Determination of the effect of vibration on pain intensity during heel blood sampling in neonates
Design
The study will be a clinical trial with a parallel control group without blinding. In this study, 94 infants will be selected by sequential method and randomly divided into control and intervention groups with 4 blocks sampling
Settings and conduct
The research setting will be the neonatal intensive care unit of Rasoul Akraml and intervention will be performed on the third day of hospitalization during screening tests
Participants/Inclusion and exclusion criteria
Neonates with a gestational age of 47-37 weeks, weighing between 2500 and 4000 g without heart, respiratory and neurological problems and without physical and chromosomal abnormalities were included in this study.
Intervention groups
1- Assessment of pain before intervention in experimental and control groups.
1- produce vibration by placing mechanical vibrator, approximately 30 seconds before the heel stick, the vibrator will be applied over the mid/lateral calf, just below the knee for 30-second in in intervention group.
3- Re- assessment pain during heel blood sampling and 2 minutes after that in experimental and control groups.
Main outcome variables
Reduce pain during blood sampling by lancet the baby's foot
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160119026104N10
Registration date:2020-01-27, 1398/11/07
Registration timing:registered_while_recruiting
Last update:2020-01-27, 1398/11/07
Update count:0
Registration date
2020-01-27, 1398/11/07
Registrant information
Name
Mahnaz Shoghi
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4687 1192
Email address
shoghi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vibration on pain Intensity of Heel-Blood Sampling in Neonates
Public title
Effect of vibration on pain Intensity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Birth weight between 2500 to 4000 g
No analgesics or sedatives or anticonvulsants during the 12 hours prior to blood sampling
No experience of painful procedure 24 hours before the intervention
Exclusion criteria:
Heart, respiratory and neurologic problems or any chromosomal and anatomical abnormalities
Age
From 256 days old to 294 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
47
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation blocks of two groups with four blocks
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Pain measurement before intervention, Pain measurement during heel blood sampling, Pain measurement 2 minutes after heel blood sampling
Method of measurement
Premature Infant Pain Profile (PIPP)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use a mini vibrator(Norco MiniVibrator North Coast Medical Inc,NC70209, Gilroy, California) operates at 92 Hz and an amplitude of 0.6 mm) . to produce Vibration by placing the vibrator for 5 seconds before taking blood sampling from the baby's heel, in place of over the mid/lateral calf, just below the knee in accordance with the sural dermatome)
Category
Other
2
Description
Control group: Assessment of pain before, during and 2 minutes after taking blood sampling from infant's heel.