The comparison of the effect of mother milk odor and non nutritive sucking on physiological and behavioral pain responses caused by hepatitis B vaccination in term infants.
After birth، infants are exposed to numerous painful measures and there is a talent for getting to the negative effects of pain. To reduce pain، Use of non-pharmacological methods of pain control are effective. in this study،The effect of two non-pharmacological pain managements (Non-nutritive sucking and olfactory stimulation with mother milk) is compared. The population of the study,infants born in the ninth day hospital in Torbat heydariye receive the first dose of hepatitis B vaccine, will form with gestational age of 37 to 42 weeks and birth weight of 2500 to 3500 gram and The last time they did not receive pain medication. infants will be selected by convenience sampling. A total of 90 samples were randomly divided into three groups, two groups, the smell of breast milk odor and non nutritive sucking and a control group exposed. in the breast milk odor group، Olfactory stimulation is done from three minutes before to completion of the vaccination. in the non nutritive sucking group، soft and standard Pacifier will be used of three minutes before to completion of the vaccination. In the control group nothing will be done before and after vaccination. Pain physiological responses (heart rate, respiratory rate and oxygen saturation) will be recorded in two stages, before and after the intervention and pain behavioral responses is recorded using standard tools for assessing pain in infants (MBPS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072423323N1
Registration date:2015-11-22, 1394/09/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-22, 1394/09/01
Registrant information
Name
Elaheh Amiri SHadmehri
Name of organization / entity
Gonabab University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5223 0259
Email address
amiri.e@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Gonabad University of Medical Sciences.
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of mother milk odor and non nutritive sucking on physiological and behavioral pain responses caused by hepatitis B vaccination in term infants.
Public title
The comparison of the effect of mother milk odor and non nutritive sucking on physiological and behavioral pain responses caused by hepatitis B vaccination in term infants.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: term infants with gestational age 37 to 42 weeks، apgar score 8 and higher than 8 in birth time، do not receive sedation drug from before 48 hours، The absence of congenital malformations. exclusion criteria: Any respiratory and digestive problems appearance during intervention، Discourage parents from participating in research.
Age
From 1 day old to 3 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
N/A
Randomization description
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
Gonabab University of Medical Sciences
Street address
KHorasan Razavi، Gonabad، Asian roadside، Gonabad University of Medical Sciences
City
Gonabad
Postal code
9691793718
Approval date
2015-06-24, 1394/04/03
Ethics committee reference number
ir.gmu.rec.1394.22
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
M79.6
ICD-10 code description
pain in limb
Primary outcomes
1
Description
heart rate، percent of oxygen saturation، breathing
Timepoint
Immediately before and after the intervention
Method of measurement
measuring heart rate In beats per minute، measuring oxygen saturation with use of pulse oximeter and respiratory rate in The number of movements of the chest in a minute
2
Description
pain behavioral responses
Timepoint
during vaccination
Method of measurement
infabt pain of assessment tool behavioral responses
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
in the mother milk odor group، 2ml from the infant 's mother milk، has been prepared in the morning before the start of nutrition،poured
on a gas is left at a distance of 3 cm from his nose. olfactory stimulation begins from 3 minuts before vaccination and continue to its completion.physiological responses are recored before and after the intervention and behavioral responses will be grade from the beginning to the end of the procedur.
Category
Prevention
2
Description
in the non nutritive sucking group، a kind of latex، soft and standard pacifier is used for each infant and with a soft pressure is kept in the mouth of the baby.This action sterted from 3 minute before vaccination and will continue until its completion. .physiological responses are recored before and after the intervention and behavioral responses will be grade from the beginning to the end of the procedur.
Category
Treatment - Drugs
3
Description
In the control group, no intervention is done. Physiological responses is recorded before vaccination and after its completion and Behavioral responses, will be graded from the beginning to the end of the procedure.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ninth day hospital city of Torbat Heydariye
Full name of responsible person
Elaheh Amiri SHadmehri، Graduate Student in Nursing Education، Nursing chidren
Street address
KHorasan Razavi، Torbat Heydariye ، GHarani bolvar، ninth day hospital
City
Torbat Heydariye
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Mohammadpour Ali, Research and Tecnology Departmant of Gonabad University of Medical Scienses, Pr
Street address
Gonabad، Asian roadside، Gonabad University of Medical Science
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
ninth day hospital
Full name of responsible person
Elaheh Amiri SHadmehri
Position
Graduate Student in Nursing Education, Nursing chidren
Other areas of specialty/work
Street address
KHorasan Razavi، Torbat Heydariye ، GHarani bolvar، ninth day hospital
City
Torbat Heydariye
Postal code
9518831166
Phone
+98 51 5222 6016
Fax
+98 52226022
Email
amiri602013@gmail.com
Web page address
www.thums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr moosa sajjadi
Position
nursing phd، Assistant Professor of Nursing، Gonabad University of Medical Sciences
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 51 5722 3028
Fax
Email
sajjadi1975@gmail.com
Web page address
www.gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
ninth day hospital
Full name of responsible person
Elaheh Amiri SHadmehri
Position
Graduate Student in Nursing Education, Nursing chidren
Other areas of specialty/work
Street address
KHorasan Razavi، Torbat Heydariye ، GHarani bolvar، ninth day hospital
City
Torbat Heydariye
Postal code
9518831166
Phone
+98 51 5222 6016
Fax
+98 52226022
Email
amiri602013@gmail.com
Web page address
www.thums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)