This study investigated the comparison of the effect of familiar olfactory stimulation (lavender scent) and glucose on pain from blood sampling in term neonates. This was a clinical trial study that carried out on 120 term neonate 3- 13 days that was allocated to three groups (each 40 neonates). In the first group, infants at night for 8 hours before blood sampling were exposed to the scent of lavender. And the next day, at the time of blood sampling was used of the scent of lavender. In the second group, infants 2 minutes before the taking blood sample received 2 cc edible glucose 30% and in the third group, without receipt specific intervention, blood samples were taken. Simultaneously with the needle, Douleur Aigue Nouveau-ne (DAN) scale by a trained person was calculated and recorded. Duration of crying in seconds from start cry to silence that lasted at least 5 seconds interval was measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010220529N1
Registration date:2015-02-16, 1393/11/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-16, 1393/11/27
Registrant information
Name
Naghmeh Razaghi
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
razaghin@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of familiar olfactory stimulation (lavender scent) and glucose on pain from blood sampling in term neonates
Public title
The effect of scent and glucose on pain of neonates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
a- Gestational age over 37 weeks,
b- Appearance, Pulse, Grimace, Activity, Respiration (APGAR) scores at five minutes greater than seven
c- Non-use of tranquilizer or sedative and anticonvulsant drug during the last 24 hours by mother and neonate
d- Need for venous blood sampling
e- Stability in general and clinical status
f- Oral feeding is not prohibited
g- The mother has not received any opioid
i- Lack of Diabetes in the mother.
Exclusion criteria:
a- If the baby in the familiar scent group, should be taken blood sampling during the orientation phase.
b- If the infants in the familiar scent group, during the familiar within scent up to blood sampling, was discharged or to cause any complications or problems that interfere with the natural trend of neonatal care, orientation phase stop.
c- If the infant receive milk or any sugar within thirty minutes prior to the start of the blood sampling.
d- If the infant is restless and uneasy before blood sampling.
e- If the first attempt for blood sampling was not successful.
Age
From 3 days old to 13 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Neonates (N = 120) were randomly assigned to three groups: aromatherapy (n = 40), glucose (n=40) and control group (n = 40). Method of sampling infants in this study is convenient sampling. Because it was probable for the other two groups to be exposed to the lavender scent spread from aromatherapy group (diffusion effect), sampling was done only for one group during each week, with groups being randomly selected; in other words, on the first day, the name of each group was written on a separate piece of paper, then was lottery. During each week, eligible cases were recognized and selected by convenience sampling only for one group, and groups were replaced respectively. Blinding was performed in a manner that the person who Implemented the pain scale was unaware of the purposes of research and study groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah Ave,Ghorashi building
City
Mashhad
Postal code
Approval date
2010-12-11, 1389/09/20
Ethics committee reference number
88474
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R52
ICD-10 code description
pain not referable to any one organ or body region
Primary outcomes
1
Description
Pain
Timepoint
Immediately after the entry of the needle into the vein
Method of measurement
Pain assessment scale scores Douleur Aigue Nouveau-ne (DAN).The scale is used to evaluate 3 items: facial expressions, limb movements and vocal expression
Secondary outcomes
1
Description
The duration of crying
Timepoint
According to seconds, in 3 minutes at the beginning of the blood sampling was measured.
Method of measurement
Stopwatch
Intervention groups
1
Description
Without receipt specific intervention for pain, blood samples were taken.
Category
N/A
2
Description
Infants at night for 8 hours before blood sampling were exposed to the scent of lavender. And the next day, at the time of blood sampling was used of the scent of lavender.
Category
Treatment - Other
3
Description
Infants 2 minutes before the taking blood sample received 2 cc edible glucose 30%
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hashemi Nezhad Hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences