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Protocol summary

Study aim
This study aimed to compare the efficacy of oral Dextrose and the use of facilitated tucking on the pain caused by blood sampling in preterm infants
Design
A randomized clinical trial with crossover design
Settings and conduct
Neonatal Intensive Care Unit (NICU) at Valiasr hospital in Tehran, Iran
Participants/Inclusion and exclusion criteria
Hospitalized neonates with gestational age 28-36 weeks who were anticipated to have at least six heel sticks during the NICU hospitalization
Intervention groups
No pain relief method, oral dextrose, and facilitated tucking
Main outcome variables
Pain measured by The Premature Infant Pain Profile (PIPP)

General information

Reason for update
Due to the long time of hospitalization of neonates in the NICU, the recruitment of three parallel groups was very difficult. Also, the response of children to pain is very different and the comparison of three methods in all subjects can eliminate these differences, therefore considering the non-invasive nature of interventions (Oral Dextrose and Positioning), both methods were used by a cross-over method. Three groups with twenty subjects were included in the study with different orders in interventions (Control, Oral Dextrose, and Positioning). The age limit inclusion criteria changed from 32 -36 weeks based on the definition of the premature neonate.
Acronym
IRCT registration information
IRCT registration number: IRCT201408029568N9
Registration date: 2014-09-08, 1393/06/17
Registration timing: prospective

Last update: 2019-10-16, 1398/07/24
Update count: 1
Registration date
2014-09-08, 1393/06/17
Registrant information
Name
Golnaz Rezaeizadeh
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
mfnhrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Maternal and Fetal Research Center
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
2015-03-14, 1393/12/23
Actual recruitment end date
2016-11-20, 1395/08/30
Trial completion date
2017-02-15, 1395/11/27
Scientific title
The effect of oral dextrose and facilitated tucking in reducing pain associated with arterial blood sampling in preterm infants
Public title
Effect of pain relief methods blood sampling pain in newborns
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of asphyxia at birth based on infant records Birth age of 2–28 days Anticipated to have at least six heel sticks during the NICU hospitalization No administration of sedatives relaxants, antiepileptic, or analgesic in 24 hours before every study session Born to mothers with no history of addiction to substances Not having any acute condition which required more critical care surgery Not using of sedative, relaxants, antiepileptic, or analgesic drugs
Exclusion criteria:
Age
From 28 months old to 36 months old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 3
Control, Oral Glucose, facilitated tucking
Actual sample size reached: 60
More than 1 sample in each individual
Actual sample size in each individual: 3
Control, Oral Glucose, facilitated tucking
Randomization (investigator's opinion)
Randomized
Randomization description
Infants with inclusion criteria were randomly allocated to three groups (A, B and C) by permutated blocks of six. Six blocks were defined (ABC, ACB, BAC, BCA, CAB and CBA) and a number from 1 to 6 were assigned to each block. By rolling dice the sequence of blocks was determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistician was not present in patient enrollment, and the data collector was not involved in data analysis
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences/Research Center for Maternal and newborn baby
Street address
Research Center for Maternal and newborn baby-Second Floor-Asr Hospital-Gharib Street- Keshavarz Street
City
Tehran
Province
Tehran
Postal code
1416753955
Approval date
2014-05-19, 1393/02/29
Ethics committee reference number
25966

Health conditions studied

1

Description of health condition studied
Acute Pain
ICD-10 code
R52.0
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
before of intervention, during and after of intervention
Method of measurement
Premature Infant Pain Profile

Secondary outcomes

1

Description
Feasibility
Timepoint
After Intervention
Method of measurement
Questioning about simplicity and the applicability

Intervention groups

1

Description
Intervention 1/ Oral Dextrose solution, 0.5 ml of 50 % dextrose by a syringe 2 minutes before the procedure
Category
Other

2

Description
Intervention 2/ The facilitated tucking placing infants on their side, with their back gently bent, and their legs were in a flexion angle of greater than 90 degrees
Category
Other

3

Description
Control, conducting procedure based on hospital protocol without any pain relief intervention except the application of gentle touching and verbal comfort
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Valisasr Hospital
Full name of responsible person
Athareh Ranjbar
Street address
Chamran, East, Highway, Baqerkhan St
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6659 1316
Email
athare_ranjbar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mamak Shariat
Street address
Second Floor, Asr Hospital, Imam Khomeini Complexex, Gharib Street, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6659 1316
Email
mshariat@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/Asr hospital
Full name of responsible person
Athareh Ranjbar
Position
Master of Nursing/ Health Education Supervisor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Second Floor, Asr Hospital, Imam Khomeini Hospital Complexex, Gharib Street, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6694 0020
Fax
Email
athare_ranjbar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nikoo Niknafs
Position
Assistant Professor/Neonatologist
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Second Floor, Asr Hospital, Imam Khomeini Complexex, Gharib Street, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6691 2357
Fax
Email
nikoo.niknafs@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences/Maternal Fetal Neonatal Research Center
Full name of responsible person
Athareh Ranjbar
Position
Master of nursing/ Health Education Supervisor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Second Floor, Asr Hospital, Imam Khomeini Complexex, Gharib Street, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6694 0020
Fax
Email
athare_ranjbar@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All of the individual participant data collected during the trial, after deidentification
When the data will become available and for how long
Immediately following publication. No end date.
To whom data/document is available
Anyone who wishes to access the data.
Under which criteria data/document could be used
To gain access, data requestors will need to sign a data access agreement. The data is available for any purpose.
From where data/document is obtainable
All applications should be sent to athare_ranjbar@yahoo.com
What processes are involved for a request to access data/document
All requests will be answered within a maximum of one month by email.
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