Comparison of the combined effect of maternal touch and sound with 50% glucose on reducing pain due to blood sampling in preterm infants
Design
The infants in the combined group received Jackson's sound and touch from the mother for 5 minutes. The mother would touch Yakson at the baby's bedside, whisper the previously mentioned lullaby, and draw blood at the same time. The Yakson protocol has key aspects of traditional Yakson (warm hands, gentle touch without pressure, and gentle hand movements) that are suitable for premature infants. In Yakson touch, the non-dominant hand is placed on the baby's back and the dominant hand is placed on the baby's chest and abdomen. Infants in the oral glucose group received 2 ml and blood sampling was performed after 2 minutes. The infants in the control group received routine care.
Settings and conduct
Premature infants referred to Ali Ibn Abitaleb Hospital in Rafsanjan from November 2016 to June 1400 were purposefully selected and randomly assigned to three equal groups of combination, oral glucose and control.
Participants/Inclusion and exclusion criteria
All premature infants weighing less than 2500 g, gestational age at birth at least 29 weeks and at most 36 weeks, lack of congenital anomalies, no intracranial hemorrhage or neurological problems, inability to take painkillers 24 hours a day They had arterial blood sampling and entered the study.
Intervention groups
The combined intervention of Yakson touch and maternal voice was performed on one group of infants and oral glucose in the other group and the control group did not receive any intervention.
Comparison of the effect of combination of touch and mother's voice with glucose 50% on pain reduction of Blood sampling in preterm infants
Public title
"Investigation of the combined effect of maternal touch and voice on neonatal pain"; "Evaluation of the effect of 50% glucose on infant pain relief"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
weight less than 2500 g
gestational age at birth at least 29 weeks and at most 36 weeks
lack of congenital anomalies
Failure to receive painkillers or sedatives within the previous 24 hours
No need for arterial blood sampling
Inequality of blood sampling in two blood samples
no intracranial hemorrhage or neurological problems
Exclusion criteria:
Need a ventilator
Need sedatives
Failure to draw blood the first time
Age
From 203 days old to 273 days old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Infants with inclusion criteria were randomly divided into three groups (A, B and C) with six alternate blocks. Six blocks (ABC, ACB, BAC, BCA, CAB and CBA) and a number between 1 and 6 were assigned to each block. The sequence of blocks was determined by rolling the dice.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the researcher was in charge of the intervention and one person entered the study as an outcome assessor who was not aware of the type of intervention in each group and a blind study was performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Jomhori Blvd
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.RUMS.REC.1397.263
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Infant pain
Timepoint
Before and after the intervention
Method of measurement
Neonatal Infant Pain Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The infants in the combined group received sound and Yakson touch from the mother for 5 minutes. The mother touched Yakson while the baby was in bed and while touching the lullaby she had already mentioned, she whispered and blood sampling was performed simultaneously. The Yakson protocol has key aspects of traditional Yakson (warm hands, gentle touch without pressure, and gentle hand movements) that are suitable for premature infants. In Yakson touch, the non-dominant hand is placed on the baby's back and the dominant hand is placed on the baby's chest and abdomen
Category
Other
2
Description
Intervention group 2: Infants in the oral glucose group received 2 ml and blood sampling was performed after 2 minutes.
Category
Other
3
Description
Control group: The infants in the control group received routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abitaleb Hospital in Rafsanjan
Full name of responsible person
Parisa Shahmohammadipour
Street address
Nurse Ave., Jomhori Blvd., Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
771896755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
heidarzadehazam@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinejad
Street address
Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0039
Fax
+98 34 3425 6961
Email
rvazirinejad@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Parisa Shahmohammadipour
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nurse Ave., Jomhori Blvd., Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
heidarzadehazam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Azam Heidarzadeh
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nurse Ave., Jomhori Blvd., Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
heidarzadehazam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Azam Heidarzadeh
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nurse Ave., Jomhori Blvd., Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
heidarzadehazam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available