Protocol summary

Study aim
Comparison of the effect breast milk odor and another breast milk odor on responses behavioral of pain caused by hepatitis B vaccination in premature neonates admitted to the Neonatal.
Design
The is a single-blind, randomized clinical trial study, so that observer evaluating pain response was not aware of which intervention had been administrated.
Settings and conduct
Every 2- 4 day, premature newborn get the first dose of hepatitis B vaccination at Ayatollah Rohani Hospital of Babol. Vaccine injection in all three groups under the same conditions, with the same and the same type of device is done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having 28 to 34 weeks gestational age, Minimum age of 2 days, Not having asphyxia, Not having any congenital malformation especially in the nose area, Not being under mechanical ventilation or CPAP. Exclusion criteria: Having neuromuscular complications and congenital abnormalities.
Intervention groups
Group 1: Newborns of the first group, 3 minutes before the study will be familiarized with their mother’s milk odor by a sterile swap perfumed which its distance from the neonate’s nose is 3 cm. Group 2: Newborns of the second group, 3 minutes before the study will be familiarized with another mother’s milk odor by a sterile swap perfumed which its distance from the neonate’s nose is 3 cm. Group 3: Newborns of the third group, 3 minutes before the study will be familiarized with Distilled water odor by a sterile swap perfumed which its distance from the neonate’s nose is 3 cm.
Main outcome variables
Behavioral pain responses

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190220042771N1
Registration date: 2019-05-18, 1398/02/28
Registration timing: registered_while_recruiting

Last update: 2019-05-18, 1398/02/28
Update count: 0
Registration date
2019-05-18, 1398/02/28
Registrant information
Name
Adeleh Saebi Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0597
Email address
a.saebi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-26, 1397/12/07
Expected recruitment end date
2021-02-25, 1399/12/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect breast milk odor and another breast milk odor on responses behavioral of pain caused by hepatitis B vaccination in premature neonates admitted to the Neonatal
Public title
The effect breast milk odor response to pain caused by hepatitis B vaccination
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having 28 to 37 weeks gestational age Minimum age is 2 days Have not asphyxia Haven’t any congenital malformation Especially in the nose area Not be under mechanical ventilation or CPAP
Exclusion criteria:
Baby will be deleted from the study if the diagnosis neuromuscular complications and congenital abnormalities.
Age
From 2 days old to 4 days old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the neonates into three groups with a table of random numbers (A random number table is a collection of numbers that are generated without a specific pattern or order and completely randomized, then samples are randomly selected by Randomizer software).
Blinding (investigator's opinion)
Single blinded
Blinding description
The is a single-blind, randomized clinical trial study, so that observer evaluating pain response was not aware of which intervention had been administrated.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2019-01-23, 1397/11/03
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.253

Health conditions studied

1

Description of health condition studied
The Pain of vaccine
ICD-10 code
M79.6
ICD-10 code description
Pain in limb, hand, foot, fingers and toes

Primary outcomes

1

Description
Behavioral pain responses
Timepoint
3 minutes before vaccination until the end of the vaccination
Method of measurement
PIPP (Premature infant pain profile) standard tool

Secondary outcomes

empty

Intervention groups

1

Description
Newborn’s of the first group, 3 minutes before the study will be familiarized with their mother’s milk odor by a sterile swap perfumed which its distance from the newborn’s nose is 3 cm.
Category
N/A

2

Description
Newborn’s of the second group, 3 minutes before the study will be familiarized with another mother’s milk odor by a sterile swap perfumed which its distance from the newborn’s nose is 3 cm.
Category
N/A

3

Description
Newborn’s of the third group, 3 minutes before the study will be familiarized with Distilled water odor by a sterile swap perfumed which its distance from the newborn’s nose is 3 cm.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Dr. Parvin Aziznejad Roshan
Street address
Mazandaran, Babol, Ganj Afrooz Avenue, Babol University of Medical Sciences.
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
aziznezhadroshan@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Reza Ghadimi
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
info@mubabol.ac.ir
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
Adele Seibi Amiri
Position
Master's student of neonatal intensive care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mazandaran, Babol, Ganj Afrooz Avenue, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
aziznezhadroshan@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Parvin Aziznejad Roshan
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran, Babol, Ganj Afrooz Avenue, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
aziznezhadroshan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Parvin Aziznejad Roshan
Position
Member of the faculty of the University of Medical Sciences of Babol
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran, Babol, Ganj Afrooz Avenue, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
aziznezhadroshan@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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