Investigation of standard positioning effects of standard positioning on Physiological responses and pain in operated infants in NICU of children’s Hospital : a crossover clinical trial
The effect of standard positioning on physiological responses and pain of neonates admitted to NICU ward
Design
The alarms monitor the physiological responses 30 minutes, 15 minutes immediately before and immediately after, 15 minutes and 30 minutes later by the CRIES instrument, and again the nurse performs routine care procedures and arranges the baby accordingly. Slowly, as soon as the baby leaves the baby, the researcher will position the IPAT to the baby and maintain the standard position using the rolled towel. 30 minutes, 15 minutes and immediately before and immediately after, 15 minutes and 30 minutes after, the physiological responses were monitored and pain scores were assessed by the CRIES instrument
Settings and conduct
The study units are neonates hospitalized in NICU ward of Tabriz Pediatric Educational Center.The sampling will be done on the infants in the available manner. The statistical population consisted of all neonates over 32 weeks old and admitted to NICU ward of pediatric hospital. The study samples will then be selected by lot. The available samples are simply studied until we reach the desired sample size. Available sampling involves non-random selection of samples based on their availability or easy accessibility.
Participants/Inclusion and exclusion criteria
Ministers over 32 weeks old with no motor restrictive surgery or intubation
Intervention groups
The researcher gives the baby the IPAT position and will maintain the standard position using the rolled towel. 30 minutes, 15 minutes and immediately before and immediately after, 15 minutes and 30 minutes after, the physiological responses were monitored and pain scores were measured by the CRIES instrument.
Main outcome variables
Standard positioning is effective on the physiological responses of neonates admitted to the NICU ward.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191020045168N1
Registration date:2019-12-25, 1398/10/04
Registration timing:registered_while_recruiting
Last update:2019-12-25, 1398/10/04
Update count:0
Registration date
2019-12-25, 1398/10/04
Registrant information
Name
Leila Ebrahimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 4422 7173
Email address
leila.ebrahimpoor1363@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of standard positioning effects of standard positioning on Physiological responses and pain in operated infants in NICU of children’s Hospital : a crossover clinical trial
Public title
Investigation of standard positioning effects of standard positioning on Physiological responses and pain in operated infants in NICU
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Neonates over 32 weeks of surgery and admitted to NICU Pediatric Hospital
Neonates extubated after surgery
Exclusion criteria:
Transfer from NICU department to other department before sampling
Infant death before completing information
Perform restrictive surgeries and neck surgeries
Surgical neonates who are intubated after surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
NO.7،West Isar،Alley Isar 7.
City
tabriz
Province
East Azarbaijan
Postal code
5451657411
Approval date
2019-12-09, 1398/09/18
Ethics committee reference number
IR.TBZMED.REC.1398.938
Health conditions studied
1
Description of health condition studied
Investigation of standard positioning effects of standard positioning on Physiological responses and pain in operated infants in NICU
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Physiological responses and pain
Timepoint
30 minutes, 15 minutes and immediately before and immediately after, 15 minutes and 30 minutes later, controls physiological responses and scores with pain using the CRIES tool. The distance between the first and second times is 24 hours in the evening shift. No procedure is performed on the baby within 30 minutes before and after scoring
Method of measurement
CRIES pain tool
Secondary outcomes
empty
Intervention groups
1
Description
A nurse performs care procedures (baby changing probes, gavages, temperature measurements, etc.) on the baby, arranges the baby according to routine, the researcher 30 minutes, 15 minutes and immediately before and immediately, 15 and 30 minutes. The next minute, the physiological response is monitored and the pain score is assessed by the CRIES tool, and the nurse again carries out routine care procedures and arranges the baby, as soon as the baby leaves the baby, standardizing the position to the baby. The standard position will be maintained using the rolled towel. 30 minutes, 15 minutes and immediately before and immediately after, 15 minutes and 30 minutes after, the physiological responses were monitored and pain scores were assessed by the CRIES instrument.The distance between the first and second times is 24 hours in the evening shift. No procedures are performed on the baby within 30 minutes before and after scoring. The time of last analgesia and type of medication will be recorded. This study will work with each infant for two days for fixed procedures, fixed hours, and constant shifts to be measured.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Medical Research & Training Hospital
Full name of responsible person
Leila Ebrahimpoor
Street address
Ahar.Isar St..Isar Alley 7.Place 7
City
Tabriz
Province
East Azarbaijan
Postal code
5451657411
Phone
+98 41 4422 7173
Email
leila.ebrahimpoor1363@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Rashidi
Street address
Tabriz Khelban Golghasht, Central Building, Research Deputy
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
info@medfac.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Leila Ebrahimpoor Anbarloo
Position
Nursing Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isar Street. Isar 7.NO.7
City
Ahar
Province
East Azarbaijan
Postal code
5451657411
Phone
009844227173
Email
leila.ebrahimpoor1363@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Valizadeh
Position
Ph.D Fculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
School of Nursing and Midwifery, South Shariati Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
0474434796770
Email
valizadehl@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Ebrahimpoor Anbarloo
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO.7.West Issar.Alley 7.
City
Ahar
Province
East Azarbaijan
Postal code
5451657411
Phone
009844227173
Email
leila.ebrahimpoor1363@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document