Human Factors Validation and Acceptability Testing of a Stimulation Device

CompletedOBSERVATIONAL
Enrollment

34

Participants

Timeline

Start Date

January 5, 2024

Primary Completion Date

April 30, 2024

Study Completion Date

February 2, 2025

Conditions
Human FactorsAcceptabilityTolerance
Interventions
DEVICE

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."

OTHER

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.

Trial Locations (3)

L3 3AF

Liverpool John Moores University, Liverpool

L8 7SS

Liverpool Womens Hospital Trust, Liverpool

Unknown

University of Liverpool, Liverpool

All Listed Sponsors
collaborator

Liverpool John Moores University

OTHER

collaborator

Liverpool Women's NHS Foundation Trust

OTHER

lead

University of Liverpool

OTHER

NCT06659978 - Human Factors Validation and Acceptability Testing of a Stimulation Device | Biotech Hunter | Biotech Hunter