To determine the effect of earmuffs and eye shields on pain in preterm infants during intravenous blood sampling in the NICUs.
Design
This study is a Randomised clinical trial with a Factorial design
Settings and conduct
The researcher will present the research environment (Rasool Akram hospitals). The samples will be selected through the sequential method and then the intervention order will be assigned through random assignment. Each newborn will receive one of the interventions during blood sampling in a random order within four days. For newborns with earmuffs or eye shields, earmuffs or eye shields will be applied by the researcher 4 hours before blood sampling. At the time of blood sampling, three people will be present at the site, including a fixed nurse to perform all blood sampling, the researcher to record the oxygen saturation and pulse rate from the monitor, the fixed nurse as a researcher's assistance to complete the pain assessment tool. researcher assistant to fill out the pain scale too.
Participants/Inclusion and exclusion criteria
Babies born to mothers with a history of drug abuse, or treated with antidepressants, have an APGAR below 6 in the 5th minute after birth, have congenital anomalies requiring surgery, grade 2 or higher ventricular hemorrhage will not be included in the study.
Intervention groups
A (without earmuffs and eye shields), B (with earmuffs only), C (with eye shields only), D (with earmuffs and eye shields).
Main outcome variables
Pain response during intravenous blood sampling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160119026104N5
Registration date:2019-02-06, 1397/11/17
Registration timing:retrospective
Last update:2019-02-06, 1397/11/17
Update count:0
Registration date
2019-02-06, 1397/11/17
Registrant information
Name
Mahnaz Shoghi
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4687 1192
Email address
shoghi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-21, 1397/08/30
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
2017-11-08, 1396/08/17
Actual recruitment end date
2018-05-20, 1397/02/30
Trial completion date
empty
Scientific title
Effect of earmuffs and eye shields on pain in preterm infants during intravenous blood sampling in the neonatal intensive care unite
Public title
The effect of earmuffs and eye shields to pain response
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Birth weight 1000 grams or more
Apgar score above 6 at 5th minutes after birth.
Not having painful procedures 4 hours before the intervention.
Non-administration of sedative and muscle relaxants for the newborn.
Clinical stability of the newborn.
Exclusion criteria:
having respiratory assist device.
Having chest tube.
having Congenital anomalies and metabolic disorders.
having intraventricular hemorrhage of grade 2 or more
Age
From 203 days old to 259 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
More than 1 sample in each individual
Number of samples in each individual:
1
Premature infants (37-39 weeks) admitted to the Neonatal intensive care unit
Actual sample size reached:
25
Randomization (investigator's opinion)
Randomized
Randomization description
First, we will randomize the allocation of treatments to the letters of the square. then we will design an arrangement of 4 letters in a 4 × 4 square array in such a way that each letter occurs once in each row and once in each column. For the Cyclic method, we will write the letters in the top row in alphabetical order. In the second row, shift the letters one place to the right. will Continue like this for other rows.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of IRAN University of Medical Sciences
Street address
school of Nursing and Midwifery.,Shahid yasemi Street., North Kordestan highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Approval date
2017-08-08, 1396/05/17
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9313387001
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Premature infant
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain during intravenous blood sampling
Timepoint
Before Intravenous blood sampling; During Intravenous blood sampling; After Intravenous blood sampling.
Method of measurement
Premature Infant Pain Profile Scale
Secondary outcomes
empty
Intervention groups
1
Description
Neonate Blood samples will be taken in 4-days with this sequence: ( A: Without eye shields and earmuff, B: With earmuff only, C: With eye Shields only, D : With eye shields and earmuff).
Category
N/A
2
Description
Neonate Blood samples will be taken in 4-days with this sequence: (B: With earmuff only, D: With eye shields and earmuff, A: Without eye shields and earmuff, C: With eye Shields only)
Category
N/A
3
Description
Neonate Blood samples will be taken in 4-days with this sequence: (C: With eye Shields only, A: Without eye shields and earmuff, D: With eye shields and earmuff, B: With earmuff only).
Category
N/A
4
Description
Neonate Blood samples will be taken in 4-days with this sequence: (D: With eye shields and earmuff, C: With eye Shields only, B: With earmuff only, A : A: Without eye shields and earmuff )
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasul Akram hospital
Full name of responsible person
Mahnaz Shoghi
Street address
school of Nursing and Midwifery.,Shahid yasemi Street., North Kordestan highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Email
shoghi.m@iums.ac.ir
Web page address
https://mail.iums.ac.ir/webmail/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seid Kazam Malakuti
Street address
School of Nursing and Midwifery, Shahid Yasemi Street., North Kordestan Highway., Tehran., IRAN
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
shoghi.m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
school of Nursing and Midwifery.,Shahid yasemi Street., North Kordestan highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
shoghi.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
school of Nursing and Midwifery.,Shahid yasemi Street., North Kordestan highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
shoghi.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Shahid Yasemi Street., North Kordestan Highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4356 1000
Email
shoghi.m@iums.ac.ir
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
Not applicable
Title and more details about the data/document
After Data coding in order to keep the confidentiality of the participants in the research.
When the data will become available and for how long
The end of sampling till six months after article publishing.
To whom data/document is available
Ethical, Reviewer and Editorial committees, Researchers.
Under which criteria data/document could be used
Systematic review and meta-analysis or secondary analysis citation .
From where data/document is obtainable
Mahnaz Shoghi, Email: shoghi.m@iums.ac.ir
What processes are involved for a request to access data/document
After sending a request to academic email, we will send our data files up to one week.