Protocol summary

Study aim
Comparing the effect of sucrose taste, maternal breast milk odor and taste on the pain associated with venous blood sampling in neonate
Design
In this study 90 newborns with jaundice diagnosis and inclusion criteria are selected. Participants randomly divided into three groups: breast milk odor, breast milk and sucrose tasting, and each participant will be assigned a code.
Settings and conduct
This study is carried out at Bu-Ali Sina hospital in Sari. At sampling, samples of all three groups are resting in the back under the Radiant heater in a quiet room with mild light and feeding with breast milk at least one hour before intervention. All infants undergo continuous monitoring of heart rate and arterial oxygen saturation before and during the study. In the sucrose taste group, 2 cc sucrose 24%, 3 minutes before the procedure is poured into the front of the infant's nose. In the maternal breast milk group, the 2-cc breast milk was infused by the syringe in the front of the baby's mouth 3 minutes before blood sampling. In order to bloom, in the sucrose flavor and the milk flavor group, the bullet is stained with normal saline, along with the nose. In the breast milk odor group, 2 cc of milk was poured on cotton balls for 3 minutes before to 30 seconds after blood sampling. 2 ml of normal saline is also infused into the baby's language 3 minutes before the procedure. The relevant questionnaires will be filled in by a person familiar with the pain assessment after interpreting the sampling film.
Participants/Inclusion and exclusion criteria
Neonates with gestational age 37 to 40 weeks, stable for vital signs, with jaundice diagnosis, no congenital anomalies, such as cleft palate and lumbar spine and choanal atresia, full vigilance, no other painful procedure before intervention, no feeding within a time interval Less than an hour before the intervention and the baby is not fasting. Non-refusal to continue to participate in research by parents, recipient of Pain killer drug, sedation and anticonvulsants, without abnormalities in the head and skull, and failure in venous sampling at first time
Intervention groups
Mother Milk Odor Group Mother Milk tasting group Sucrose tasting group
Main outcome variables
Pain variable

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170821035820N1
Registration date: 2017-12-12, 1396/09/21
Registration timing: registered_while_recruiting

Last update: 2017-12-12, 1396/09/21
Update count: 0
Registration date
2017-12-12, 1396/09/21
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 5581
Email address
a.modaresi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-16, 1396/06/25
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing The Effect Of Sucrose Taste, Maternal Breast Milk Odor And Taste On The Pain Associated WithVenous Blood Sampling In Neonate
Public title
Comparing The EffectOf SucroseTaste,MaternalBreast Milk Odor And Taste On The Pain Associated WithVenous Blood Sampling In Neonate
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Babies with gestational age 37 to 42 weeks Sustained in terms of vital signs With Diagnosis of icter Complete vigilance
Exclusion criteria:
Fasting Receive nutrition within less than an hour before the intervention Get another painful procedure before the intervention Congenital abnormalities such as cleft palate, lumbar spine and atresia quan Refuse to continue to participate in research by parents Abnormalities in the head and skull Failure in venous blood sampling at first time
Age
From 2 days old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Infants are randomly assigned to one of the three study groups with the help of a random number table and receive the intervention of the same group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Infants' parents and outcome evaluators are unaware of the patient's exposure. In each of the three groups, the cotton balls were stained with normal saline or milk for 3 minutes before 30 seconds after the sampling was placed next to the nose of the baby, and 2 cc normal saline or milk with 2 cc syringe also 3 minutes before the The procedure is poured on the language of the baby.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Babol University of Medical Sciences
Street address
Ganj Afroz Street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2017-06-25, 1396/04/04
Ethics committee reference number
mubabol.hri.rec.1396.9

Health conditions studied

1

Description of health condition studied
Comparing the effect of sucrose taste, maternal breast milk odor and taste on the pain associated with venous blood sampling in neonate
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
During intervention, After intervention
Method of measurement
Neonatal Infant Acute Pain Assessment Scale

Secondary outcomes

1

Description
Arterial oxygen saturation
Timepoint
Before intervention, during intervention, after intervention
Method of measurement
Mobile monitoring device

2

Description
Heart rate
Timepoint
Before intervention, during intervention, after intervention
Method of measurement
Mobile monitoring device

Intervention groups

1

Description
Intervention group: In the milk odor intervention group, 2 cc of milk was poured into cotton balls and placed for 3 minutes before to 30 seconds, and 2 cc of normal saline was poured into the baby's language 3 minutes before the procedure.
Category
Prevention

2

Description
Intervention group: In the group, the taste of sucrose, 2 cc sucrose 24%, is cast 3 minutes before the procedure in the front part of the baby's nose, and the cotton bullet stained with normal saline is placed next to the nose.
Category
Prevention

3

Description
Intervention group: In the breast milk taste group, 2-cc of maternal milk, by the syringe, is cast in the front of the baby's tongue 3 minutes before sampling, and the cotton ball covered with normal saline was placed next to the baby's nose.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Buali Sina Hospital
Full name of responsible person
Asiyeh Modaresi
Street address
Bu-Ali Sina Hospital, Imam Square, Pasdaran Blvd.
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3334 3012
Email
ac.modares@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Research Assistance
Street address
Ganj Afrouz Avenue, Babol University of Medical Sciences and Health services, Deputy Head of Research & Technology
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
ac.modares@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Asiyeh Modaresi
Position
Master's student nursing specialist neonates
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ganj Afrooz Street, Babol University of Medical Sciences and Health Services
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3310 5346
Fax
+98 11 3219 0181
Email
ac.modares@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Yadollah Zahed Pasha
Position
Neonatal Specialist, Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ganj Afrooz St., Babol University of Medical Sciences and Health Services
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 113219959296
Email
yzpasha@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Asiyeh Modaresi
Position
Master's student nursing specialist neonates
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ganj Afrooz Street., Babol University of Medical Sciences and Health Services
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3310 5346
Email
ac.modares@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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