia,
  • Those with intraventricular hemorrhage,
  • Newborns with congenital anomalies

Treatment and study plan

Breast Milk Smell

Other

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.

Arson

Other

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.

Control

Other

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

Primary outcomes

  1. Premature Baby Comfort Scale

    Time frame: 9 Months

    The scale was first developed by Ambuel et al. (1992) to assess the pain and stress levels of children aged 0-18 years hospitalized in a pediatric intensive care unit to determine the comfort levels of premature infants. It was later adapted by Caljouw et al. (2007) for premature infants aged 28-37 weeks. The scale is a 5-point Likert-type scale with seven subscales and 35 items. The subscales are defined as alertness, calmness/agitation, respiratory status or crying, physical movement, muscle tone, facial movements, and mean heart rate. The scale is a multidimensional measure that holistically assesses behavioral and physiological indicators of comfort in premature infants. As the total score on the scale increases, the infant's comfort level decreases; a score of 7 indicates the highest level of comfort, and a score of 35 indicates the lowest.

Secondary outcomes

  1. Newborn Stress Scale

    Time frame: 9 Months

    Developed by Ceylan and Bolışık (2017) to assess stress levels in premature infants, the scale consists of 24 items and 8 subscales: facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities, and posture. Each item is scored on a 3-point Likert-type scale from 0 to 2. The total score ranges from 0 to 16, with higher scores indicating higher stress levels.

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Registry information

Official study title

The Effect of the Safe Swaddling Method and the Scent of Breast Milk on Physiological Parameters, Stress, and Comfort Levels in Premature Newborns Receiving Mechanical Ventilator Support: A Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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