The aim of this cross-over clinical trial comparing the effectiveness of oral sucrose and swaddling, on pain of nasogastric tube placement is premature neonates. This study of 57 cases of samples available in selected medical centers, will do. All babies have qualified researcher after obtaining written informed consent from the parents of three nasal tube placement procedures - gastric by routine methods, will wrap and oral sucrose And depending on which of the groups were randomly assigned to be defined by the above three methods will be different. In this study, the two cameras to record behavioral responses and physiological responses to pain caused by neonatal nasogastric tube placement will be used. The information gathered will be used Split check list The first part of the research, including demographic characteristics and infant PIPP tool is the second part, which will be used to assess neonatal pain. Pain check list were interpreted by two experienced nurses and to determine the agreement between the scores of Cohen's Kappa agreement will be used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209304617N2
Registration date:2012-10-10, 1391/07/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-10, 1391/07/19
Registrant information
Name
Mahnaz Jabraeili
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
jabraeilim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-10-01, 1391/07/10
Expected recruitment end date
2013-05-31, 1392/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of oral sucrose and swaddling, on pain of nasogastric tube placement is premature neonates
Public title
comparing the effectiveness of oral sucrose and swaddling, on pain in premature neonates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: orders placed nasogastric tube by a doctor to be written or the indicated substitutions, gestational age infants between 34 to 28 weeks, birth weight more than a kilogram, absence Congenital anomalies in the nasal area, the lack of neurological deficits including seizures, intraventricular hemorrhage greater than grade 2, and ventricular Leukomalacia, the lack of any indication for surgery, not IUGR, severe medical conditions requiring treatments such as sedatives, muscle relaxants, antiepileptic, or analgesic drugs, Completed parental consent form and not painful procedure an hour before the start of procedure.
Exclusion criteria: video quality is not suitable for interpretation, placement of a nasogastric tube if the first is not possible, if the baby does not get to be an effective method of pain.
Age
From 28 years old to 34 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
57
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of research, Tabriz University of Medical Sciences
Street address
Deputy of Research, Tabriz University of Medical Sciences ,Golgasht street , Tabriz
City
Tabriz
Postal code
977-5138947
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
5/4/10778
Health conditions studied
1
Description of health condition studied
Reducing pain
ICD-10 code
Z40-54
ICD-10 code description
Persons encountering health services for specific procedures and health care
Primary outcomes
1
Description
Premature Infant Pain Profile (PIPP) Score
Timepoint
Two minute befor, During, Five minute after
Method of measurement
Standard PIPP Score
Secondary outcomes
empty
Intervention groups
1
Description
The first group, swaddling two minutes prior the intervention and the nasogastric tube will be inserted for them and will be monitored from two minutes before intervention until five minutes after intervention.
Category
Prevention
2
Description
The secode grope receiving 0.5 cc oral sucrose two minutes before the intervention and the nasogastric tube will be inserted for them and will be monitored from two minutes before intervention until five minutes after intervention.
Category
Prevention
3
Description
The third group received the routine approach and will be monitored from two minutes before intervention until five minutes after intervention.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Educational Center Affiliated Medical Sciences of Tabriz;Iran
Full name of responsible person
Shamsi Salimi
Street address
City
Tabriz
2
Recruitment center
Name of recruitment center
29 Bahman Hospital
Full name of responsible person
Street address
Rahnamai Street;Tabriz;Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research, Tabriz University of Medical Sciences
Full name of responsible person
Dr Ostad Rahimi
Street address
Research Department, Central Building , Golgasht , Tabriz Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Shamsi Salimi
Position
Nursing Master of Science Student
Other areas of specialty/work
Street address
Shariety South St. Faculty of Nursing & Midwifery, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1477 0724
Fax
Email
786yasisalimi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Jabraeili
Position
Ms, Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shariati South Street , Tabriz , Iran Tabriz
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
jabraeilim@tbzmed.ac.ir; jebreilim@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shamsi Salimi
Position
Nursing Master of Science Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shariati South Street , Tabriz, Iran Tabriz
City
Tabriz
Postal code
Phone
+98 41 1477 0724
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)