Comparison of the effect of Cooling Gel Pad Versus Non-Nutritive Sucking on Pain during Hepatitis B Vaccination in Term born Infants
Design
Clinical trial with control group
Neonets are selected by convenience sampling and divided into three groups. In the first group we laid 90 second Cooling Gel Pad on selected tissue region then injection performed in same cooled region. In the second group, sucking was done for 2 minutes before and during the injection of the vaccine. Control group did not receive any intervention during vaccine injection.
Settings and conduct
Pain duration was assessed during 2 minute after intramuscular injection regularly every 30 second by researcher under NIPS pain scale. Cry time was recorded during 2 minutes after needle penetration by stopwatch
Participants/Inclusion and exclusion criteria
Healthy babies, term, normal birth weight, APGAR 7 and more, at least 2 hours, and at most 24 hours since birth.
Intervention groups
Cooling Gel Pad, Non-Nutritive Sucking and without intervention groups
Main outcome variables
_Pain relief
_Reduction of the duration of crying
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141004019399N2
Registration date:2018-09-02, 1397/06/11
Registration timing:retrospective
Last update:2018-09-02, 1397/06/11
Update count:0
Registration date
2018-09-02, 1397/06/11
Registrant information
Name
Hadi Najafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4335 9253
Email address
najafih901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2014-06-20, 1393/03/30
Expected recruitment end date
2014-08-20, 1393/05/29
Actual recruitment start date
2014-07-12, 1393/04/21
Actual recruitment end date
2014-09-21, 1393/06/30
Trial completion date
empty
Scientific title
Comparison of the effect Cooling Gel Pad Versus Non-Nutritive Sucking on the pain caused by the injection of hepatitis vaccine in newborns
Public title
Comparison of topical cryotherapy and Non-Nutritive Sucking on the pain caused by vaccine injection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Parent's informed consent and cooperation
fetal gestational age 42-37 weeks
4000-2500 gm birth weight
At least the last two hours of birth
Within 24 hours of birth is past
Body temperature is between 37.2 to 36
At least 30 minutes have passed since the last feeding a baby
Babies do not have addicted mothers
Exclusion criteria:
No desire to cooperate and participate parents
Mothers who are taking anti-epileptic drugs and anti convulsants
The baby cried, severe restlessness
Poor sucking and non- effective infant
Age
From 1 day old to 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
113
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
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 Mashhad University of Medical Sciences
Street address
Deputy of Research and Technology University, Building Qureshi, Daneshgah ُSt, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Approval date
2014-03-15, 1392/12/24
Ethics committee reference number
IR.MUMS.REC.1392.903
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
M79.60
ICD-10 code description
Pain in limb, unspecified
Primary outcomes
1
Description
Intensity of pain
Timepoint
Every 30 seconds to 2 minutes after the needle is inserted
Method of measurement
neonatal infant pain scale(NIPS)
Secondary outcomes
1
Description
Duration of crying
Timepoint
Cry time was recorded during 2 minutes after needle penetration by stopwatch.
Method of measurement
by Stopwatch
Intervention groups
1
Description
Intervention group1:The first group we laid 90 second Cooling Gel Pad on selected tissue region then injection performed in same cooled region.
Category
Rehabilitation
2
Description
Intervention group2: The second group, sucking was done for 2 minutes before and during the injection of the vaccine.
Category
Rehabilitation
3
Description
Control group : The control group did not receive any intervention during vaccine injection.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Educational, Research and Treatment Center
Full name of responsible person
Soheila karbandi
Street address
Daneshgah St,Ibn-e Sina St, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3859 1511
Email
karbandis@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Deputy of Research and Technology University, Building Qureshi, Daneshgah st, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3882 3255
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hadi Najafi
Position
MSc in Neonatal Intensive Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Doctora Crossroadsوءشساء
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3859 1511
Fax
Email
najafih901@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
soheila karbandi
Position
MSc Nursing Education, Faculty member of School of Nursing and Midwifery, Mashhad
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Doctora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3859 1511
Fax
Email
karbandis@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hadi Najafi
Position
School of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doctora Crossroads, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3859 1511
Fax
Email
najafih901@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Babies are admitted to the mother's case and there is no comprehensive information.