Investigation of the Effect of Music on the Stress of Preterm Neonates Through Innovative Applications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Salivary stress biomarker 1 - Hormone
研究概览
简要总结
The goal of this prospective randomized clinical trial is to investigate the effect of music intervention on the stress of live born preterm neonates requiring admission to a Neonatal Intensive Care Unit, through the measurements of salivary biomarkers (hormones and proteins).
The main question it aims to answer is:
Can the daily music intervention reduce the stress levels created by the Neonatal Intensive Care Unit environment in preterm neonates?
Researchers will compare preterm neonates who will not be exposed to music intervention to investigate potential discrepancies in salivary stress biomarkers.
Participants will be exposed to recorded music for 5 consecutive days.
详细描述
Study Design In this prospective randomized controlled clinical trial, live born preterm neonates should have a stable clinical status at the time of study enrollment and therefore it is likely that some neonates will be enrolled after 5-7 days of admission. The allocation of neonates will be randomized in order to equalize the prognostic factors (confounding factors) between the groups. By using sequentially numbered envelopes, participants will be assigned to either intervention or control group by simple random allocation. In this way, researchers will avoid resulting in an unequal number of participants between the two groups. Researchers after obtaining parental informed consent, will request a sealed envelope from a staff member not involved in the study. The envelope will be opened and the allocation will be documented on a list, and signed by a member of the research team and a staff member as witness.
Participants The study will recruit preterm neonates. It has been estimated that with a sample of 35 neonates per group, the study will have more than 85% power to find differences in biomarkers between the intervention and control group, with an effect size equal to or greater than 0.72 and a significance level of 0.05.
Music Intervention Neonates will be placed in a closed incubator whose acoustic properties have been previously studied. Under the close surveillance of a team member, monitor alarms will be also silenced so as to decrease exposure to sudden and unpleasant auditory stimuli during music intervention. A mini portable speaker will be settled inside the incubator in appropriate conditions (volume level, distance e.t.c) for safety reasons.
Neonates allocated to the intervention group will be exposed to a specific piece of music, 30 minutes after feeding (if oral feeding exists), for a duration no more than 30 minutes that will be indicated from the certified music - therapist, experienced in working with preterm infants.
A questionnaire created by the research team will be administered to parents in order to investigate the neonate's prenatal exposure of music (as a fetus).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 28 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born between 28 - 36+6 weeks of gestation
- •Absence of active infection including blood, urine, cerebrospinal fluid
- •Absence of congenital and genetic disorders and chromosomal abnormalities
- •Absence of nuclear jaundice
- •Absence of endocrine disorders
- •Absence of maternal use of illicit drugs prenatally
- •Non - sedated neonates
- •Positive bilateral transient evoked otoacoustic emissions
- •Stable clinical condition
- •Absence of brain injury
排除标准
- •Diagnosis of brain injury after the enrollment
- •Negative auditory brainstem response before discharge
- •Clinical deterioration
结局指标
主要结局
Salivary stress biomarker 1 - Hormone
时间窗: From enrollment to 5 consecutive days.
Concentration of the hormone (Units: μg/dL).
Salivary stress biomarker 2 - Enzyme
时间窗: From enrollment to 5 consecutive days.
Concentration of the enzyme (Units: U/L).
Salivary stress biomarker 3 - Protein
时间窗: From enrollment to 5 consecutive days.
Concentration of the protein (Units: μg/mL).
次要结局
- Heart rate(Measured before, during, and after each music session daily. From enrollment to the end of intervention at 5 days.)
- Respiratory rate(Measured before, during, and after each music session daily. From enrollment to the end of intervention at 5 days.)
- Oxygen saturation(Measured before, during, and after each music session daily. From enrollment to the end of intervention at 5 days.)
- Blood pressure(Measured before, during, and after each music session daily. From enrollment to the end of intervention at 5 days.)
- Weight(Measured daily, with cumulative weight gain assessed at the end of the 5 days.)
- Head circumference(Day 1 and 5.)
- Daily volume of milk consumed.(Feeding efficiency will be analyzed over the 5-day period.)
- Length of hospitalization(From the date of hospital admission to the date of discharge, assessed up to 6 months.)
研究者
Dimitra Metallinou
Assistant Professor
University of West Attica