Study of the effect of Newborn Individualized Developmental Care and Assessment Program (NIDCAP) on pain caused by eye examination of screening for retinopathy of prematurity.
Determination of the effect of Newborn Individualized Developmental Care and Assessment Program (NIDCAP) on pain caused by eye examination of screening for retinopathy of prematurity.
Design
A randomized, single blinded, controlled clinical trial with a parallel group design of 60 newborn infant with gestational age less that 34 weeks or birth weight less than 2000 grams
Settings and conduct
Infants in the intervention group at Umm al-Benin Hospital in Mashhad and the control group at Khatam Hospital in Mashhad were studied. The examination of the intervention group (including the insertion of ophthalmology speculum and taking pictures by RetCam) is performed by a nurse. The pain of the examination is measured by the PIPP tool. Filming and evaluation of the following criteria for behavioral status and facial expression of PIPP pain tool was done by one person (supervisor) after viewing the films.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Newborn infant with gestational age less that 34 weeks or birth weight less than 2000 g which four weeks have passed since their birth.
2-Infant's mothers are present
3-Their parents are satisfied to participate in this research
4-At least one hour has passed from infant's feeding
5-Infants must be calm and alert
6-Infants take no sedatives in past 24 hours
Exclusion criteria:
1-Infants which need ventilator during examination
2-Infants which had asphyxia during examination
Intervention groups
Intervention group: Infants undergo NIDCAP actions from one hour before the examination until one hour after the examination.
Control group: Infants of the control group are under common actions which are pouring anesthetic drops into their eyes and then eye examination by RetCam to determine their pain score based on PIPP tool.
Main outcome variables
The heart rate and oxygen saturation of infants are measured in both groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180114038361N1
Registration date:2018-06-18, 1397/03/28
Registration timing:prospective
Last update:2018-06-18, 1397/03/28
Update count:0
Registration date
2018-06-18, 1397/03/28
Registrant information
Name
Naimeh Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3823 4658
Email address
abbasin941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
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
Study of the effect of Newborn Individualized Developmental Care and Assessment Program (NIDCAP) on pain caused by eye examination of screening for retinopathy of prematurity.
Public title
The effect NIDCAP on pain caused by eye examination of screening for ROP
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Newborn infant with gestational age less that 34 weeks or birth weight less than 2000 g which four weeks have passed since their birth.
Infant's mothers are present
Their parents are satisfied to participate in this research
At least one hour has passed from infant's feeding
Infants must be calm and alert
Infants must have no surgical history
Infants must have no major congenital disorders like congenital heart or central nervous system disorders
Infants take no sedatives in past 24 hours
Exclusion criteria:
Infants which need ventilator during examination
Infants which had asphyxia during examination
Age
To 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
َA blinded person (supervisor) will watch the videos and will set score of the PIPP tool
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Fakouri Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2017-11-12, 1396/08/21
Ethics committee reference number
IR.MUMS.REC.1396.293
Health conditions studied
1
Description of health condition studied
Retinopathy of Permaturity
ICD-10 code
H35.1
ICD-10 code description
Retinopathy of prematurity
Primary outcomes
1
Description
Pain caused by eye exam of retinopathy of prematurity
Timepoint
Before, during and after eye exam
Method of measurement
using premature infant pain profile tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Newborn Individualized Developmental Care and Assessment Program (NIDCAP)
Category
Behavior
2
Description
Control group: Infants of the control group are under common actions which are pouring anesthetic drops into their eyes and then eye examination by RetCam digital imaging system to determine their pain score based on PIPP tool.