Comparison the effect of breastfeeding and oral glucose (10%) on the severity of pain and physiologic characteristics due to venous sampling in infants who Hospitalized in neonatal intensive care unit
Comparison the effect of breastfeeding and oral glucose (10%) on the severity of pain and physiologic characteristics due to venous sampling in infants who Hospitalized in neonatal intensive care unit.
Design
Clinical trial with control group, with parallel groups, without blinding
Settings and conduct
The researcher will refer to Seyedoshohada hospital and then the sample according to inclusion criteria will be divided to three homogeneous groups. Intervention will perform once for members of each group . Physiological responses will be documented 10 min before intervention, during intervention and 10 min after intervention and neonatal pain will be assessed during intervention.
Participants/Inclusion and exclusion criteria
Infants with gestational age more than 30 weeks,
Infants without congenital anomalies
Intervention groups
Intervention group 1: they will be embraced the mother and during blood sampling will be eaten breast milk.
Intervention group 2: they will be embraced the mother and during blood sampling will be eaten oral 10% glucose.
Control group: they will be embraced the mother without any intervention during blood sampling.
Main outcome variables
Physiological responses, Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190105042245N1
Registration date:2019-02-24, 1397/12/05
Registration timing:registered_while_recruiting
Last update:2019-02-24, 1397/12/05
Update count:0
Registration date
2019-02-24, 1397/12/05
Registrant information
Name
Mojgan Saeidinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3247 2508
Email address
m.saednejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of breastfeeding and oral glucose (10%) on the severity of pain and physiologic characteristics due to venous sampling in infants who Hospitalized in neonatal intensive care unit
Public title
Comparison the effect of breastfeeding and oral glucose (10%) on the severity of pain and physiologic characteristics due to venous sampling in infants
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age more than 30 weeks
Lack of congenital anomalies
Lack of mechanical ventilation
Exclusion criteria:
Having nutritional problems
receive sedatives three hours before intervention
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
The sample will be selected from preterm infants according to inclusion criteria. Thus, blocks will be created based on personal information and inside of each block will be divided to three equal parts. Each part is assigned to intervention group 1, intervention group 2 and control group, respectively.
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 Kerman University of Medical Sciences
Street address
Campus of Kerman medical science university,Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2018-12-15, 1397/09/24
Ethics committee reference number
IR.KMU.REC.1397.343
Health conditions studied
1
Description of health condition studied
Physiological responses
ICD-10 code
ICD-10 code description
2
Description of health condition studied
pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Arterial oxygen saturation
Timepoint
Before, during and after intervention
Method of measurement
Pulseoximetery
2
Description
Pulse rate
Timepoint
Before, during and after intervention
Method of measurement
Pulseoximetery
3
Description
Pain
Timepoint
During intervention
Method of measurement
NIPS Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: this group will be embraced the mother and they will be eaten breast milk. Physiological responses will be documented 10 min before intervention, during intervention and 10 min after intervention. Neonatal pain will be checked according to questionnaire.
Category
Other
2
Description
Intervention group 2: this group will be embraced the mother and they will be eaten oral 10% glucose. Physiological responses will be documented 10 min before intervention, during intervention and 10 min after intervention. Neonatal pain will be checked according to questionnaire.
Category
Other
3
Description
Control group: this group will be embraced the mother and will not perform any intervention. Physiological responses will be documented 10 min before intervention, during intervention and 10 min after intervention. Neonatal pain will be checked according to questionnaire.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyedoshohada Hospital
Full name of responsible person
Mojgan Saeidinejad
Street address
Seyedoshohada hospitalٍ, Esteghlal st.,
City
Kerman
Province
Kerman
Postal code
7617755178
Phone
+98 34 3252 6280
Fax
+98 34 3252 6400
Email
beh.host.seyyedshohada@police.ir
Web page address
http://teb.police.ir/hospitals
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Dehnaviyeh
Street address
Kerman medical sciences university, Haft bagh highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5402
Fax
+98 34 3132 5856
Email
rdehnavi@gmail.com
Web page address
http://kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mojgan Saeidinejad
Position
Nursing MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 8., Esteghlal st.,
City
Kerman
Province
Kerman
Postal code
7617795988
Phone
+98 34 3247 2508
Email
m.saedinejad@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mojgan Saeidinejad
Position
Nursing MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 8., Esteghlal st.,
City
Kerman
Province
Kerman
Postal code
7617795988
Phone
+98 342472508
Email
m.saedinejad@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mojgan Saeidinejad
Position
Nursing MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 8., Esteghlal st.,
City
Kerman
Province
Kerman
Postal code
7617795988
Phone
+98 34 3247 2508
Email
m.saedinejad@kmu.ac.ir
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
Relied on secrecy
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available