Human Factors Validation and Acceptability Testing of a Stimulation Device

NCT06659978 | Completed

• 1 other identifier: UoL001661
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 3

Brief Summary

Our team have developed a mattress topper, consisting of rubber tubes attached side to side that are deflated and inflated, mimicking dynamic touch and optimal CT stimulation (3cm/s). It is connected to a microprocessor control unit and a vacuum supply. By controlling the interval between the vacuum applied to each tube in the device it generates a flow sequence as each tube relaxes back to its original state. This will feel like a stroking across the skin - but non-frictional, thereby minimising the risk of friction related skin damage. The device is placed on top of a standard mattress in a neonatal cot. It has been manufactured in line with European Union (EU) safety requirements. It has been calibrated to mimic optimal CT fibre activation at 3cm/s, in line with previous touch intervention studies (Gursul et al., 2018; Manzotti et al., 2019). The device is made from silicone and is fully waterproof. A cleaning protocol will be implemented between each use for infection control. The waterproof sheet will be covered by a standard cot sheet.

Conditions

Human Factors; Acceptability; Tolerance

Outcome Measures

Primary Outcomes (1)

• Infant device tolerance

  Infant's physiological responses to the device are measured by heart rate and blood oxygenation

  25 minutes

Secondary Outcomes (2)

• Infant comfort levels

  25 minutes

• Parental and clinical staff acceptability

  15 minutes

Study Arms (1)

Infants

Well, infants born between 34 and 42 weeks.

Device: Device tolerance; Other: Acceptability questionnaire

Interventions

Device tolerance DEVICE

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.

Infants

Acceptability questionnaire OTHER

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.

Infants

Eligibility Criteria

• Age: 34 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Well infant born between 34 and 42 weeks in the low dependency unit or postnatal ward.

You may qualify if:

• Infant is born between 34- and 42-weeks gestational age.
• Infant an in-patient at LWH based on the low dependency unit or post-natal ward.
• Infant is born from a low-risk pregnancy with no concerns identified antenatally or postnatally.
• Infant has been identified as eligible by neonatal clinician (junior doctor or advanced neonatal nurse practitioner).
• Written consent has been obtained from the person(s) with parental responsibility.
• Infant has been normoglycaemic since birth or for at least 24 hours.

You may not qualify if:

• Known genetic condition or undergoing investigation for a suspected genetic condition.
• Previously admitted to high dependency or intensive care.
• Has received invasive respiratory support.
• Has received any treatment for seizures.
• Is receiving phototherapy.
• Is receiving caffeine.
• Needing any support for thermoregulation (in incubator or using "hot cot")
• Clinical instability in the judgment of nurses/midwives and paediatricians looking after the baby and mother.

Sponsors & Collaborators

• University of Liverpool: lead
• Liverpool John Moores University: collaborator
• Liverpool Women's NHS Foundation Trust: collaborator

Study Sites (3)

Liverpool John Moores University

Liverpool, L3 3AF, United Kingdom

Location

Liverpool Womens Hospital Trust

Liverpool, L8 7SS, United Kingdom

Location

University of Liverpool

Liverpool, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: January 5, 2024
• Primary Completion: April 30, 2024
• Study Completion: February 2, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)