Touch and Talk for Procedural Pain in Infants and Toddlers in the Paediatric Intensive Care Unit (PICU)
| ISRCTN | ISRCTN41587583 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41587583 |
| Secondary identifying numbers | MOP-64307 |
- Submission date
- 26/03/2006
- Registration date
- 27/06/2006
- Last edited
- 27/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Celeste Johnston
Scientific
Scientific
3506 University Street
Room 226
Montreal
H3A 2A7
Canada
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Maternal comfort, analgesia, regulation, endorphin-release: mothercare, a program of research for pain in critically ill infants and toddlers |
| Study acronym | Touch and Talk (T&T) |
| Study objectives | 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(s) | McGill University Health Centre (full board review) approved on 20/11/2003 (ref: MCH003-48). |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/11/2005 |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 66 |
| Key inclusion criteria | Children from full-term birth through to three years are eligible, either sex |
| Key exclusion criteria | 1. Infants born less than full term 2. Children older than three years 3. Children receiving paralytic agents |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
3506 University Street
Montreal
H3A 2A7
Canada
H3A 2A7
Canada
Sponsor information
McGill University (Canada)
University/education
University/education
3506 University Street
Room 226
Montreal
H3A 2A7
Canada
"ROR" |
https://ror.org/01pxwe438 |
|---|
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP 64307)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
