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Investigating the effect of multisensory stimulation and breast milk on intensity of pain In premature infants during examination for retinopathy screening

Protocol summary

Study aim
Investigating the effect of multisensory stimulation and breast milk on intensity of pain In premature infants during examination for retinopathy of prematurity
Design
A clinical trial with a control group and two intervention groups, including multi-sensory stimuli group and breast milk group, randomized, blinded
Settings and conduct
This randomized, single-blind randomized clinical trial will evaluate non-pharmacological interventions on neonatal pain severity during premature retinopathy examination in the NICU ward of Shahid Sadoughi Hospital in Yazd, with three groups, one control group and two intervention groups, including multi-sensory stimulation and breast milk.
Participants/Inclusion and exclusion criteria
Premature neonates born with a fetal age of 32 weeks and 6 days or less, or weighing 1,500 grams or less, or babies weighing between 1500 and 2000 grams with a course of unstable clinical conditions, admitted to Level 3 Neonatal Intensive Care Unit, who require retinopathy examination.
Intervention groups
The first group, the intervention group of multi-sensory stimuli, are included visual, taste, tactile, auditory and olfactory sensations in the neonate prior to examination. The second group, the breast milk Intervention group, will receive two cc of breast milk with a syringe , prior to examination . The third group, the control group, no intervention for the infant are taken.
Main outcome variables
Severity of pain, arterial oxygen saturation, heart rate, behavioral changes, facial changes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180310039023N1
Registration date: 2020-01-08, 1398/10/18
Registration timing: retrospective

Last update: 2020-01-08, 1398/10/18
Update count: 0
Registration date
2020-01-08, 1398/10/18
Registrant information
Name
Kobra Mobashery zade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3263 2518
Email address
k.mobasheri@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
2018-06-24, 1397/04/03
Actual recruitment end date
2019-01-09, 1397/10/19
Trial completion date
2019-01-09, 1397/10/19
Scientific title
Investigating the effect of multisensory stimulation and breast milk on intensity of pain In premature infants during examination for retinopathy screening
Public title
Investigating the effect of multisensory stimulation and breast milk on intensity of pain In premature infants in examination retinopathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Premature neonates born with a fetal age of 32 weeks and 6 days or less, or weighing 1,500 grams or less, or babies weighing between 1500 and 2000 grams, accompanied by a period of unstable clinical conditions that lasted 4 weeks after birth The baby is checked for the first time The baby is fed one hour before the examination and no longer fed The baby looks calm and alert. Parents' written and informed consent to study agreement of the doctor who do examine
Exclusion criteria:
The baby has a history of surgery and cardiopulmonary resuscitation, and lung hemorrhage Apgar 5 minutes less than 6 Painkillers have been prescribed for the baby for the past 24 hours The baby needs to have a positive pressure and tracheal tube ventilation The baby has abnormalities and problems with the nervous system, heart and respiratory system Babies who should not be fed(n.p.o)
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 90
Actual sample size reached: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible infants are selected by Purpose-based sampling, and then assigned to one of three study groups by drawing method. The person who is unaware of the study will pick up one of the three numbers 1, 2 and 3 from the envelope
Blinding (investigator's opinion)
Single blinded
Blinding description
For the purpose of a single-blind study, individuals who are tasked with recording heart rate, oxygen saturation, and changes in face and behavior are blinded to the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
Shahid Sadughi
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2018-05-16, 1397/02/26
Ethics committee reference number
IR.SSU.REC.1397.018

Health conditions studied

1

Description of health condition studied
Pain Of Examination For Retinopathy
ICD-10 code
H35.1
ICD-10 code description
Retinopathy of prematurity

Primary outcomes

1

Description
Intensity Of Pain
Timepoint
During Eye Examination For Retinopathy
Method of measurement
PIPP Tool

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, after stabilization of infant’s condition,the intervention including a multi sensory stimulation program (visual, taste, tactile, and smell stimulation)will be performed. At first, the infant is placed at supine position,and the hands and legs are bent as the fetal position,so that the infant could move freely.For tactile stimulation, face, upper and lower limbs of infant is gently touched by the mother. The intervention is performed from 15 minutes before the beginning examination until the time of examination .For visual stimulation, the infant’s mother will be asked to look at her baby from near and try for eye communication in order to attract the infant’s attention. The intervention is performed from 15 minutes before the beginning examination until the time of examination .For hearing stimulation, the infant’s mother will be asked to speak with her baby gently and continuously. The intervention is performed from 15 minutes before the beginning of examination until the time of examination . lavender essential oil 2% is used for smell stimulation. The researcher stains a piece of sterile gauze with 5 drops of it and clamps into the infant dress .. The intervention will be performed from 15 minutes before the beginning of examination until the time of examination.1 ml of 33% glucose solution will be used for taste stimulation. glucose solution will be drawn into a syringe by the researcher. The syringe mouth without needle will be placed into the infant’s mouth and the solution will be injected into the infant’s mouth with gentle movements along with infant’s sucking for 30 seconds. This intervention starts 2 minutes before the examination. The mother will be instructed by the researcher before the intervention is performed. The procedure will be followed in a coordinated and similar manner, so that all mothers will do the same.
Category
Other

2

Description
Intervention group(breast milk) : 2 ml of breast milk is drawn by the researcher into the syringe in 2 minutes before examination and poured into the baby's mouth gently for 30 seconds.
Category
Other

3

Description
Control group: The control group will receive no intervention, and routine care, including incubation and Nidcap care( neonatal individualized developmental care assessment plan), will be performed by mothers and staff on a regular and unplanned basis.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid sadughi hospital
Full name of responsible person
Dr Soleimani
Street address
Shahid ghandi Blvd, Ebn sina Blvd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
Sadoghi-hospital@ssu.ac.ir
Web page address
https://www.ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
ِِDr Mirjalily
Street address
Shahid Sadughi
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Fax
+98 35 3724 0171
Email
info@ssu.ac.ir
Web page address
https://www.ssu.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
1
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
Yazd University of Medical Sciences
Full name of responsible person
Khadije Dehghani
Position
Instructor and faculty member of Shahid Sadoughi Faculty of Nursing and Midwifery, Yazd
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bou Ali
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Fax
+98 35 3824 1751
Email
dehghanish@ssu.ac.ir
Web page address
https://www.ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Khadije Dehghani
Position
Instructor and faculty member of Shahid Sadough
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bu Ali
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Fax
+98 35 3824 1751
Email
dehghanish@ssu.ac.ir
Web page address
https://www.ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Kobra Mobashery zade
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bu Ali
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Fax
+98 35 3824 1751
Email
mobasherzade1360@gmail.com
Web page address
https://www.ssu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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