Assessing the effect of fetal position on severity of pain during chest tube removal in neonates undergoing open heart surgery
Design
To calculate the sample size, the Altman Nomugram was used. Considering , the sample size was calculated for eapch group of 30 people.
Settings and conduct
After obtaining the code of ethics from the Joint Ethics Committee from the Faculty of Nursing and Rehabilitation and the coordination of the officials of the Center for the Medical of Children's Hospital, a researcher in the Department of open heart Surgery of Neonatal Hospitals
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Complete the informed consent form for the neonates in the parent's research
Infants 1 to 28 days
Weight 2500 to 4000 grams
Separated from mechanical ventilation
Have a chest tube
Exit criteria:
- Infants with a prohibition (such as infants with chest infection and forbidden positions)
- Infants who have syndrome of deprivation of the substance (babies who receive opioed for more than 7 to 10 days often find physiological tolerance and require increased levels of sleep apnea and analesics to achieve optimal effects)’
Intervention groups
Receiving morphine by intervention and control group
Provide an embryo position to the intervention group's infants
The recording of hemodynamic symptoms in both groups by neonatal infant pain scale (NIPS)
Main outcome variables
Morphine
Fetal position
General information
Reason for update
Acronym
FPT
IRCT registration information
IRCT registration number:IRCT20181028041482N1
Registration date:2018-12-13, 1397/09/22
Registration timing:registered_while_recruiting
Last update:2018-12-13, 1397/09/22
Update count:0
Registration date
2018-12-13, 1397/09/22
Registrant information
Name
Somayeh Ashtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5537 7749
Email address
s_ashtari24@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-05-31, 1398/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of fetal position on the severity of pain during chest tube removal in neonates undergoing open-heart surgery
Public title
Assessing Fetal position in neonates undergoing open-heart surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Neonates with 1 to 28 days old
neonates with 2500 to 4000 grams weight
neonates extubed of ventilator
neonates with chest-tube
completion of consent form by parents
Exclusion criteria:
Neonates who have a prohibition of positioning (such as neonates with chest infection)
Neonates with drug deprivation syndrome
Age
From 1 day old to 28 days old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
30
30 neonates in the intervention group and 30 neonates will be in the control group.
Randomization (investigator's opinion)
Randomized
Randomization description
method of randomization: Simple randomization
unit of randomization: Individual
tools used in randomization: flip the coin
random sequence: single
Allocation concealment: single-blind
Blinding (investigator's opinion)
Single blinded
Blinding description
The parents of neonates were in the course of receiving their newborns' treatment, but they were not informed with either interventional or control groups, and thus single-blind study. In addition, neonatal nurses were not aware of the presence of newborns in the control or intervention group. The doctor in charge of removing the chest tube did not know the type of infant group.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qodse Ave, keshavarze Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-10-27, 1397/08/05
Ethics committee reference number
(IR.TUMS.FNM.REC.1397.136 (5/8/97
Health conditions studied
1
Description of health condition studied
Assessing the effect of fetal position on severity of pain during chest tube removal in neonates undergoing open heart surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of pain
Timepoint
Before intervention، During the intervention ، 5 minutes after intervention
Method of measurement
NIPS(Neonatal infant pain scale)
Secondary outcomes
1
Description
Severity of pain score
Timepoint
Before intervention, During the intervention ,5 minutes after intervention
Method of measurement
Neonatal infant pain Scale
2
Description
Fetal of position
Timepoint
Before intervention - during intervention - 5 minutes after intervention
Method of measurement
NIPS(Neonatal infant pain scale)
Intervention groups
1
Description
Intervention group: Neonates in the intervention group, in addition to the administration of 0.05 mg of morphine 20 minutes prior to the removal of the chest tube, the neonate is placed by the nurse trained in the fetal position and the chest tube is given by the physician who is for all Neonates of the two fixed groups are removed and the physiological signs of pain (heart rate-respiration and blood oxygen saturation) and neonatal pain infant scale (NIPS) before and immediately after removal of The chest tube is examined and recorded 5 minutes after removing the chest tube.
Category
Treatment - Drugs
2
Description
Control group:Neonates in the intervention group, in addition to the administration of 0.05 mg of morphine 20 minutes prior to the removal of the chest tube,and the chest tube is given by the physician who is for all Neonates of the two fixed groups are removed and the physiological signs of pain (heart rate-respiration and blood oxygen saturation) and neonatal pain infant scale (NIPS) before and immediately after removal of The chest tube is examined and recorded 5 minutes after removing the chest tube.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Somayeh Ashtari
Street address
Children's Medical Center, Qarib Street
City
Tehran
Province
Tehran
Postal code
1194815814
Phone
+98 21 5537 7749
Email
s_ashtari24@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Doctor Taqi zade
Street address
Faulty of Nursing Midwifery, West Nosrat St, Tohid square
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6105 4431
Email
tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Somayeh ashtari
Position
Master's student of neonatal intensive care nursing