Human factors validation and acceptability of Gentle Touch Stimulator
Research type
Research Study
Full title
Missing Touch 1: Human factors validation and acceptability testing of a neuro-engineered C-tactile stimulation device.
IRAS ID
303457
Contact name
Mark Turner
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
0 years, 2 months, 0 days
Research summary
Summary of Research
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 (700 - 900 mb). 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. \n\nThe 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 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
Summary of Results
Infants in the Neonatal Intensive Care Unit experience fewer positive tactile interactions compared to healthy full-term infants. Touch plays a critical role in infant development by stimulating tactile afferent nerve fibres, which are associated with calming, bonding, and potentially neuroprotective mechanisms. This study aimed to evaluate the tolerability and acceptability of a medical device that simulates dynamic touch (gentle stroking) in a small cohort of healthy participants prior to a larger efficacy trial. The research assessed whether neonates could tolerate being placed on the device for 10 minutes while it was in operation. Tolerance was assessed by monitoring heart rate data alongside behavioural signs of distress. Results demonstrated that heart rate decreased from baseline during device activation in all but one participant, and this decrease persisted into the washout phase.
Semi-structured interviews with parents and clinicians were conducted to evaluate the device's acceptability in a clinical environment. Additionally, clinicians completed a questionnaire assessing perceived usefulness, ease of use, and behavioural intention to use the device.
Findings from clinicians' questionnaires and interviews indicated generally good acceptability, with particularly high ratings for ease of use and initial impressions. Clinician interviews provided further insights, revealing unanimous agreement that infants appeared comfortable on the mattress. Over half of clinicians noted, unprompted, the potential benefits to the department. However, concerns were raised about noise levels, the size of the control unit, infection control measures, and whether the device might be perceived as a replacement for skin-to-skin contact.
Parents expressed overall acceptance, with positive feedback from all participants and raised no safety concerns. Comments highlighted infant comfort, sleep induction, and support for the concept. The main suggestions were to reduce the number of wires and noise.
Results suggest that infants can tolerate the mattress, and with further development and clear guidelines, both parents and clinicians in neonatal settings would likely find the device acceptable. Efficacy was not measured in this study.
Our research team acknowledges that nurturing care and tactile stimulation are best provided by caregivers, and that this device is intended as an alternative when these options are unavailable or reduced. The findings of this study will be included in the researcher’s PhD thesis. Participating families will be informed of the results, which may also be presented at conferences or published in medical journals. We sincerely thank the families who contributed to this research.
REC name
North of Scotland Research Ethics Committee 1
REC reference
22/NS/0083
Date of REC Opinion
3 Jul 2022
REC opinion
Favourable Opinion