Protocol summary
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Study aim
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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
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Design
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A randomized clinical trial with crossover design
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Settings and conduct
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Neonatal Intensive Care Unit (NICU) at Valiasr hospital in Tehran, Iran
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Participants/Inclusion and exclusion criteria
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Hospitalized neonates with gestational age 28-36 weeks who were anticipated to have at least six heel sticks during the NICU hospitalization
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Intervention groups
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No pain relief method, oral dextrose, and facilitated tucking
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Main outcome variables
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Pain measured by The Premature Infant Pain Profile (PIPP)
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2014-09-08, 1393/06/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Maternal and Fetal Research Center
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Expected recruitment start date
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2014-08-23, 1393/06/01
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Expected recruitment end date
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2014-12-21, 1393/09/30
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Actual recruitment start date
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2015-03-14, 1393/12/23
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Actual recruitment end date
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2016-11-20, 1395/08/30
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Trial completion date
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2017-02-15, 1395/11/27
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Scientific title
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The effect of oral dextrose and facilitated tucking in reducing pain associated with arterial blood sampling in preterm infants
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Public title
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Effect of pain relief methods blood sampling pain in newborns
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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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:
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Age
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From 28 months old to 36 months old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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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
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The statistician was not present in patient enrollment, and the data collector was not involved in data analysis
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Placebo
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Not used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2014-05-19, 1393/02/29
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Ethics committee reference number
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25966
Health conditions studied
1
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Description of health condition studied
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Acute Pain
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ICD-10 code
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R52.0
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ICD-10 code description
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Primary outcomes
1
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Description
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Pain
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Timepoint
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before of intervention, during and after of intervention
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Method of measurement
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Premature Infant Pain Profile
Secondary outcomes
1
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Description
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Feasibility
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Timepoint
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After Intervention
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Method of measurement
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Questioning about simplicity and the applicability
Intervention groups
1
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Description
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Intervention 1/ Oral Dextrose solution, 0.5 ml of 50 % dextrose by a syringe 2 minutes before the procedure
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Category
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Other
2
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Description
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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
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Category
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Other
3
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Description
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Control, conducting procedure based on hospital protocol without any pain relief intervention except the application of gentle touching and verbal comfort
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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All of the individual participant data collected during the trial, after deidentification
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When the data will become available and for how long
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Immediately following publication. No end date.
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To whom data/document is available
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Anyone who wishes to access the data.
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Under which criteria data/document could be used
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To gain access, data requestors will need to sign a data access agreement. The data is available for any purpose.
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From where data/document is obtainable
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All applications should be sent to athare_ranjbar@yahoo.com
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What processes are involved for a request to access data/document
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All requests will be answered within a maximum of one month by email.
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Comments
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