Comparison of the effect of recorded lullaby of father and mother on pain and some physiological indicators in arterial blood sampling of neonates admitted to neonatal intensive care units
Comparison of the effect of recorded parental lullaby on pain and some physiological indicators in arterial blood sampling of neonates admitted to neonatal intensive care units of hospitals affiliated to Shiraz University of Medical Sciences
Design
Clinical trial with control group, 51 infants were randomly assigned to three groups: father lullaby, mother lullaby and control group based on random block, 17 people in each group.
Settings and conduct
For 51 eligible infants, randomization is performed using a block of 4, three modes A, B and control. If the infant is in group A, first during blood sampling in addition to the usual methods of pain relief for 10 minutes The father receives the recorded lullaby through headphones, and in group B the same thing will happen using the mother's recorded lullaby. In the third group, only routine pain relief care will be provided.
Participants/Inclusion and exclusion criteria
Gestational age between 38 and 42 weeks
Confirmation of the baby's hearing ability by the doctor
Apgar in the normal range
No sedative use by the baby during the previous 24 hours
No substance abuse and sedative use by the mother
No congenital anomalies
No intracranial hemorrhage
The baby should not be under mechanical ventilation and CPAP
Intervention groups
Receiving a recorded lullaby of parents (two groups) for 10 minutes during arterial blood sampling through headphones
Main outcome variables
Heart rate, Blood oxygen saturation and Pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180923041101N4
Registration date:2022-04-18, 1401/01/29
Registration timing:prospective
Last update:2022-04-18, 1401/01/29
Update count:0
Registration date
2022-04-18, 1401/01/29
Registrant information
Name
Majid Najafi Kalyani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4251
Email address
najafikalyani@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-05, 1401/02/15
Expected recruitment end date
2022-11-06, 1401/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of recorded lullaby of father and mother on pain and some physiological indicators in arterial blood sampling of neonates admitted to neonatal intensive care units
Public title
Comparison of parental lullabies on pain and neonatal physiological parameters
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 38 and 42 weeks
Confirmation of the baby's hearing ability by the doctor
Apgar in the normal range
No sedative use by the baby during the previous 24 hours
No substance abuse and sedative use by the mother
No congenital anomalies
No intracranial hemorrhage
The baby should not be under mechanical ventilation and CPAP
Exclusion criteria:
Reluctance of parents to cooperation
Instability of physiological status in the infant
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible infants are randomly assigned to three groups of 17: father lullaby, mother lullaby, and control group, based on the four ABAB-BABA-ABBA-BAAB-AABB-BBAA blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
The research assistant and the evaluator of the results do not know in which intervention group the infants are. In this way, for the third group (control) to prevent the noise of the environment, headphones will be set without sound playback.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Schools of Nursing and Midwifery, Management and Medical Information science- - Shiraz University of
Street address
Zand
City
Shiraz
Province
Fars
Postal code
7193613119
Approval date
2021-12-18, 1400/09/27
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1400.064
Health conditions studied
1
Description of health condition studied
Neonates admitted to neonatal intensive care units
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score
Timepoint
From ten minutes before to ten minutes after neonatal arterial blood sampling
Method of measurement
NIPS scale
2
Description
Heart rate
Timepoint
From ten minutes before to ten minutes after neonatal arterial blood sampling
Method of measurement
Baby heart rate monitoring
3
Description
Blood oxygen saturation
Timepoint
From ten minutes before to ten minutes after neonatal arterial blood sampling
Method of measurement
Pulseoximetry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Father lullaby. First, a lullaby that is sung to the fetus during pregnancy or is about to be sung to the baby will be recorded by the father and will be ready to play for 10 minutes during the blood draw. The recorded lullaby of the father with controlled decibels (35 to 45 decibels) will be played for ten minutes during arterial blood sampling through a headphone that is connected to a sound player and placed on the baby's ear.
Category
Behavior
2
Description
Intervention group2: Mother lullaby. First, a lullaby that is sung to the fetus during pregnancy or is about to be sung to her baby will be recorded by the mother and will be ready to play for 10 minutes during the blood draw. The recorded lullaby recorded by the mother in controlled decibels (35 to 45 decibels) will be played for ten minutes during arterial blood sampling through a headphone attached to an audio player and placed on the baby's ear.
Category
Behavior
3
Description
Control group: Control. For the control group, headphones will be set without sound to prevent ambient noise.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazee Hospital
Full name of responsible person
Dr. Ahmad Hossein Zadeh
Street address
Zand
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
Nemazee_inf@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Poost Foroosh
Street address
Zand St, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
Vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Roozegar
Position
Master student of critical care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zand
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4255
Email
fruzegar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Majid Najafi Kalyani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazee St
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4251
Fax
Email
Najafikalyani@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Majid Najafi Kalyani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazee St
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4251
Fax
Email
Najafikalyani@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Analyzed data can be shared after completion of the study as an article
When the data will become available and for how long
The access period will start 6 months after the results are published.
To whom data/document is available
All of the researchers in Medical Sciences Universities
Under which criteria data/document could be used
Analysis of data based on statistical software
From where data/document is obtainable
Dr. Majid Najafi Kalyani
What processes are involved for a request to access data/document
Sending request, permission from Ethic Committee, sending data