Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-01-09 @ 11:29 PM
Study NCT ID:
NCT05039918
Status:
UNKNOWN
Last Update Posted:
2021-09-10
First Post:
2021-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neonatal Experience of Social Touch
Sponsor:
Liverpool John Moores University
Organization:
Study Overview
Official Title:
The Healing Power of Touch: Investigation of a Peripheral Neurological Mechanism for Reducing Pain and Enhancing Neurodevelopmental Outcomes
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEST
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 291417 | OTHER | IRAS | View |