The effect of facilitated tucking during endotracheal suctioning on pain and coping with stress in preterm infants: a randomized controlled crossover study
The aim is to examine the effect of facilitated tucking position during endotracheal suctioning on pain and coping with stress in preterm infants. This is a randomized controlled crossover trial. The population under study includes infants under mechanical ventilation. Sample size is 34 infants. The order of intervention/non-intervention will be randomly determined. Half of the infants receive suctioning without intervention, then suctioning with intervention; and the other half receive suctioning with intervention, then suctioning without intervention. To record data, video recording of the infants is done. Heart rate and oxygen saturation values are recorded from monitors.
Main inclusion criteria include age between 29 and 37 weeks gestational age, weight 1200 gram or more, and having endotracheal tube. Main exclusion criteria include having chest tube and receiving opioids or sedatives during past 4 hrs.
The intervention is as the following: the infant is placed on one side, the infant’s back is gently bended, the legs are got up and flexion at an angle greater than 90 degrees, the shoulders are also constricted up to 90 degrees and the researcher hands are placed over the head close to the mouth or on the infant’s face.
Main outcomes variables include pain and coping with stress that are measured immediately after suctioning by Preterm Infant Pain Profile and Neonatal Infant Pain Scale, respectively. Coping with stress is time duration required for achieving scores of one or zero based on Neonatal Infant Pain Scale which is measured every 10 seconds.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013062613785N1
Registration date:2013-08-02, 1392/05/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-02, 1392/05/11
Registrant information
Name
Hamid Peyrovi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4404
Email address
h-peyrovi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Institutional (Tehran University of Medical Sciences)
Expected recruitment start date
2013-02-08, 1391/11/20
Expected recruitment end date
2013-06-10, 1392/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of facilitated tucking during endotracheal suctioning on pain and coping with stress in preterm infants: a randomized controlled crossover study
Public title
The effect of facilitated tucking during endotracheal suctioning on pain and coping with stress in preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 29 and 37 weeks gestational age
Weight 1200 gr and more
Having endotracheal tube
Exclusion criteria:
Any congenital anomaly
Having chest tube
Any intracranial hemorrhage grade 2 or more
Receiving opioids or sedatives during past 4 hrs
Convulsion
Age
From 1 year old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
The study is single blind, because the infants do not have knowledge of treatment identification.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Ghods avenue, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2013-01-23, 1391/11/04
Ethics committee reference number
2731/130/د/91
Health conditions studied
1
Description of health condition studied
Respiratory failure
ICD-10 code
J96.9
ICD-10 code description
Respiratory failure, unspecified
Primary outcomes
1
Description
Suctioning associated pain
Timepoint
once, immediately after suctioning
Method of measurement
Preterm Infant Pain Profile (PIPP)
2
Description
Coping with stress
Timepoint
After suctioning, every 10 seconds, until the pain score reaches to 1 or 0 based on Neonatal Infant Pain Scale.
Method of measurement
Neonatal Infant Pain Scale (NIPS)
Secondary outcomes
empty
Intervention groups
1
Description
In cases where the infants is planned to undergo suctioning without intervention, the researcher assistant performs this and the researcher only records the study variables.
Category
Other
2
Description
In cases where the infant is planned to undergo suctioning with intervention, the researcher assistant carries out suctioning and the researcher implements the intervention. To implement facilitated tucking position , the infant is placed on his/her side, his/her back is gently bended, the legs are got up and flexed at an angle greater than 90 degrees, the shoulders are also constricted up to 90 degrees and the researcher hands are placed over the head close to the mouth or on the neonate’s face. The interval between suctioning without intervention and suctioning with intervention is at least two hours.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women Hospital
Full name of responsible person
Hamid Peyrovi
Street address
School of Nursing and Midwifery, Eastern Nosrat, Tohid Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran 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
School of Nursing and Midwifery
Full name of responsible person
Hamid Peyrovi
Position
Ph.D/ Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Eastern Nosrat, Tohid Square
City
Tehran
Postal code
1419733171
Phone
+98 21 6105 4404
Fax
+98 66904252
Email
h-peyrovi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Hamid Peyrovi
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Eastern Nosrat, Tohid Square
City
Tehran
Postal code
1419733171
Phone
+98 21 6105 4404
Fax
+98 66904252
Email
h-peyrvoi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Hamid Peyrovi
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Eastern Nosrat, Tohid Square
City
Tehran
Postal code
1419733171
Phone
+98 21 6105 4404
Fax
+98 66904252
Email
h-peyrovi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)