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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06437106 on ClinicalTrials.gov