Feasibility study protocol of the PainChek app to assess the efficacy of a social robot intervention for people with dementia

Aim: This study aims to test the feasibility of the PainChek app to assess pain for people with dementia living in residential aged care facilities (RACFs). It will also identify the optimal dosage and efficacy of a social robot (personal assistant robot [PARO]) intervention on chronic pain for people with dementia. Design: This is a feasibility randomized controlled trial with three groups. Methods: Forty-five residents living with dementia and chronic pain will be recruited from one RACF. The intervention consists of an individual 15-min non-facilitated session with a PARO robot twice a day (Group 1), a PARO robot once a day (Group 2), or a Plush-Toy (non-robotic PARO) once a day (Group 3) from Monday to Friday for 4 weeks. Participants will be followed at 4 and 8 weeks after baseline assessments. The primary outcome will be the feasibility of using the PainChek app to measure changes in pain levels before and after each session. Secondary outcomes include staff-rated pain levels, neuropsychiatric symptoms, quality of life and changes in psychotropic and analgesic medication use. Participants, staff and family perceptions of using PARO and the PainChek app will be collected after the 4-week intervention. Discussion: This study will test the use of the PainChek app and PARO to improve pain management for people with dementia. Results from this study will help determine its usefulness, feasibility and acceptability for pain management in people with dementia living in RACFs. Impact: As pain is a significant problem for people with dementia, this project will generate evidence on the use of the PainChek to measure the efficacy of a social robot intervention that has the potential to improve the quality of pain care in people with dementia. Trial Registration: Australian and New Zealand Clinical Trials Registry number (ACTRN12621000837820) date registered 30/06/2021.