The effect of eye shields and earmuffs on the pain of Orogastric Tube in premature infants in Neonatal Intensive care Unit
Design
Two arm parallel group randomized trial, random allocation blocking sampling, Sample size is110 for each group is 55 neonate
Settings and conduct
This research perform on 110 preterm infants between 36-28 weeks of gestation who are admitted in the NICU of Arash hospital.
Participants/Inclusion and exclusion criteria
inclusion: birth weight less than 2500 grams, Lack of mechanical ventilaion
exclusion:Congenital anomalies, or Genetic disorders
Intervention groups
Intervention group: The researcher uses earmuffs 4 hours before and during OGT treatment and eye shields are used 2 hours before OGT in intervention group. Then, the pain is measured for 30 seconds with Premature Infants Pain Profile 15 seconds before , during and after intervention.
Control group:they receive routine care only.
Main outcome variables
The pain of Orogastric Tube in preterm infants will be examined by premature Infants pain Profile scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101113005163N7
Registration date:2018-10-02, 1397/07/10
Registration timing:registered_while_recruiting
Last update:2018-10-02, 1397/07/10
Update count:0
Registration date
2018-10-02, 1397/07/10
Registrant information
Name
Akram sadat Sadat hoseini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 2998
Email address
ashoseini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Eye shields and Earmuffs on the pain of Orogastric Tube (OGT) in premature infants in Neonatal Intensive Care Unit (NICU)
Public title
The Effect of Eye shields and Earmuffs on the pain of OGT in premature infants in NICU
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The intrauterine age of the baby at birth on the basis of ultrasound in the first trimester of pregnancy and LMP between 28 weeks and 0 days to 36 weeks and 6 days
Birth weight less than 2500 grams
Healthy and vision-conscious babies
Exclusion criteria:
Any change in the condition of the baby during study days that results in receiving respiratory protection (attached to the ventylator) or receiving sedation or anticonvulsant
Emergency delivery of oral and gastroduodenal tubes
Congenital anomalies, or Genetic disorders
Mechanical ventilation
Consumption of effective drugs on the physiologic and therapeutic setting, such as anticonvulsants, sedation and opiate, at least 24 hours past
Performing painful procedures before the intervention
Infants who have had at least 24 hours of phototherapy treatment
Infants born of mothers who do not have a history of drug use during pregnancy
Age
From 3 days old to 50 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Neonates are selected in an accessible manner, and random allocation will be done in two intervention and control groups based on the blocking method. Random blocking is a randomized method that ensures that at each point of the research, roughly equal numbers of participants are assigned to all groups. The first step in determining the newborns in the intervention and control group is the formation of four blocks of intervention group (A) and control group (B).
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 of Tehran University of Medical Sciences
Street address
Nosrat St., Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-06-11, 1397/03/21
Ethics committee reference number
IR.TUMS.FNM.REC.1397.009
Health conditions studied
1
Description of health condition studied
neonatal pain
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Pain
Timepoint
Baseline which lasting 15 seconds before Intervention / During Intervention/30 seconds after the end of Intervention
Method of measurement
Premature Infants Pain Profile (PIPP) Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The researcher uses earmuffs (4 hours before and during inserting orogastric tube) and Eyeshield (2 hours before OGT) in this group. In order to compare pain in the normal state of the infant for 15 seconds in resting condition before performing OGT, during and after the completion of the work, pain measurement with Premature Infants Pain Profile is performed for 30 seconds. A camera captures facial manifestations and facial movements, and simultaneously captures another camera from the baby's pulse oximeter . The films are reviewed by the researcher and carefully studied in terms of changes in physiological and behavioral criteria, and the data will be entered and scaled according to PIPP tool criteria
Category
Other
2
Description
Control group: Newborn in the control group receive routine care. The pain is measured using the Premature Infants Pain Profile scale.