Actively Recruiting
The Effect of Maternally Scent-digested Blanket on Stress, Crying and Physiological Parameters of Premature Newborns
Led by Istanbul University - Cerrahpasa · Updated on 2024-05-31
60
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Olfaction is a highly developed and crucial sensory modality that connects the infant and the mother, facilitating the infant's ability to locate and reach the mother's breast. the olfactory important sensory ability develops during intrauterine life . By the 11th week of pregnancy, human embryos have completely developed olfactory cells, indicating the complete formation and functionality of the olfactory sensory system during the first trimester . Hence, the olfactory sense undergoes development between the 26th and 28th weeks of pregnancy and, like other senses, plays a role in producing both motor and emotional responses .The mature olfactory system of newborn infants also effectively reduces pain and distress. The results of some studies have shown that the mother's voice and the smell of breast milk can reduce discomfort scores and analgesic effects during painful procedures . Odors can trigger the release of neurotransmitters, such as endorphins, in infants. Neurotransmitters are released in infants to alleviate painful stimuli, leading to a drop in stress levels . Researchers clinical experience shows that covering the baby calms and reduces crying. But no evidence-based studies have been conducted. The present study is planned in the form of a randomized controlled trial design and will investigate the effect of a blanket impregnated with the mother's scent on the amount of stress, duration of crying and physiological parameters of premature infants admitted to the NICU. Hypotheses: In premature newborns; H1: Covering with a blanket with maternal scent digested reduces the stress level of newborns. H2: Covering with a blanket with maternal scent digested reduces the crying time of newborns. H3: Covering with a blanket with maternal scent digested positively affects the physiological parameters of newborns. H4: Covering with a blanket with maternal scent digested is more effective in reducing the stress level of newborns than covering with a blanket without maternal scent and the control group (babies not covered). H5: Covering with a blanket with maternal scent digested is more effective in reducing the crying time of newborns than covering with a blanket without maternal scent and the control group (babies not covered). H6: Covering with a blanket with maternal scent digested affects the physiological parameters of newborns more positively than the cover with maternal scent undigested and the control group (babies not covered).
CONDITIONS
Official Title
The Effect of Maternally Scent-digested Blanket on Stress, Crying and Physiological Parameters of Premature Newborns
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Baby is in the neonatal period (0 to 28 days old)
- Admitted to the neonatal intensive care unit (NICU)
- Born between 28 and 36 weeks of pregnancy
- General condition of the baby is stable
- No conditions preventing pain assessment (such as intracranial bleeding, neuromotor delay)
- Baby has not been sedated in the last 6 hours
- Baby's breastfeeding completed at least 30 minutes before intervention
- Baby weighs more than 1000 grams
- Baby's Apgar score is high
- Family consents to participate in the study
You will not qualify if you...
- Baby is hospitalized a second time during data collection
- Parents are not literate
AI-Screening
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Trial Site Locations
Total: 1 location
1
Istanbul - cerrahpasha University
Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
S
shahla shafaati laleh, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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