Evaluation the effect of adjusting environmental stimuli on pain when inserting a central catheter in neonates admitted to the neonatal intensive care unit
Determining the effect of Decrease environmental stimuli, light and sound, on pain in premature infants when inserting a central venous catheter with peripheral access
Design
A clinical trial including the control and intervention groups with parallel, non-blind, non-randomized groups was conducted on 60 infants.
Settings and conduct
The researcher will be present in the NICU of Abuzar and Imam Hospitals in Ahvaz from 8:00 a.m. to 19:30 and will choose the infants who are the candidates for inserting the central venous catheter with peripheral access. They are divided into two groups of intervention and control and are investigated. The neonatal pain is measured and recorded in the intervention group by premature infant pain measuring instrument (PIPP) while a central venous catheter is inserted, and an eye shield and an earmuff were used for the infants' eyes and ears to reduce the light and sound. Also, the neonatal pain will be measured by PIPP in the control group without any intervention (reduction of peripheral stimuli) while a central venous catheter is inserted.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. The baby is 37-32 weeks old.
2. Have normal vital signs.
Exclusion criteria:
Congenital anomalies
Intervention groups
The intervention group: in this group, the neonatal pain was investigated in 30 premature infants while a central venous catheter was inserted and the light and sound were reduced by using an eye sheild and an earmuff of medicine New Matical brand. The pain was measured using premature infant pain measuring instrument. The control group: in this group, the neonatal pain was measured in 30 premature infants with no changes in light and sound while a central venous catheter was inserted.
Main outcome variables
neonate's pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200114046130N1
Registration date:2020-12-09, 1399/09/19
Registration timing:retrospective
Last update:2020-12-09, 1399/09/19
Update count:0
Registration date
2020-12-09, 1399/09/19
Registrant information
Name
Nargess Ranjbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3290 4432
Email address
nargess.ranjbari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
2019-08-23, 1398/06/01
Actual recruitment end date
2020-02-20, 1398/12/01
Trial completion date
2020-02-20, 1398/12/01
Scientific title
Evaluation the effect of adjusting environmental stimuli on pain when inserting a central catheter in neonates admitted to the neonatal intensive care unit
Public title
The effect of reducing environmental stimuli on infant pain when inserting a central venous catheter
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The baby is 37-32 weeks old.
He does not have a congenital disease.
Have normal vital signs.
Exclusion criteria:
Congenital anomalies
Age
To 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Not 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
Ethics Committee, Faculty of Pharmacy, Nursing and Midwifery, Shahid Beheshti University of Medical
Street address
Niayesh intersection, vali asr Blvd
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-06-19, 1398/03/29
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.062
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
pain
Timepoint
During catheterize of the central venous catheter
Method of measurement
premature infant pain profile
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: it includes thirty preterm infants admitted to the NICU of Abuzar and Imam Hospitals in Ahvaz city, they were as the candidates for embedding the central catheter with peripheral vascular access. The light and sound of the unit were reduced by using a medical earmuff of New Mathic brand and an eye sheild. The infant's pain was measured using premature infant pain measuring instrument while the central venous catheter was embedded.
Category
N/A
2
Description
Control group: The amount of pain in the newborn when inserting central venous catheter is measured without reducing the peripheral stimuli of light and sound .
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam KHomeini Ahvaz Hospital
Full name of responsible person
Nargess Ranjbari
Street address
Imam Khomeini Medical Center of Ahvaz, Azadegan street
City
Ahwaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Email
himam@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Abouzar Hospital Ahwaz
Full name of responsible person
Nargess Ranjbari
Street address
Abouzar hospital.Parastar avenue.
City
Ahwaz
Province
Khouzestan
Postal code
6163614175
Phone
+98 61 3444 3051
Email
Aboozar-hos@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
afshin zarghi
Street address
5th Floor, Bldg No.2, Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
14155-6153
Phone
+98 21 2243 9331
Email
zarghi@sbmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nargess Ranjbari
Position
Master's Student of Neonatal Intensive Care Unit
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nurssing and Midwifery University of Shahid Beheshti,Niayesh intersection, Vali asr Blvd,
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
Nargess.Ranjbari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nargess Ranjbari
Position
Master'Student of Neonatal Intensive Care Unit
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing Midwifery,Intersection of Niayesh.Vally Asr Street.
City
Tehran
Province
Khouzestan
Postal code
6352365640
Phone
88655366
Email
Nargess.Ranjbari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nargess Ranjbari
Position
MSc NICU Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Intersection of niyayesh ,Valiasr St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
Nargess.Ranjbari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Questionnaire information and only part of the main outcome
When the data will become available and for how long
6 months
To whom data/document is available
Nursing students and nurses
Under which criteria data/document could be used
Using in research related to knowledge of research subject
From where data/document is obtainable
Nargess Ranjbari. Nargess.Ranjbari@gmail.com
What processes are involved for a request to access data/document
The information will be available ten days after receiving the data email