The Effect of Breast Milk Odor and Swaddling on Physiological Parameters and Stress Levels in Premature Infants Receiving Ventilator Support
1. juli 2026 opdateret af: Hediye Karakoç, KTO Karatay University
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
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.
- Safe wrapping method positively affects physiological parameters in premature newborns receiving mechanical ventilation support.
- Safe wrapping method reduces stress in premature newborns receiving mechanical ventilation support.
- Safe wrapping method increases comfort in premature newborns receiving mechanical ventilation support.
- The smell of breast milk positively affects physiological parameters in premature newborns receiving mechanical ventilation support.
- The smell of breast milk reduces stress in premature newborns receiving mechanical ventilation support.
- The smell of breast milk increases comfort in premature newborns receiving mechanical ventilation support.
This study aims to answer the hypotheses
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
72
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Karatay
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Konya, Karatay, Tyrkiet (Türkiye), 42040
- KTO Karatay University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Breast Milk Smell Group
The premature newborn's own mother's milk will be dripped 10 drops onto a sterile gauze in a container one millimeter away from the newborn's nose, and the breast milk in the container will be placed in the incubator where the new baby is to be milked.
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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.
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Eksperimentel: Arson Group
A 90 cm² square muslin blanket will be used for wrapping.
During the application, care will be taken to leave a certain space between the blanket and the newborn in order not to restrict the newborn's movements and to leave a suitable area where the newborn's feet can be comfortable when folding the bottom of the blanket.
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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.
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Eksperimentel: Control Group
The control group of the study will not receive any intervention other than routine care.
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No intervention other than routine care will be applied to the control group of the study.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Premature Baby Comfort Scale
Tidsramme: 9 Months
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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.
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9 Months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Newborn Stress Scale
Tidsramme: 9 Months
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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.
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9 Months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Hediye Karakoç, KTO Karatay Üniversitesi
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
28. juni 2024
Primær færdiggørelse (Faktiske)
30. august 2025
Studieafslutning (Anslået)
30. august 2026
Datoer for studieregistrering
Først indsendt
19. august 2025
Først indsendt, der opfyldte QC-kriterier
1. juli 2026
Først opslået (Faktiske)
2. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2026
Sidst verificeret
1. august 2025
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Obstetrisk arbejde, for tidligt
- Obstetriske arbejdskomplikationer
- Graviditetskomplikationer
- Luftvejssygdomme
- Respirationsforstyrrelser
- Tegn og symptomer, luftveje
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- For tidlig fødsel
- Dyspnø
Andre undersøgelses-id-numre
- KARATAYU-SBF-ES-01
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