Human Factors Validation and Acceptability Testing of a Stimulation Device

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.