Comparison of the effect of oral sucrose application and kangaroo Mother care on some physiological variables and pain of venous blood sampling in premature Newborns admitted to Neonatal Intensive Care Units
Objective: Comparison of the effect of oral sucrose application and maternal kangaroo care on some physiological variables and pain score of venous blood sampling in premature newborns admitted to neonatal intensive care units
Design
A single blind randomized controlled clinical trial with two experimental groups and one control group was assigned to 22 newborns in each group.
Settings and conduct
Couples of the week will be referred to Hafez Hospital and individual days to Hazrat Zeinab Hospital for sampling. Newborns in the kangaroo care group receive kangaroo care by their mothers 30 minutes before blood sampling.
In the oral sucrose group, 2 minutes before venous blood sampling 0.5ml the 24% oral sucrose solution is poured onto the anterior part of the newborns tongue using a syringe.
Physiological variables and pain scores were measured in all three groups five minutes before, during and 5 minutes after venous blood sampling. The pain assessment is done by a nurse colleague who is not aware of the assignment of samples to the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Premature infants with gestational age of 28-28 (infant age not exceeding 37 weeks after birth) with stable clinical status.
2. No use of pain medication or non-medication for pain control during the past 24 hours
3. Age after birth 48 hours or more, so that the corrected age is not more than 37 weeks.
Exclusion criteria:
1- Blood sampling from more than one place.
Intervention groups
The newborns in the experimental group consist of two groups. 22 newborns receiving maternal kangaroo care and 22 newborns receiving oral sucrose. newborns in the control group receive routine care and will receive no intervention.
Comparison of the effect of oral sucrose application and kangaroo Mother care on some physiological variables and pain of venous blood sampling in premature Newborns admitted to Neonatal Intensive Care Units
Public title
The effect of oral sucrose on Premature Newborns pain ";" The effect of kangaroo Mother care on Premature Newborns pain; "
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Premature Infants with Gestational Age of 28-37( Infant Age not exceeding 37 weeks after Birth) with stable clinical status.
Birth weight 1500 grams or more
Absence of cardiac, respiratory, infectious, neurological and metabolic defects
Apgar score of 7-10 at the first and fifth minutes
Feeding the baby from the mouth.
Failure to take painful measures one hour before starting study
No intrauterine growth retardation
Having a sucking reflex and response to painful stimulation.
No infant with diabetes
No necrotizing enterocolitis
No use of pharmacological and non-pharmacological measures of pain control during the past 24 hours
Age after birth 48 hours or more, so that the corrected age should not exceed 37 weeks.
Maternal non-addiction to cigarettes, alcohol, and drugs during pregnancy.
Moms with a good general outlook and a willingness to cooperate and not have a specific underlying illness in the mother
Exclusion criteria:
Blood sampling from more than one place.
Age
From 7 months old to 8 months old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The neonatal randomization was based on 3-digit permutation block method.
ABC
ACB
BCA
BAC
CBA
CAB
C: infants in control group A: infants in kangaroo care group B: Infants in oral sucrose group
Blinding (investigator's opinion)
Single blinded
Blinding description
In the two experimental groups, the pain score was assessed by a nurse colleague with experience of working in the neonatal ward and not knowing the allocation of samples to the relevant groups by using the Neonatal Infant Pain Scale (NIPS). He is well trained. The nurse will assess the pain score by examining the recorded videos.
Placebo
Not used
Assignment
Parallel
Other design features
In this study, intravenous blood sampling is performed between 8 am and 9 am by a skilled and experienced neonatal staff in each hospital who is considered as a research assistant and will be stable during the study.Couples of the week will be referred to Hafez Hospital and individual days to Hazrat Zeinab Hospital for sampling.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2020-01-15, 1398/10/25
Ethics committee reference number
IR.SUMS.REC.1398.1197
Health conditions studied
1
Description of health condition studied
Pain from intravenous blood sampling in premature newborns
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain Score
Timepoint
5 minutes before, during and 5 minutes after venous blood sampling
Method of measurement
Neonatal Infant Pain Scale
2
Description
Respiration Rate
Timepoint
5 minutes before, during and 5 minutes after venous blood sampling
Method of measurement
Oximeter Pulse
3
Description
Heart Rate
Timepoint
5 minutes before, during and 5 minutes after venous blood sampling
Method of measurement
Oximeter Pulse
4
Description
Percentage of Arterial Blood Oxygen
Timepoint
5 minutes before, during and 5 minutes after venous blood sampling
Method of measurement
Oximeter Pulse
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Newborns in kangaroo care group receive kangaroo Mother Care 30 minutes before intravenous blood sampling
Category
Other
2
Description
Intervention group: In neonates of oral sucrose group, 2 min before intravenous blood sampling 0.5 ml of 24% oral sucrose solution is poured onto the anterior part of the tongue using a syringe.
Category
Other
3
Description
Control group: In the control group, routine care will be taken and will not receive any intervention before venous blood sampling