En the effect of breast milk oder on physiological and behavioral responses following venous blood
Design
Clinical trial with control group, with parallel groups,Two blind, randomized, with a sample size of 30
Settings and conduct
The impact of breastfeeding on physiological and behavioral responses following term infant venous blood sampling begins at the time of admission to Torbat-e-Heydariyeh Hospital. Nutrition training, pharmacy training, breastfeeding training, etc. are provided during the stay. Education is provided by a nurse with the help of a pamphlet, a medical booklet, and so on. The training is conducted after telephone discharge and lasts up to 12 weeks after discharge.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1-to-3 days 2-weight 2 to 5 g Non-Inclusion conditions: 1-Not willing to continue research.
Intervention groups
Intervention group: 531/5000In the mother's smell group, the infant will be used to stimulate the baby's olfactory odor, first in the morning before eating breakfast, then 2 cc of milk will be poured on the napkin and placed 2 cm from the baby's nose. This begins about 5 minutes before heel blood sampling and will continue until the procedure is completed. Physiological data (heart rate and arterial oxygen saturation percentage) will be recorded by pulse oximeter immediately before the intervention as baseline and immediately after the intervention when the heel blood sampling is completed.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191130045557N1
Registration date:2020-04-23, 1399/02/04
Registration timing:prospective
Last update:2020-04-23, 1399/02/04
Update count:0
Registration date
2020-04-23, 1399/02/04
Registrant information
Name
Hamideh Yaghoobi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5224 2463
Email address
hamideh.yaghoobi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of breast milk oder on physiological and behavioral responses following venous blood
Public title
the effect of breast milk oder on physiological and behavioral responses
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 3-5 daye
Weight 2500 to 3500 grams
Exclusion criteria:
Do not want to participate in research.
Age
From 3 days old to 5 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Simple randomization, using 174-bit Random Excel software with Excel, is generated sequentially with A and B bursts. The reader now has a patient range of 1 to 30, depending on whether he is in either of the A or B grades, in either of these two groups of patients.
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 Torbat Heydariyeh University of Medical Sciences
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St.
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
95196-33787
Approval date
2020-02-29, 1398/12/10
Ethics committee reference number
IR.THUMS.REC.1398.050
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
pain will be measured once before the first intervention and once after the last intervention session.
Method of measurement
Visual scale of pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 531/5000In the mother's smell group, the infant will be used to stimulate the baby's olfactory odor, first in the morning before eating breakfast, then 2 cc of milk will be poured on the napkin and placed 2 cm from the baby's nose. This begins about 5 minutes before heel blood sampling and will continue until the procedure is completed. Physiological data (heart rate and arterial oxygen saturation percentage) will be recorded by pulse oximeter immediately before the intervention as baseline and immediately after the intervention when the heel blood sampling is completed.
Category
N/A
2
Description
Control group: Except for the usual self-care training that all infants receive, no further action will be taken.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Nohome day Hospital, Torbat Heydarieh University of Medical Sciences
Full name of responsible person
Hamideh Yaghoobi
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St.
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95195481$6
Phone
+98 51 5222 6014
Email
hamideh.yaghoobi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Dr Hasann Azhdari Zarmehri
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St.
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95196-33787
Phone
+98 51 5222 8023
Email
azhdarizarmehri1@thums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Torbate-Heidaria 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
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Hamideh Yaghoobi
Position
Member of the faculty of Torbat Heydarieh University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St.
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95196-33787
Phone
+98 51 5222 6013
Email
hamideh.yaghoobi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Hamideh Yaghoobi
Position
Member of the faculty of Torbat Heydarieh University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
95169-33787
Phone
+98 51 5222 6013
Email
hamide.yaghoobi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Hamideh Yaghoobi
Position
Member of the faculty of Torbat Heydarieh University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St.
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9519633787
Phone
+98 51 5222 6013
Email
hamideh.yaghoobi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main consequence after being unidentified will be shared
When the data will become available and for how long
Start the access period 6 months after Publish results
To whom data/document is available
Everyone
Under which criteria data/document could be used
The results obtained in this study can be used without restriction by researchers.
From where data/document is obtainable
Referring to Torbat Heidarieh Nursing and Midwifery Faculty
What processes are involved for a request to access data/document
After sending the email to the person responsible for the response process begins.