The Effect of Maternally Scent-digested Blanket on Stress, Crying and Physiological Parameters of Premature Newborns
NCT06437106 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-05-31
Summary
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
- Family-centered Care
Interventions
- BEHAVIORAL
-
A blanket impregnated with the mother's odor
Intervention group 1 consists of premature babies who receive a blanket impregnated with the mother's odor.
- BEHAVIORAL
-
blanket without mother's smell
Intervention group two consists of preterm infants who receive blanket without mother's odor.
- BEHAVIORAL
-
control group
The control group includes premature babies who are not subjected to any intervention and receive the usual care.
Sponsors & Collaborators
-
Istanbul University - Cerrahpasa
lead OTHER
Principal Investigators
-
shahla shafaati laleh, Master · Turkey , Istanbul University- cerrahpasha
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 28 Weeks
- Max Age
- 36 Weeks
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-04-01
- Primary Completion
- 2024-07-01
- Completion
- 2024-12-30
Countries
- Turkey (Türkiye)
Study Locations
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