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The effect of a social robot on pain and behavioural and psychological symptoms in people with dementia: A pilot randomised controlled study

The effect of a social robot on pain and behavioural and psychological symptoms in people with dementia: A pilot randomised controlled study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000082202
Enrollment
43
Registered
2018-01-19
Start date
2018-02-19
Completion date
2018-11-02
Last updated
2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

As pain is a disturbing problem for people living with dementia, pharmacological approaches are necessary for pain management, but medications may bring undesirable side effects; however, non-pharmacological interventions have been recommended to manage pain without obvious side effects. Among them, social robot intervention such as PARO is promising to reduce pain and it is convenient for both health care providers and patients, especially for people with dementia. Findings from this study may provide an evidence-based intervention to improve pain management thus improving the quality of life for people with dementia and decreasing the care burden for nursing staff as well as family carers.

Interventions

PARO, a therapeutic robot, is a non-pharmacological intervention which 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

PARO, a therapeutic robot, is a non-pharmacological intervention which 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 for a companion, which reflects the therapeutic effects of PARO on users. In this study, participants allocated to the intervention group will receive an individual 6-week social robot (PARO) intervention daily from Monday to Friday. In each session, the researcher will introduce PARO to a resident and leave the robot to the participant for 30 minutes. The Observed Emotion Rating Scale (OERS) will be completed on Wednesday each week by the student researcher to observe the interactions of participants with PARO . Five domains including pleasure, anger, anxiety/fear, sadness as well as general alertness will be recorded on the basis of ten-minute observations.

Sponsors

Griffith University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

(1) Aged 65 years and older who can understand and speak English or Mandarin. (2) Participants must have been diagnosed with some form of dementia or probable diagnosis of dementia by staff. (3) Being prescribed pain medications or an indication of pain (intensity * frequency greater than or equal to 2) according to two questions about pain intensity and frequency from the Minimum Data Set of the Resident Assessment Instrument (MDS-RAI)-pain scale. For those who cannot self-report pain, proxy pain reports of residents in the previous week will be obtained. (4) Display of at least one of the sensory characteristics, e.g., vision, hearing or touch; and (5) Living in a care facility for more than 3 months (to avoid the potential anxiety and distress caused by a new environment).

Exclusion criteria

(1) Diseases such as acute exacerbation of chronic obstructive pulmonary disease or renal failure that requires admission to the hospital frequently. (2) Terminal illnesses such as advanced cancer where the patient is in the final palliative stage. (3) A diagnosis of a major mental illness such as schizophrenia. (4) Infectious diseases such as AIDS or tuberculosis or wounds that cannot be adequately covered.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 28, 2026