Protocol summary

Summary
The purpose of the study is to examine the effect of multisensory stimulation on the pain caused by eye examination in an attempt to administer screening examinations for retinopathy of prematurity. In this randomized clinical trial, 80 preterm infants with a gestational age of 32 weeks or less based on baby’s records, and infants who weigh less than 1500 gr at birth, or infants who weigh 1500 to 2000 gr and suffer from a severe systematic disease and age 4 weeks, were selected by an available sampling, and randomly divided into two groups; intervention and control. In the intervention group, a multisensory stimulation program runs. For tactile stimulation, baby’s face, upper and lower limbs will be gently caressed by her mother. For visual stimulation, mother takes a close look at baby’s face and attempts to make eye contact with her. For auditory stimulation, mother gently and continuously talks to her baby. For olfactory stimulation, the smell of vanilla will be used; which runs 15 minutes before examination starts and lasts until the examination starts. For gustatory stimulation, 33% glucose was used 2 minutes before examination starts. The control group received ordinary care in the ward. PIPP was used for pain assessment tool, the pain was examined in eight stages before intervention, before examination starts, during first eye and second eye examination, and in 4 30-second stages immediately after the end of eye examination.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014100119359N1
Registration date: 2015-01-02, 1393/10/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-02, 1393/10/12
Registrant information
Name
Hossein Zeraati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3151 0000
Email address
zeraatih911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2014-07-05, 1393/04/14
Expected recruitment end date
2014-09-06, 1393/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of multisensory stimulation on pain of screening eye examination for retinopathy of prematurity in preterm neonates
Public title
Effect of multisensory stimulation on pain of eye examination in preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: preterm infants with a gestational age of 32 weeks or less based on baby’s records, and infants who weigh less than 1500 gr at birth, or infants who weigh 1500 to 2000 gr and suffer from a severe systematic disease and age 4 weeks, in the presence of her mother. Baby is kept in a quiet and alert situation, her 5-minute Apgar score should not less than 6, and she has not taken any hypnotic drug within last 24 hours. Exclusion criteria: during examination, baby seems to be in need of CPR, and she exhibits apnea symptoms.
Age
From 20 days old to 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
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 Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Building Qureshi, Daneshgah Street, Doctora Crossroads, Mashhad
City
Mashhad
Postal code
Approval date
2014-07-05, 1393/04/14
Ethics committee reference number
research/930010/1/1030

Health conditions studied

1

Description of health condition studied
preterm infant
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants

Primary outcomes

1

Description
Pain score
Timepoint
Before intervention, before the eye examination, during the first eye examination, during the second eye examination, 4 stage 30 seconds after the eye examination
Method of measurement
Premature Infant Pain Profile tool

2

Description
Heart rate
Timepoint
Before intervention, before the eye examination, during the first eye examination, during the second eye examination, 4 stage 30 seconds after the eye examination
Method of measurement
Pulse oximetry

3

Description
Oxygen saturation
Timepoint
Before intervention, before the eye examination, during the first eye examination, during the second eye examination, 4 stage 30 seconds after the eye examination
Method of measurement
Pulse oximetry

4

Description
Behavioral condition
Timepoint
Before intervention, before the eye examination, during the first eye examination, during the second eye examination, 4 stage 30 seconds after the eye examination
Method of measurement
premature infant pain profile tool

5

Description
Facial expression
Timepoint
Before intervention, before the eye examination, during the first eye examination, during the second eye examination, 4 stage 30 seconds after the eye examination
Method of measurement
premature infant pain profile tool

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, multisensory stimulation program is implemented. For tactile stimulation, face, upper and lower limbs of infant will be stroking by the mother as a gentle. For visual stimulation, the baby's mother look closely and try to make eye contact with infant. For auditory stimulation, the baby's mother speaks slowly and continuously sustained with infant. For smell stimulation, vanilla will be used. This stimulation is applied 15 minutes before the start of the examination to start of examination. To stimulate the taste, the glucose of 33% was used 2 minutes before the examination
Category
Other

2

Description
The control group received usual care involves placing the baby in a relaxed environment before the examination.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam-al-Anbia Hospital
Full name of responsible person
Hamidreza Behnam Vashani
Street address
Gharani boulevard, Mashhad.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Doctor Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Building Qureshi, Daneshgah Street, Doctora Crossroads, Mashhad , Iran
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Zeraati
Position
Master of Sciences in Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doctora Crossroads, Mashhad Mashhad
City
Mashhad
Postal code
Phone
+98 51 5523 5771
Fax
Email
zeraatih@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Behnam Vashani
Position
Master of Science in Nursing, Faculty member of School of Nursing and Midwifery, Mashhad, Iran
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doctora Crossroads, Mashhad , Iran
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
behnamhr@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Zeraati
Position
Master of student in Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doctora Crossroads, Mashhad , Iran
City
Mashhad
Postal code
Phone
+98 51 5523 5771
Fax
Email
zeraatih@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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