The Effect of Maternally Scent-digested Blanket on Stress, Crying and Physiological Parameters of Premature Newborns

NCT06437106 | Recruiting

• 1 other identifier: SSL&APM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

The smell of mother; baby; stress; physiological parameters

Outcome Measures

Primary Outcomes (6)

• Infant stress level:

  The stess levels of the infants will be evaluated via Infant stress scale. Infant stress scale was developed by Ceylan and Bolışık for assessing stress in premature infants contains 24 items: "facial expression", "body color", "breathing", "activity level", "relaxation", "muscle tone". ", "end limbs" and "body posture" consists of 8 subgroups: it is enough for the baby to show only one of the behaviors in each of the items for scoring. If the baby shows both signs (behavior) in Each of the items in the table (for example, both scores 1 and 2 will be the highest score for the action. This scale is designed on a 3-point Likert scale between 0 and 2 points). The maximum is 16 points and the minimum is 0 points. The higher the stress score, the higher the stress level of the baby is evaluated by the researcher.

  The stress level of the baby will be evaluated 5 minutes before the intervention, immediately after the intervention, every 15 minutes during the intervention and 5 minutes after the intervention for a total of one hour for 3 consecutive days.

• Oxygen saturation measurement:

  The oxygen saturation levels of the baby will be measured by a monitor that is connected to the baby and shows the level of oxygen saturation. The observation is done by the researcher.

  Oxygen saturation of the baby will be measured 5 minutes before the intervention, immediately after the intervention, every 15 minutes during the intervention and 5 minutes after the intervention, for a total of one hour for 3 consecutive days.

• Respiratory rate/minute:

  A stopwatch will be use to determine the respiratory rate in a minute of babies. The evaluation is done by the researcher.

  The infant's breathing is measured 5 minutes before the intervention, immediately after the intervention, every 15 minutes during the intervention and 5 minutes after the intervention, for a total of one hour for 3 consecutive days.

• Body temperature:

  Through a monitor that shows the baby's skin temperature. The temperature is recorded in Celsius in the newborn assessment form. The evaluation is done by the researcher.

  The baby's temperature is measured 5 minutes before the intervention, immediately after the intervention, every 15 minutes during the intervention and 5 minutes after the intervention, for a total of one hour for 3 consecutive days.

• Heart rate/minute:

  To determine the baby's heart rate, a monitor that is connected to the baby and measures the heart rate/minute will be used. The evaluation is done by the researcher.

  The baby's heart rate will be measured 5 minutes before the intervention, immediately after the intervention, every 15 minutes during the intervention and 5 minutes after the intervention, for a total of one hour for 3 consecutive days.

• The duration of the baby's crying:

  A stopwatch will be used to determine the duration of the baby's crying. The evaluation will be done by the researcher. The duration of the baby's crying in seconds will be recorded in the baby's evaluation form

  The duration of the baby's crying is measured for one hour during the evaluation process. This will be done for 3 consecutive days

Study Arms (3)

A blanket impregnated with the mother's odor

ACTIVE COMPARATOR

Intervention group 1 consists of premature babies who receive a blanket impregnated with the mother's odor.

Behavioral: A blanket impregnated with the mother's odor

blanket without mother's smell

ACTIVE COMPARATOR

Intervention group 2 includes premature babies who receive a blanket without the smell of the mother.

Behavioral: blanket without mother's smell

control group

ACTIVE COMPARATOR

The control group includes premature babies who receive no intervention and receive routine care.

Behavioral: control group

Interventions

A blanket impregnated with the mother's odor BEHAVIORAL

Intervention group 1 consists of premature babies who receive a blanket impregnated with the mother's odor.

A blanket impregnated with the mother's odor

blanket without mother's smell BEHAVIORAL

Intervention group two consists of preterm infants who receive blanket without mother's odor.

blanket without mother's smell

control group BEHAVIORAL

The control group includes premature babies who are not subjected to any intervention and receive the usual care.

control group

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The baby is in the neonatal period (babies between 0 and 28 days),
• Admission to the neonatal intensive care unit has been completed.
• Between 28 and 36 weeks of pregnancy,
• The general situation is stable.
• Not having conditions that prevent pain assessment (intracranial bleeding, neuromotor development delay, etc.),
• The child has not been sedated or sedated in the last 6 hours.
• Baby's breastfeeding should be finished 30 minutes before the intervention. Its weight is more than 1000 grams.
• Apgar score is high,
• Consent of the families to participate in the research

You may not qualify if:

• Hospitalized for a second time during the data collection process. Lack of literacy in parents

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul - cerrahpasha University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• shahla shafaati laleh, Master

  Turkey , Istanbul University- cerrahpasha

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shahla shafaati laleh, Master

CONTACT

00989364357181; shafaati.sh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention group one includes premature babies who receive a blanket impregnated with the mother's smell. The second intervention group includes premature babies who receive a blanket without the smell of the mother. The control group includes premature babies who do not receive any intervention and receive routine care.

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: May 31, 2024
• Study Start: April 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: December 30, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)