The Effect of Maternally Scent-digested Blanket on the Stress Level, Crying Duration and Physiological Parameters of Premature Newborns
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Infant stress level:
研究概览
简要总结
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).
详细描述
When preterm babies are admitted to the NICU, preterm babies are deprived of mother's hugs, sounds, and smells. Maternal involvement has recently been recognized as an important aspect of the care of hospitalized preterm infants that has a positive impact on clinical outcomes. Standard care in babies can cause stress, and following may cause pain in the baby over time. Both pharmacological and non-pharmacological approaches are used together to alleviate pain and reduce stress in infants. One of the non-medicinal methods is maternal odor. Researches has indicated that maternal odors, including breast milk, body odor, and amniotic fluid, particularly the odor of breast milk, can decrease stress reactions in newborn infants, such as crying and motor activity . The present study will be conducted with the aim of determining the effect of a blanket impregnated with the mother's smell on the amount of stress, crying duration and physiological parameters of premature babies
Method:
Place of the Research :
The data of current study will be collected on premature babies hospitalized in the neonatal intensive care unit of Al-Zahra Teaching and Research Hospital and Taleghani Teaching and Research Hospital, which are mother and baby friendly hospitals in Tabriz city.
Sample research:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Hospitalized for a second time during the data collection process. Lack of literacy in parents
结局指标
主要结局
Infant stress level:
时间窗: 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.
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.
Respiratory rate/minute:
时间窗: 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.
A stopwatch will be use to determine the respiratory rate in a minute of babies. The evaluation is done by the researcher.
Body temperature:
时间窗: 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.
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 duration of the baby's crying:
时间窗: The duration of the baby's crying is measured for one hour during the evaluation process. This will be done for 3 consecutive days
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
Oxygen saturation measurement:
时间窗: 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.
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.
Heart rate/minute:
时间窗: 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.
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.
次要结局
未报告次要终点
研究者
Shahla Shafaati Laleh
Principal Investigator
Istanbul University - Cerrahpasa