None listed
Conditions
Brief summary
Chronic pain is a common problem but often undiagnosed and untreated in people with dementia due to their cognitive impairment and limited communication ability, leading to reduced quality of life and increased healthcare costs. The efficacy and economic value of interventions to reduce pain in people with dementia remains unclear due to a lack of clinically useful pain assessment tools for this group. This study will (1) determine the feasibility of an artificial intelligence-based application (PainChek) to measure pain in people with dementia; (2) identify the optimal dosage and efficacy of a social robot (PARO) intervention; and (3) develop a checklist of cost-effectiveness measures. A sample of 45 residents with dementia will be randomly allocated to Intervention Group 1 (15-minute PARO intervention, 2×/day) or Intervention Group 2 (15-minute PARO intervention, 1×/day), or the Control Group (15-minute Plush Toy, 1×/day), for 4 weeks and follow-up at week 8. Primary outcomes include the feasibility of using the PainChek to evaluate the intervention efficacy and cost-effectiveness needs within a larger trial. Secondary outcomes are neuropsychiatric symptoms, medication use and participants’ quality of life. This novel project will improve pain management in people with dementia, and potentially reduce treatment costs.
Interventions
The PersonAl RObot (PARO) is a therapeutic robot and a non-pharmacological intervention that has no significant negative side effects. PARO has the appearance of a baby harp seal and is covered with artificial fur, which is soft and warm to touch. It has the following four senses: sight, hearing, balance and tactile senses. PARO has two optical nose sensors to recognise the source of light and has a diurnal rhythm of sleep or movement according to the light sources and stimulation of the sensors
The PersonAl RObot (PARO) is a therapeutic robot and a non-pharmacological intervention that has no significant negative side effects. PARO has the appearance of a baby harp seal and is covered with artificial fur, which is soft and warm to touch. It has the following four senses: sight, hearing, balance and tactile senses. PARO has two optical nose sensors to recognise the source of light and has a diurnal rhythm of sleep or movement according to the light sources and stimulation of the sensors. PARO also has three microphones in its ears to detect sound source direction and speech recognition, such as its name or greetings, as well as some simple words. It contains a posture sensor to maintain balance and recognises its posture when it is held by a user. For motion, it has seven silent intelligent actuators to open and close its eyes and move its neck and its front and rear flippers. Thus PARO combines these four senses to respond and communicate with users by moving or making a sound. The voice of PARO was recorded from a real baby harp seal. PARO can also learn users’ preference for its behaviour and has emotions such as happiness or anger. Taking care of PARO can make people feel happy and they may enjoy having PARO as a companion, which reflects the therapeutic effects of PARO on users. In this study, participants randomised to Intervention Group 1 will receive a 15-minute non-facilitated individual (one-on-one) PARO intervention for 2 sessions per day from Monday to Friday. Participants assigned to Intervention Group 2 will receive a 15-minute non-facilitated individual (one-on-one) PARO intervention for 1 session per day from Monday to Friday. The intervention will be three weeks and we will follow up at week 8. In each session, trained research assistants (RAs) will introduce PARO to a participant and leave the robot to the participant for 15 minutes. RAs will record the time, duration and interactions of participants with PARO for each session using an observation diary. Before and after each session, trained research assistants (RAs) will assess the pain levels of participants using the PainChek app during the three-week intervention. The RA will use a Tablet camera to capture a three-second video of the facial expressions of participants. The facial indicators of pain will be detected automatically and the RA will record other pain-related behaviours such as voice, movement, behaviour, activity and body language via the PainChek app. It takes around two minutes to complete the assessment.
Sponsors
Menzies Health Institute Queensland, Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(1) Age 65 years and older and can speak and understand English. (2) Participants must have been diagnosed with some form of dementia. (3) Participants are assumed to experience chronic pain if they report and have regular pain medication. (4) Demonstration of sensation and perception to allow interaction with PARO. (5) Living in the care facility for more than 3 months.
Exclusion criteria
(1) Diseases such as acute exacerbation of chronic obstructive pulmonary disease that requires residents to be admitted to hospital frequently; (2) Terminal illnesses where the resident is in the final palliative stage; (3) A diagnosis of a major mental illness, such as schizophrenia; and (4) Infectious diseases, such as acquired immune deficiency syndrome, COVID-19, or tuberculosis, or an open wound that is unable to be covered.
Outcome results
None listed