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ISRCTN
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ISRCTN41587583
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ClinicalTrials.gov identifier
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Public title
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Touch and Talk for Procedural Pain in Infants and Toddlers in the Paediatric Intensive Care Unit (PICU)
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Scientific title
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Maternal comfort, analgesia, regulation, endorphin-release: mothercare, a program of research for pain in critically ill infants and toddlers
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Acronym
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Touch and Talk (T&T)
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Serial number at source
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MOP-64307
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Study hypothesis
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Infants and children who are critically ill will be more physiologically stable during line removal and will have heart rates (HR) and O2 saturation rates return to baseline sooner when mothers use touch and talk (T&T) versus no maternal contact with the child.
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Lay summary
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Ethics approval
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McGill University Health Centre (full board review) approved on 20/11/2003 (ref: MCH003-48).
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Study design
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A crossover design with each child as their own control. Order of condition will be randomly assigned.
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Pain response
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Participants - inclusion criteria
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Children from full-term birth through to three years are eligible, either sex
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Participants - exclusion criteria
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1. Infants born less than full term
2. Children older than three years
3. Children receiving paralytic agents
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Anticipated start date
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01/11/2005
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Anticipated end date
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01/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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66
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Interventions
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Mothers will be taught where to sit so they can hold their child's hand during one line removal. They will be encouraged to talk to their child, either reciting nursery rhymes, signing or speaking in baby talk to children less than two years or for the other children, reading a story or talking about the child's favorite things. Then at the time of the child's line removal, the mother will provide T&T during one line removal but not the other.
The control group will receive no maternal contact.
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Primary outcome measure(s)
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Physiologic stability:
1. Maximum range of heart rate and O2 saturation from baseline throughout the procedure
2. Time to return to baseline heart rate and O2 saturation
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Secondary outcome measure(s)
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Stress response: measured through the procurement of salivary cortisol collected prior to (basal) and 30 minutes after (stress response) the heel stick procedure for both the mother and the infant
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Sources of funding
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Canadian Institutes of Health Research (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP 64307)
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Trial website
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Publications
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Contact name
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Dr
Celeste
Johnston
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Address
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3506 University Street
Room 226
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City/town
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Montreal
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Zip/Postcode
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H3A 2A7
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Country
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Canada
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Sponsor
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McGill University (Canada)
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Address
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3506 University Street
Room 226
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City/town
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Montreal
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Zip/Postcode
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H3A 2A7
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Country
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Canada
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Date applied
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26/03/2006
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Last edited
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27/03/2009
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Date ISRCTN assigned
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27/06/2006
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