34
Participants
Start Date
January 5, 2024
Primary Completion Date
April 30, 2024
Study Completion Date
February 2, 2025
Device tolerance
"After being fed (breastmilk or formula), video will be turned on and the infant is placed on the Gentle Touch Stimulator (GTS) in deactivated mode. After a baseline period of 5- minutes the device will be activated. It will be deactivated after 10 minutes or earlier if there are any signs of distress from the infant. A 10-minute washout observation period will be followed.~Higher levels of comfort will be considered as fewer instances of stress behaviours. The sessions will be videoed, and coded at a later date using Observation of infant behaviours."
Acceptability questionnaire
Parental and clinical staff acceptability of the device assessed by interviewing person(s) of parental responsibility and clinicians involved in the trial. Interviews will be conducted by researcher following the intervention.
Liverpool John Moores University, Liverpool
Liverpool Womens Hospital Trust, Liverpool
University of Liverpool, Liverpool
Liverpool John Moores University
OTHER
Liverpool Women's NHS Foundation Trust
OTHER
University of Liverpool
OTHER