Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650189
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Investigation of the Effect of MuSic on the Stress of Preterm NeONates Through InnovATive Applications SONATA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigation of the Effect of Music on the Stress of Preterm Neonates Through Innovative Applications
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SONATA
Brief Summary:
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
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
Detailed Description:
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 072 and a significance level of 005
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 etc 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 neonates prenatal exposure of music as a fetus
Data collection Biomarkers Salivary samples will be obtained from preterm neonates via salivette swabs The polyester filter of the device will be partitioned into equal sections under sterile conditions to account for the small oral size of the neonates One sample will be obtained before the music intervention and one sample 60 minutes after the music intervention considering diurnal flow patterns Saliva sampling is unlikely to cause stress or pain to the neonate In the control group only one sample per day will be obtained within the same time period with the intervention group Sample collection will be repeated in the same way everyday for 5 consecutive days Each sample will be obtained before any stressful intervention eg blood sampling weighing bathing etc Furthermore it is important to note that no other procedure that may reduce stress will take place simultaneously with music intervention ie kangaroo care gentle touching etc in order to interpret the effect of music more precisely Saliva samples will be centrifuged very soon after collection and stored at -80oC until the laboratory analyses are performed Measurements will be performed with cobas e411 automated analyzer or through ELISA
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 072 and a significance level of 005
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 etc 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 neonates prenatal exposure of music as a fetus
Data collection Biomarkers Salivary samples will be obtained from preterm neonates via salivette swabs The polyester filter of the device will be partitioned into equal sections under sterile conditions to account for the small oral size of the neonates One sample will be obtained before the music intervention and one sample 60 minutes after the music intervention considering diurnal flow patterns Saliva sampling is unlikely to cause stress or pain to the neonate In the control group only one sample per day will be obtained within the same time period with the intervention group Sample collection will be repeated in the same way everyday for 5 consecutive days Each sample will be obtained before any stressful intervention eg blood sampling weighing bathing etc Furthermore it is important to note that no other procedure that may reduce stress will take place simultaneously with music intervention ie kangaroo care gentle touching etc in order to interpret the effect of music more precisely Saliva samples will be centrifuged very soon after collection and stored at -80oC until the laboratory analyses are performed Measurements will be performed with cobas e411 automated analyzer or through ELISA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None