Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MOP-64307
Study information
Scientific title
Maternal comfort, analgesia, regulation, endorphin-release: mothercare, a program of research for pain in critically ill infants and toddlers
Acronym
Touch and Talk (T&T)
Study hypothesis
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.
Ethics approval
McGill University Health Centre (full board review) approved on 20/11/2003 (ref: MCH003-48).
Study design
A crossover design with each child as their own control. Order of condition will be randomly assigned.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pain response
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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
Secondary outcome measures
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
Overall trial start date
01/11/2005
Overall trial end date
01/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Children from full-term birth through to three years are eligible, either sex
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
66
Participant exclusion criteria
1. Infants born less than full term
2. Children older than three years
3. Children receiving paralytic agents
Recruitment start date
01/11/2005
Recruitment end date
01/12/2006
Locations
Countries of recruitment
Canada
Trial participating centre
3506 University Street
Montreal
H3A 2A7
Canada
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP 64307)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list