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Trial registered on ANZCTR


Registration number
ACTRN12618000082202
Ethics application status
Approved
Date submitted
10/01/2018
Date registered
19/01/2018
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Date results information initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a social robot on pain and behavioural and psychological symptoms in people with dementia: A pilot randomised controlled study
Scientific title
The effect of a social robot on pain and behavioural and psychological symptoms in people with dementia: A pilot randomised controlled study
Secondary ID [1] 292099 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia care 303947 0
Condition category
Condition code
Neurological 303304 303304 0 0
Dementias
Mental Health 305343 305343 0 0
Depression
Mental Health 305344 305344 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298560 0
Behaviour
Intervention code [2] 298880 0
Treatment: Devices
Comparator / control treatment
Participants allocated to the usual care group will continue their routine care (without PARO intervention), but these people will have access to PARO for two weeks after the 6-week intervention period. The usual care includes games, music concerts and massage.
Control group
Active

Outcomes
Primary outcome [1] 302683 0
Change of the pain level measured by two ways: (1) self-reports of pain measured by The Revised Iowa Pain Thermometer (IPT-R) ; (2) researcher's observation of pain behaviour using The Pain Assessment in Advanced Dementia (PAINAD).
Timepoint [1] 302683 0
Baseline and immediately post-intervention
Secondary outcome [1] 336749 0
Change of agitation being assessed by the Cohen-Mansfield Agitation Inventory – Short Form (CMAI-SF)
Timepoint [1] 336749 0
Baseline and immediately post-intervention
Secondary outcome [2] 336750 0
Change of depression being assessed by the Cornell Scale for Depression in Dementia (CSDD)
Timepoint [2] 336750 0
Baseline and immediately post-intervention
Secondary outcome [3] 336751 0
Change of anxiety being assessed by the Rating Anxiety in Dementia (RAID)
Timepoint [3] 336751 0
Baseline and immediately post-intervention
Secondary outcome [4] 336752 0
Physiological indicators (e.g. heart rate, physical activity and sleep duration being assessed by the SenseWear armband and the level of salivary cortisol).
Timepoint [4] 336752 0
Baseline and immediately post-intervention
Secondary outcome [5] 340537 0
Pain medication consumption being assessed by the Modification Quantification Scale Version III (MQS III )
Timepoint [5] 340537 0
Baseline and immediately post intervention

Eligibility
Key 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).
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation assignments will be concealed in opaque, sealed envelopes with opened sequentially when it is required to conduct the intervention activities (e.g. post-baseline data collection).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to either the PARO or usual care group via computer-generated randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
According to the previous study, it is anticipated that a total of 42 participants will be required to have a power of 0.8 to detect a significant change in pain score at an alpha level of 0.05. With a further attrition rate of 10% due to dropout, hospitalisation and death, a total of 46 (23 per group) residents will be recruited for this study.
Data analysis will be conducted using SPSS Statistics software. Ten percent of the data entry will be double checked for accuracy and consistency. Descriptive data will be used to report on the feasibility of the study. Frequency and percentages will be used for ordinal or categorical variables while mean and standard deviation will be used to describe continuous variables with normal distribution and medium for skewed distribution data. Baseline variations between intervention and control group will be tested using Chi square tests for categorical variables, t-tests for normally distributed continuous data and Mann-Whitney tests for continuous variables with skewed distribution. Multivariate Analysis of Covariance (MANCOVA) will be conducted to explore the effects of PARO compared to control group while adjusting for any significant variables at baseline. An intention-to-treat (ITT) approach where all participants will be analysed based on the treatment group in which they are randomised to, with the last observation carried forward (LOCF) will be used to manage missing data. Statistical significance will be set at the alpha level of 0.05. Qualitative data will be transcribed into NVivo 11.0 and thematic analysis will be used to explore the participants’ perceptions of using PARO for pain.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 298409 0
Other Collaborative groups
Name [1] 298409 0
China Scholarship Council and Griffith University PhD Scholarship
Address [1] 298409 0
170 Kessels Road Nathan Campus, Griffith University, Brisbane, Queensland 4111, Australia
Country [1] 298409 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Rd, Nathan campus, Griffith University, QLD,4111, Australia
Country
Australia
Secondary sponsor category [1] 297545 0
Government body
Name [1] 297545 0
China scholarship Council
Address [1] 297545 0
Xicheng Distrct, Chegongzhuang Street, No. 9 building A3 level 13, 100044, Beijing, China
Country [1] 297545 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297862 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 297862 0
170 Kessels Road Nathan Campus, Griffith University, Brisbane, Queensland 4111, Australia
Ethics committee country [1] 297862 0
Australia
Date submitted for ethics approval [1] 297862 0
21/08/2017
Approval date [1] 297862 0
21/11/2017
Ethics approval number [1] 297862 0
Ref Number: 2017/774
Ethics committee name [2] 302434 0
UnitingCare Queensland Human Research Ethics Committtee
Ethics committee address [2] 302434 0
Level 5, 192 Ann Street Brisbane QLD 4000
Ethics committee country [2] 302434 0
Australia
Date submitted for ethics approval [2] 302434 0
21/03/2018
Approval date [2] 302434 0
11/07/2018
Ethics approval number [2] 302434 0
Pu 22418

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75302 0
Prof Wendy Moyle
Address 75302 0
School of Nursing and Midwifery, 170 Kessels Rd, Nathan campus, Griffith University, QLD,4111, Australia
Country 75302 0
Australia
Phone 75302 0
+61 7 3735 5526
Fax 75302 0
Email 75302 0
w.moyle@griffith.edu.au
Contact person for public queries
Name 75303 0
Ms Lihui Pu
Address 75303 0
School of Nursing and Midwifery, 170 Kessels Rd, Nathan campus, Griffith University, QLD,4111, Australia
Country 75303 0
Australia
Phone 75303 0
+61 7 3735 7682
Fax 75303 0
Email 75303 0
lihui.pu@griffithuni.edu.au
Contact person for scientific queries
Name 75304 0
Ms Lihui Pu
Address 75304 0
School of Nursing and Midwifery, 170 Kessels Rd, Nathan campus, Griffith University, QLD,4111, Australia
Country 75304 0
Australia
Phone 75304 0
+61 7 3735 7682
Fax 75304 0
Email 75304 0
lihui.pu@griffithuni.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No permission granted from participants.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary