The effect of Gentle Human Touch during endotracheal suctioning on procedural pain response in preterm infant admitted to neonatal intensive care units.
Determining the effect of Gentle Human Touch during suction on the pain of preterm infants admitted to the neonatal intensive care unit
Design
Clinical trial study with a crossover design, in which subjects randomly receive a sequence of either suctioning with intervention- suctioning without intervention or suctioning without intervention- suctioning with
intervention.The total number of neonates is 40.
Settings and conduct
This is an experimental clinical trial.The study will be conducted in a Neonatal Intensive Care Unit,located in a teaching Akbarabadi hospital,affiliated to Iran University of Medical Sciences.In the intervention group, the neonates suctioning with Gentle Human Touch. In the control group, suction is performed only routinely.
Participants/Inclusion and exclusion criteria
Infants 27-34 weeks gestation, and weighing
above 1200 grams with tracheal intubation, and require suction
Intervention groups
In the intervention group, the neonates suctioning with Gentle Human Touch. In the control group, suction is performed only routinely.
Main outcome variables
Neonatal pain in response to suction with Gentle Human Touch
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180508039587N1
Registration date:2018-07-03, 1397/04/12
Registration timing:registered_while_recruiting
Last update:2018-07-03, 1397/04/12
Update count:0
Registration date
2018-07-03, 1397/04/12
Registrant information
Name
Soroor Parvizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1000
Email address
parvizi.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Gentle Human Touch during endotracheal suctioning on procedural pain response in preterm infant admitted to neonatal intensive care units.
Public title
The effect of Gentle Human Touch during endotracheal suctioning on procedural pain response in preterm infant
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalization in the neonatal intensive care unit
The gestational age between 27-34 weeks
The birth weight is 1200 grams and higher
Having a tube in the trachea
The need for mechanical ventilation
Not getting sedation or anesthetic four hours before the intervention
Not having skin disease and any skin contact disorder
Not to be exposed to any painful activity at least one hour before the intervention
The absence of congenital anomalies
Exclusion criteria:
Changing the clinical condition of the baby, such as sudden death of the baby or need for cardiopulmonary resuscitation
A sudden need for sedation or anesthetic
intracranial hemorrhage higher than degree II,
Need to install a chest tube
Having seizures
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The baby's face is captured for pain scoring during the intervention, and without naming the baby by the codes given to the infants, they are scored by the unawar assessor. The analyst is also unaware of the work routine.
Placebo
Not used
Assignment
Crossover
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
Iran university,Yasemi Rashid Ave.,Valie Asr Ave.Tehran Town
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Approval date
2017-12-08, 1396/09/17
Ethics committee reference number
IR.IUMS.REC 1396.9411451007
Health conditions studied
1
Description of health condition studied
The effect of Gentle Human Touch during endotracheal suctioning on procedural pain response in preterm infant
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score in Premature Infant Pain Profile
Timepoint
Measurement of pain 30 seconds before suctioning without intervention and with intervention. Measuring pain in 30 seconds after suctioning with intervention and without intervention.Comparison of pain score at these times occurs.
Method of measurement
Premature Infant Pain Profile
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:To evaluate the effect of Gentle Human Touch during endotracheal suctioning on procedural pain response in preterm infant,A total of 40 neonates with entry criteria and written consent from their parents are included in the study, which is used as a cross-over design.The intervention is performed by the researcher in a Gentle Human Touch in the infants during suctioning. Will be filmed up to 30 seconds after the intervention, and the heart rate changes and arterial oxygen saturation will be recorded from the monitor.Premature Infant Pain Profile (PIPP) is used to measure neonatal pain and the pain score is recorded. The pain score is compared with the score of the recorded pain from non-interventional items.
Category
Other
2
Description
Control group: Each neonate is considered as its control. In this study, crossover design is used.Intervention and non intervention for each newborn are determined randomly.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abadi Hospital
Full name of responsible person
Dr.Kashaki Mandana
Street address
Molavi Street,Tehran
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Malakoti Seyed Kazem
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
PR@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
Parvizi Soroor
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Iran university,Yasemi Rashid Ave.,Valie Asr Ave.Tehran Town
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
parvizi.s@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parvizi Soroor
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Iran university,Yasemi Rashid Ave.,Valie Asr Ave.Tehran Town
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
parvizi.s@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parvizi Soroor
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Iran university,Yasemi Rashid Ave.,Valie Asr Ave.Tehran Town
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
parvizi.s@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 confidentiality of the participants in the research.
When the data will become available and for how long
The end of sampling till six month 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
Soroor Parvizi, parvizi.s@iums.ac.ir
What processes are involved for a request to access data/document
After sending request by academic email,we will send them data files up to one week.