The goal of this research is investigating the local heat effects on the pain of heel blood sampling on term infants. The study's population is the infants who refer to shahid delkhah heal center of ferdows city to perform thyroid screening test. The infants with gestational age if 37 to 42 weeks,birth weight is 2500 to 4000 gr, have not been received sedation drugs the before night and awake, quite and without crying. Infants will be selected by convenient sampling. 63 infants are randomly divided into three groups: intervention, placebo and control. The stages study are: two minutes before, during and two minutes after blood sampling.heel infants in the intervention group heated by hair dryer ( temperature and distance same) for three minutes before lancing. in the placebo group used only sound of hair dryer for three minutes before lancing. in the control group did not perform any intervention. in the end The pain intensity is evaluated by researcher for each of the three groups by standard scale infants (NIPS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072223299N1
Registration date:2015-08-17, 1394/05/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-17, 1394/05/26
Registrant information
Name
Rahimeh GHobadi
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 5027
Email address
ghobadi.r@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Gonabad University of Medical Sciences
Expected recruitment start date
2015-08-06, 1394/05/15
Expected recruitment end date
2015-10-07, 1394/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect Local Heat on Pain of Heel Prick Blood Sampling in The Term Neonates
Public title
Effect of Local Heat on Pain Control Term Infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Infants with gestational age 37 to 42 weeks؛ first and fifth minutes apgar score higher than 7؛ birth weight 2500 to 4000 gr؛ The age of infant is between 3 to 5 days؛ body temperature between 36.5 to 37.5 C؛ born by vaginal delivery؛ healthy؛ infants has not been received sedation drug the before night؛ awake؛ quite and without crying. Exclusion criteria: infants who for them to be used double lancet to heel for blood sampling؛ parents dissuasion of stay infant in this 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:
63
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
Gonabad University of Medical Sciences
Street address
KHorasan Razavi. Gonabad. Gonabad University of Medical Sciences
City
Gonabad
Postal code
Approval date
2015-05-31, 1394/03/10
Ethics committee reference number
IR.GMU.REC.1394.18
Health conditions studied
1
Description of health condition studied
Heel pain during sampling
ICD-10 code
M79.6
ICD-10 code description
pain in limb
Primary outcomes
1
Description
Pain
Timepoint
Two Minutes Before, During, Two Minutes After Blood Sampling
Method of measurement
Neonatal Infant Pain Scale (NIPS)
Secondary outcomes
empty
Intervention groups
1
Description
infants heel in the intervention group were exposed local heat with hairdryer ( johnson model,1200 w, and distance 60 cm) for 3 minute before blood sampling.
Category
Prevention
2
Description
for Infants in the placebo group is used hairdryer voice alone, three minutes before blood sampling.
Category
Prevention
3
Description
infant in the control group has not taken intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
SHahid Delkhah Heal Center
Full name of responsible person
GHobadi Rahimeh, Graduate Student in Nursing Education, Nursing chidren
Street address
KHorasan Jonobi, Ferdows, Motahari Ave, SHahid Delkhah heal center
City
Ferdows
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabab 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 University of Medical Sciences
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabab 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
SHahid Delkhah Heal Center
Full name of responsible person
GHobadi Rahimeh
Position
Graduate Student in Nursing Education, Nursing chidren
Other areas of specialty/work
Street address
KHorasan Jonobi, Ferdows, Motahari Ave, SHahid Delkhah Heal Center
City
Ferdows
Postal code
Phone
+98 56 3272 6266
Fax
Email
ghobadi.m65@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Baloochi Tahereh
Position
Graduate in Nursing Education, Professor
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
tbaloochi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
SHahid Delkhah Heal Center
Full name of responsible person
GHobadi Rahimeh
Position
Graduate Student in Nursing Education, Nursing children
Other areas of specialty/work
Street address
KHorasan Jonobi, Ferdows, SHahid Delkhah Heal Center
City
Ferdows
Postal code
Phone
+98 56 3272 6266
Fax
Email
ghobadi.m65@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)