Study of the effect of environmental and behavioral interventions on the pain of preterm neonates candidated for heel blood sampling in the neonatal intensive care unit
The aim of this research is to study the effect of environmental and behavioral interventions on the pain of heel blood sampling in preterm infants. Materials and methods: A single-group clinical trial will be conducted. Thirty two infants with gestational age (GA) of 32-37 weeks will be evaluated in this study in both intervention and control stage. In the intervention stage, the effect of interventions such as noise reduction by ear-plugs, light reduction by blindfolds, reduction of nursing manipulation and creation of intrauterine position will be evaluated for neonates in the time period of 30 minutes before taking blood samples until 30 minutes after it. Then, the required information about the pain of newborns will be collected by the questionnaire measure in 5 stages (before interventions, two minutes before the blood sampling, during sampling, five minutes and 30 minutes after the sampling). In the control stage, no behavioral and environmental intervention will be performed, while the required information will be collected similar to the intervention stage. Inclusion criteria include: GA: 32-37 weeks; age below 7 days; giving no oxygen before and during interventions; receiving at least 2 orders of heel stick blood sampling during two continuous days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092024100N1
Registration date:2016-11-27, 1395/09/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-27, 1395/09/07
Registrant information
Name
fatemeh baharlooei
Name of organization / entity
isfahan univercity of medical science
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2525
Email address
marofi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University Of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
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
Study of the effect of environmental and behavioral interventions on the pain of preterm neonates candidated for heel blood sampling in the neonatal intensive care unit
Public title
The effects of developmental care on the pain that preterm infants suffer during heel blood sampling in neonatal intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria include: gestational age between 32-37 weeks; age below 7 days; hospitalized in neonatal intensive care unit; giving no oxygen before and during interventions; full consciousness; receiving at least 2 orders of heel blood sampling in two continuous days; not receiving anticonvulsants and anesthetic drugs; lack of diseases such as congenital defects, neurological disorders, bleeding into the ventricles of the brain, and seizure. Exclusion criteria include: Cancellation of participation in research by newborn parents; the need for oxygen therapy in children for any reason before and during the intervention.
Age
From 1 day old to 7 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University Of Medical Science
Street address
Isfahan University Of Medical Science, Azadi square, Isfahan
City
Isfahan
Postal code
Approval date
2014-11-22, 1393/09/01
Ethics committee reference number
393862
Health conditions studied
1
Description of health condition studied
Preterm Neonate
ICD-10 code
xvi
ICD-10 code description
Certain conditions originating in the perinatal period
Primary outcomes
1
Description
The pain of heel blood sampling
Timepoint
Before intervention, two minutes before heel blood sampling, during heel blood sampling, five minutes after heel blood sampling and 30 minutes after heel blood sampling
Method of measurement
Infant Pain Scale (NIPS)
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention stage, the effect of interventions such as noise reduction by ear-plugs, light reduction by blindfold, reduction of nursing manipulation and creation of intrauterine position will be measured for neonates in the time period of 30 minutes before taking blood samples until 30 minutes after it. In the control stage, no behavioral and environmental intervention will be performed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Fatemeh Baharlooei
Street address
Shahid Beheshti Hospital, Felezi Bridge, Hakim Nezami Avenue,
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan university of medical science
Full name of responsible person
Dr.taleghani
Street address
Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan university of medical science
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
Isfahan Univercity Of Medical Sceince
Full name of responsible person
Fatemeh Baharlooei
Position
license/Nurse
Other areas of specialty/work
Street address
No. 11, Farid Alley, Motahhari Alley, Vahid Street,
City
Isfahan
Postal code
Phone
+98 31 3775 3779
Fax
Email
f.baharlooei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University Of Medical Sceince
Full name of responsible person
Maryam Marofi
Position
Master Of Science
Other areas of specialty/work
Street address
Isfahan University Of Medical Sceince, University of Isfahan, Azadi square, Isfahan
City
Isfahan
Postal code
Phone
+31 37922525
Fax
Email
marofi@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Fatemeh Baharlooei
Position
Other areas of specialty/work
Street address
No. 11, Farid Alley, Motahhari Alley, Vahid Street,
City
Isfahan
Postal code
Phone
+98 31 3775 3779
Fax
Email
f.baharlooei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)