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

N/AActive Not RecruitingNCT07681934

KTO Karatay University72 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Interventions

Breast Milk SmellOTHER

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.

ArsonOTHER

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.

ControlOTHER

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

Eligibility

Sex: ALLMin age: 34 WeeksMax age: 36 Weeks

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Premature Baby Comfort Scale

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.

Time frame: 9 Months

Secondary Outcomes

Newborn Stress Scale

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.