Infant Development, Pain, Premature Birth
Conditions
Keywords
CT Fibres, Affective touch
Brief summary
The purpose of this randomised control trial is to determine the efficacy of CT-optimal touch (gentle stroking at 3cm/s) for newborn's who require a heel prick.
Detailed description
Newborn infants are subject to several novel experiences that cause physiological, biochemical and behavioural indicators of stress; even routine and common events such as handling, changing a diaper or being bathed can increase salivary cortisol levels. Excluding surgery and mechanical ventilation, the most common procedural pain sources in newborns are heel-lancing and venepuncture. Tactile interventions such as skin to skin care and 'still containment hold' are widely used in clinical care with apparent positive results such as lower mean respiratory heart rate and pain measures, and higher oxygen saturation; yet, dynamic touch interventions have reported to be more beneficial than static touch interventions. A distinct type of nerve fibres, CT (C tactile) afferents, found exclusively in hairy skin, that respond optimally to gentle stroking at a velocity of \ 1-10cm/s, are part of a system for processing pleasant and social rewarding touch. CT fibre activation also plays a role in pain inhibition and may be linked to the development of self-regulation, thereby, serving a neuroprotective function for the developing infant brain. Here we will investigate whether tactile stimulation at CT-optimal velocity will reduce biochemical and physiological indicators of stress in infants, as determined by salivary cortisol, heart rate and blood oxygenation levels.
Interventions
BEHAVIORALAffective touch
Gentle stroking at CT-optimal speed
Sponsors
Liverpool Women's NHS Foundation Trust
Liverpool John Moores University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Allocation sequence will be randomised in advance by a trusted member of LJMU staff who is not involved in the study, using a computerised website to generate random numbers. The sequences will be placed in sealed opaque envelopes and stored in a secure location on-site. The use of an off-site computerised system for group allocation will decrease the risk of allocation bias. Eligible infants whose person(s) with parental responsibility have provided consent will be assigned the next available envelope which will be accessed by the lead researcher prior to the intervention.
Eligibility
Sex/Gender
ALL
Age
35 Weeks to 42 Weeks
Healthy volunteers
Yes
Inclusion criteria
* The infant is born between 35 and 42 weeks. * Require a heel prick * Infants may be treated with antibiotics. * Infants may be supported with non-invasive respiratory support. * Infants may require blood sugar monitoring. * Infants may be monitored for jaundice or infection. * Written consent has been obtained from the person(s) with parental responsibility.
Exclusion criteria
* Have a history of neurological problems. * Receiving pharmacological analgesics. * Known genetic condition. * Breastfed babies * Admitted to high dependency or intensive care * Invasive respiratory support * Receiving parenteral nutrition * Has received any treatment for seizures * Clinical instability in the judgment of nurses/midwives and paediatricians looking after the baby and mother.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary cortisol | Immediately before heel prick and 20 minutes after | Change between cortisol levels at baseline and 20 minutes after |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | Baseline, time of event, 20 mins after and 60 minutes after | Change from baseline heart rate to to time of event and two post test periods |
| Blood oxygenation | Baseline, time of event, 20 mins after and 60 minutes after | Change from baseline oxygenation levels to time of event and two post test periods |
Countries
United Kingdom
Contacts
Primary ContactFrancis McGlone, Professor
Backup ContactLaura Mulligan
Outcome results
None listed