Comparison of the effect of breastfeeding mothers and sensorial saturation on the physiological parameters and behavioral pain responses in infants after Pentavalent vaccine injection in 4 and 6 months.
The aim of study is to evaluate and Comparison of the effect of breastfeeding mothers and sensorial saturation on the physiological parameters and behavioral pain responses in infants after Pentavalent vaccine injection in 4 and 6 months. 180 infants will be divided randomly into three groups of breast-feeding by the mother ( Group 1 ) , sensory saturation ( Group 2 ) and control group ( Group 3). Inclusion criteria: No history of hospitalization, Having chronological age 4 months, Awake and calm infants and legal guardian 's consent intervention. Exclusion criteria : Cancel the legal guardian of continued cooperation in the project, Awareness of an infant developing chronic diseases during the two months between two stage intervention and complications attributed to the pertussis vaccine Pentavalent four months after vaccination. Population of the study is all 4 -month-old infants referring to health centers Yasouj Dastgheib martyr. Total sample size is 180 infants who will be divided into three groups of 60 people. Intervention group 1: Two minutes of breastfeeding to infant. Intervention group 2: Stimulate the five senses infants for two minutes. Group 3 will be the control group. Data collected four months after the first minute
Vaccination and in the second phase of the project after two months, later on same infants with full respect for the conditions before the intervention , will be. Then Data will be collected again. Primary outcome are Physiological parameters, behavioral pain responses infants and crying time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051527916N1
Registration date:2016-06-17, 1395/03/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-17, 1395/03/28
Registrant information
Name
Narges Kazemi Karani
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 7251
Email address
narges.kazemi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Yasuj University of Medical Sciences
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2016-09-05, 1395/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of breastfeeding mothers and sensorial saturation on the physiological parameters and behavioral pain responses in infants after Pentavalent vaccine injection in 4 and 6 months.
Public title
Comparison of the effect of breastfeeding mothers and sensorial saturation on Pain in infants after vaccination.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: No history of hospitalization due to illness or surgery in infants; Having chronological age 4 months; Do not receive Analgesic for 48 hours before vaccination by the mother and infant; Having a dominant fed with breast milk; Lack of feed for 30 minutes before vaccination; Awake and calm infants; Dry diaper for infants; Lack of cold or diarrhea, immunization; Infant being healthy and lack chronic disorder; No history of respiratory diseases and respiratory allergies; No history of hypersensitivity to lavender; Legal guardian 's consent intervention.
Exclusion criteria : Cancel the legal guardian of continued cooperation in the project; Awareness of an infant developing chronic diseases during the two months between two stage intervention; The infant admitted to the hospital during the two months between two stage intervention; Complications attributed to the pertussis vaccine Pentavalent four months after vaccination; Infant respiratory symptoms and skin allergy.
Age
To 6 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
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
Ethics committee of Yasuj University of Medical Sciences
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Sciences, Shahid Motahary Blvd., Yasuj, Iran Yasuj
Interventions 1: Breast-feeding by the mother to the infant will be for two minutes .
Category
Other
2
Description
Interventions 2: Senses of taste , smell , touch, sight and hearing of infants respectively by 2 ml 50% dextrose , two drops of lavender, massage the face and back , Look out for face and gentle talk will stimulate the infant .
Category
Other
3
Description
Control group: In this group there will be no intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center Shahid Dastgheib
Full name of responsible person
Ebrahim Momeni
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Yasuj University of Medical Sciences
Full name of responsible person
Doctor Mehdi Akbartabar turi
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Sciences, Shahid Motahary Blvd.
City
Yusuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Yasuj 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
Yasuj University of Medical Sciences
Full name of responsible person
Ebrahim Momeni
Position
Master of Science in Community Health Nursing Training-coach
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj
Postal code
Phone
+98 74 3323 5141
Fax
Email
momeni.ebrahim@yums.ac.iremomeni126@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Ebrahim Momeni
Position
Master of Science in Community Health Nursing Training
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj
Postal code
Phone
+98 74 3323 5141
Fax
Email
momeni.ebrahim@yums.ac.iremomeni126@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Narges Kazemi Karani
Position
MS student of Community Health Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj
Postal code
Phone
00
Fax
Email
narges.kazemi@yums.ac.irkazeminarges93@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)