Condition category
Pregnancy and Childbirth
Date applied
26/03/2006
Date assigned
27/06/2006
Last edited
27/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Celeste Johnston

ORCID ID

Contact details

3506 University Street
Room 226
Montreal
H3A 2A7
Canada

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 measures

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

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

Sponsor information

Organisation

McGill University (Canada)

Sponsor details

3506 University Street
Room 226
Montreal
H3A 2A7
Canada

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes