National Tainan Junior College of Nursing
Phase: NA
Conditions: Dementia, Mild, Dementia Moderate, Cognitive Impairment
Sponsor: National Tainan Junior College of Nursing

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National Tainan Nursing College Research Project Application Form 
Title 
Chinese 
PARO 團體介入對失智症長者之神經生物、認知功能和心理
健康的變化 
English 
Effect of the Group-based Paro Intervention on Neurobiology, 
Cognitive Function, and Mental well-being on older adults with 
dementia 
Principle investigator Shu-Chuan Chen 
Position 
Assistant Professor 
Department 
Department of Nursing 
Team of research 
Position 
Nation 
Affiliation 
department 
Assistant 
Professor 
Shu-Chuan 
Chen 
National 
Tainan Junior 
College of 
Nursing 
Department of 
Nursing 
Physician/ 
Assistant 
Professor 
Wei-Hung 
Chang 
National 
Cheng Kung 
University 
Hospital 
Department of 
Psychiatry/ 
College of 
Medicine 
Registered 
Nurse 
Chun-O Chien 
 
National 
Cheng Kung 
University 
Hospital 
Department of 
Nursing, 
 
 
 
 
 
 
 
 
Contact mobile 
(ext)707 
(Mobile) 0979885339 
(e-mail)sandra@ntin.edu.tw 
 
 
 
 
 
 

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Budget 
Item 
Request 
Research assistant salary 
 
128,000 NTD 
Materials and Supplies 
80,000 NTD 
Printing 
12,000 NTD 
Travel 
22,000 NTD 
Consultant 
24,000 NTD 
Equipment 
34,000 NTD 
Total Costs 
300,000 NTD 
 
 
 
 
 
 

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Abstract： 
1. Chinese Abstract 
實證報告已指出智能寵物(Paro)可提供刺激以減少負面情緒並改善失智老年人的
焦慮和生活品質。然而，在現有的研究報告亦指出智能寵物對於失智老年之成效
呈現不一致的結果。先前研究亦發現智能寵物與人之間的不同的情感依附對老年
人產生不同之心理健康的影響。然而此結論仍缺乏實證研究支持。在生物因子方
面，催產素與依附，安全感，信賴等特質有相關，與多巴胺的交互作用在過去本
團隊研究中也證實與焦慮特質相關。而焦慮等相關特質，也可透過心律變異性
(HRV)的變化得知。但此生物特性在失智長輩使用智能寵物後是否有變化仍未知。
故該整合型計畫將進行三個子計畫檢視Paro 介入對特定依戀失智患者在生物醫
學、認知及心理健康之改變。 
子計畫一將採用隨機對照試驗檢視Paro介入對特定依戀失智患者之催產素，
多巴胺及自主神經之變化。採前驅隨機對照、單盲、2組平行研究、及重複測量
設計來檢視特定依戀失智老年人在智能寵物陪伴前、中、後之神經生理變化。120
名65歲以上居住在長照機構的長者將邀請作為樣本長者將被隨機分派到2個組別，
即實驗組或對照組，每組各60名。在介入前和第6周測量催產素。並在介入前、
介入第3周、第6周，及介入結束後1個月進行多巴胺檢測(finger tapping test，FTT)
以及心律變異檢測。子計畫二採混合質、量性研究設計，將針對60名實驗組的長
者為研究對象，探討特定依附型的失智長者其參與Paro 團體介入歷程、及其與
心理健康改變的相關性。將六次、30分鐘之智能寵物團體介入於長者的互動過程
進行錄影、現場摘記、轉為逐字稿後進行主題分析，並在第1、3及6次團體結束
後評量其團體氣氛與滿意度，並與子計畫三在介入前、介入後的憂鬱和孤獨感之
改變量進行相關性分析。子計畫三，長者在介入前、介入後第3周、第6周、和介
入結束後1個月進行認知功能、認知執行功能、憂鬱，孤獨感和幸福感的測量。
在介入前先使用依附類型量表（RAAS-C）對長者之依附類型進行分類，在介入
後將進行次團體分析，進一步了解不同依附類型長者在接受Paro 介入後身心健
康之變化。該研究結果將成為使用智能寵物介入對失智老年人在神經生理變化、
認知、執行功能和心理健康提供實徵證據，作為失智症照護醫療之強力證據，未
來可推廣於長期照護的模式中。 
2. Abstract  
Social robots have been validated as a therapeutic modality to provide stimuli to reduce 
the negative emotions and to improve the quality of life for people with dementia. 

4 
 
However, existing research pointed out that the effectiveness of social robot (Paro) on 
people with dementia has shown inconsistent results. Previous studies have also found 
that different emotional attachments between human and Paro have shown different 
psychological effects for older adults. However, these conclusions still lack empirical 
research support. Therefore, the integrated project will conduct three sub-projects to 
examine the changes in biomedical, cognitive, and mental health of specific attachment 
older adults with dementia after receiving group-based Paro intervention. Study 1 will 
use a pilot randomized controlled trial to examine the effect of Paro intervention on 
oxytocin, dopamine and HRV variations for specific attachment older adults with 
dementia. A randomized controlled trail, single-blind, two parallel groups, and repeated 
measures design were used to examine the effects of Paro intervention on 
neurobiologically changes for specific attachment older adults with dementia at before, 
during and after the intervention. A sample of 120 older adults with dementia who are 
65 years or older living in long-term care will be invited. Older adults will be randomly 
assigned to two groups: experimental group or control group. The outcomes will be 
assessed based on the change of dopamine and HRV at baseline, 3rd week during the 
Paro intervention, the end of intervention (6th week), and the 1 month after the Paro 
intervention. Furthermore, the change of oxytocin will be assessed at two time points: 
baseline and the end of Paro intervention. Study 2 will focus on the 60 participants of 
the 2 experimental groups. A mixed method combined qualitative and quantitative 
research design will be used to explore the participating experience, group interaction, 
and its’ association with mental health. Based on study 1 design, the outcomes of study 
3 will be assessed based on the change of cognitive, executive functions, loneliness, 
depression, and well-being at the same points of study 1.  
In addition, the Revised Adult Attachment Scale Chinese version (RAAS-C) will be 
used to classify the attachment types of the elderly. A sub-group analysis will be 
conducted to further understand the changes in the physical and mental health of the 
elderly with different attachment types after receiving Paro intervention. The results of 
this study will be used to provide empirical evidence to identify the effectiveness of 
Paro intervention on neurobiologically changes, cognition, executive functions, and 
mental well-being for the older people with dementia. These results can be promoted 
as a care model in the long-term facilities in the future. 
 

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I. 
The significant of the study 
1. 
Robot care - offering companionship and social-cognitive-functional 
support  
A prior study indicated that when older adults moved into a nursing home, there is 
a reduced likelihood that family and friends will continue to visit (Siniscarco, Love-
Williams & BurnettWolle, 2017). However, technologies such as robotics may be a 
solution to continue to offer companionship, social activities, cognitive stimulation and 
functional support to older adults who are socially isolated (Moyle et al., 2018). The 
literature showed that robotics could offer functional support and help older adults stay 
at home for longer times as they can offer services such as the monitoring and 
management of symptoms and behaviors (Moyle et al., 2017).  
Furthermore, robots can connect the older adults to family and friends for 
companionship, and they can provide cognitive stimulation through games and 
entertainment. Given the shortage of manpower, many facilities mainly provide group 
format activities rather than individualized activities to promote mental health for older 
adults. However, there is still lacking evidence to prove that whether group activities 
could improve the depression or loneliness of older adults living in long-term care 
(LTC).  
2. 
Promising psychological-social outcomes of social robots  
In recent years, there has been an increasing interest in the use of social robots to 
act as a catalyst to alleviate psychological distress and encourage social interaction for 
older adults with dementia or depression (Chen, Jones & Wendy, 2018; Moyle et al., 
2016). The evidence reviewed here seems to suggest a pertinent role of a social robot 
for older adults; however, its mechanism of human-robot has not reached the 
consistency and in-deep exploration.  
Additionally, Chu et al. (2016) revealed that engagement with robot may be an 
important indicator of human-robot affecting outcomes of intervention for elderly. 
Therefore, an innovative and empirical intervention for older adults living in LTC in 
Taiwan, is warranted.  
3. 
Social robot – PARO and its mechanism for mental health 
PARO (Personal Assistive Robot), was developed by Dr. Takanori Shibata in Japan. 
It has the appearance of a baby harp seal; the current version (V9) weighs 2.5 kilograms 

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and is approximately the size of a new-born baby. PARO is equipped with an array of 
tactile sensors that monitor sound, light, temperature and touch via artificial intelligence 
software. PARO can show human-like emotional reactions when it feels surprised, 
happy, or angry, and it will cry when it is neglected or not receiving sufficient attention.  
II. Innovation and novelty of the study 
1. Innovative theme: Neurobiology evidences of attachment, security—oxytocin, 
dopamine and HRV 
Although many studies focused on functional outcome of Paro accompany as above 
studies demonstrated, the intrinsic neurobiologically changes, with the accompany of 
Paro, is unclear. For human beings, oxytocin is a neuropeptide that originates from 
magnocellular neurons in the periventricular or supraoptic nucleus of the hypothalamus. 
Recently, evidence has demonstrated that emotion, cognitive processes and complex 
social behaviors, including discriminating subtle social cues and trusted behavior could 
be modulated by oxytocin (Kosfeld, Heinrichs et al. 2005, Domes, Heinrichs et al. 2007, 
Meyer-Lindenberg and Tost 2012). Furthermore, a dysregulated oxytocinergic system 
has also been noted in patients with social function impairments, such as autistic 
disorders (Domes, Heinrichs et al. 2013). Increasingly, literature reviews have indicated 
that oxytocin may interact with dopaminergic systems. Anatomically, oxytocin neurons 
express dopamine receptors in the hypothalamus (Baskerville, Allard et al. 2009). 
Moreover, the oxytocin fibers are close to mesolimbic dopamine cell bodies in the 
ventral tegmental areas (Melis, Melis et al. 2007). Investigation has shown that the 
dopamine and oxytocin pathways finally converge in the frontal cortex and ventral 
striatum (Meyer-Lindenberg, Domes et al. 2011). In addition, a recent study 
demonstrated dopamine D2 receptor-oxytocin receptors heteromers in the striatum, 
which might facilitate dopamine-oxytocin interaction (Romero-Fernandez, Borroto-
Escuela et al. 2012). Physiologically, the centrally projecting oxytocin neurons and 
dopaminergic systems interact to maintain cardiovascular function homeostasis and 
even modulate penile erection (Succu, Sanna et al. 2008, Pyner 2009). Behaviorally, 
dopamine neurons transmit signals related to salient social cues in addition to the 
modulation of cognitive flexibility by reward anticipation (Aarts, Roelofs et al. 2010). 
Furthermore, oxytocin has been noted to activate the mesocorticolimbic and 
nigrostriatal dopamine pathways that are involved in social and pair bond formation in 
animal studies (Liu and Wang 2003, Young and Wang 2004). Human functional 

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imaging studies revealed that ventral tegmental areas that are involved in dopamine-
mediated social reward activities and social cues processing could be activated after 
oxytocin administration (Schott, Minuzzi et al. 2008, Groppe, Gossen et al. 2013). In 
patients with schizophrenia, abnormal oxytocin-dopamine interactions in the amygdala 
have been proposed to be associated with impaired emotional salience processing with 
consequent social cognitive impairments (Rosenfeld, Lieberman et al. 2011). 
Dysfunctional dopamine-oxytocin interactions could also occur in autism (Baskerville 
and Douglas 2010) and attention deficit-hyperactivity disorder (Park, Willmott et al. 
2010). Variation in dopamine-oxytocin interplays could also contribute to individual 
differences in personality traits (Love, Enoch et al. 2012). 
Also, the above-mentioned neurobiological systems that manage stress under 
challenging environments may be clinically measurable by the autonomic nervous 
system (ANS) performance, which alters human psycho-physiological conditions 
directly in order to cope with stress (fight or flight).(Thayer, Ahs et al. 2012) For 
example, high frequency (HF) heart rate variability (HRV) predicts depressive 
symptoms in adolescents,(Vazquez, Blood et al. 2016) and reduction in HRV may lead 
to a greater risk of cardiovascular disease.(Kleiger, Miller et al. 1987) In addition, 
mentally perceived stress was found to be negatively correlated with the HF component 
of HRV.(Dishman, Nakamura et al. 2000) 
For geriatrics subjects, dopamine could be measured by finger tapping test. Our 
previous study demonstrated that FTT is correlated with dopaminergic functions(Yang, 
Chiu et al. 2003), and more studies showed that FTT could be correlated with elder 
subjects’ cognitive function(Rabinowitz and Lavner 2014).  
Paro interventions are based on human-animal interactions aimed at providing 
physiological, psychological, and social benefits. Physiological effects are triggered 
through sensory stimulation with Paro such as stroking, hugging, and kissing, and can 
result in a reduction in stress-hormone levels (Shibata et al., 2004) and lower blood 
pressure and heart rates (Robinson et al., 2015). Psychological effects are experienced 
through the comfort and joy derived during close interaction (Chang et al., 2013). Social 
benefits are provided through engagement in activities (Cohen-Mansfield et al., 2010). 
In this study, Paro will be used as a psychosocial intervention with the aim to examine 
its effect on neurobiologically variations as well as cognitive functions and group 

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process changes in specific attachment older adults with dementia. We hypothesized 
the above biomarkers demonstrated in previous studies which would be correlated to 
cognitive functions, trust and stress relieving, would also present in geriatric dementia 
patients.  
2. Innovative design: A rigorous design to build an evidence-based randomized 
controlled study to fill the gap of knowledge on Paro intervention for older 
adults with dementia. 
Much of the outcome research with social robots has been conducted in Japan and 
western countries (Moyle et al., 2017; Robinson, Broadbent, & MacDonald, 2016), 
but less rigorous research, such as RCT, has been conducted in Taiwan. So far, few 
studies have investigated the changes of biomarkers on Paro intervention to support 
the findings of well-being effects, which were found using paper instruments to 
investigate the outcomes of mental health such as depression, loneliness, and 
attachment. Hence, a RCT with a large sample size will enhance the level of evidence 
and overcome the weakness of the study. We are the first study to investigate the 
linkages between biomarkers and psychological effects on older adults with dementia 
after receiving Paro intervention in Taiwan.  
3. Expected Impact of Research 
This proposed study will thoroughly examine the effect of Paro intervention on 
biomarkers (such as oxytocin level, dopamine and HRV), and cognitive function, and 
mental well-being for specific attachment orientation older adults with dementia. This 
is the first study we know of to utilize a rigorous research design to examine the effect 
of Paro intervention and explore the linkages between biomarkers and psychological 
well-being for older people with dementia. The findings of this study will provide 
strong evidence and advance knowledge of the mechanism of Paro intervention in LTC 
of Taiwan and be able to link this result to international studies. The findings of the 
research will publish in international journals. 
III. 
Background 
Serious issues in the mental health of older populations have shown in LTC facilities 
worldwide. In Taiwan, the prevalence of dementia was 7.78% in older adults. Many 
older adults with dementia were admitted into long-term care due to BPSD. However, 
older adults moved into LTC would vitiate  quality of life and mental health due to 
insufficiency of social network. These will increase loneliness. Evidence has shown 

9 
 
that there were positive correlations between depression and loneliness (Cacioppo, 
Hughes, Waite, Hawkley, & Thisted, 2006; Tiikkainen & Heikkinen, 2005). An 
empirical study has been demonstrated that loneliness is an important influence factor 
that increased depression for older adults (Chou, 2004). These issues merit to pay 
more attention to find effective strategies. Despite this, there is limited research to 
explore the mechanism of effective interventions on depression and loneliness among 
older adults living in LTC. 
Regarding the development of the human emotional relationship, the attachment 
is an important mechanism for interpersonal interaction. An individual may have a 
higher risk to suffer from depression or loneliness when she/he cannot develop a close 
attachment relationship (i.e. presenting attachment anxiety or attachment avoidance) 
(Burnette, 2008; Schiffrin, 2014; Wei, 2005). Consequently, there is a significant 
correlation between interpersonal attachment orientations and mental health. 
A social robot has been recognized as a potential new intervention for improving 
mental well-being in the older population. Empirical studies have shown that Robot- 
pet (Paro) can be an alternative as a live animal which can provide attachment 
functions such as proximity, secure base, and safe haven. An endeavor of studies in 
the two decades, promising results of social robot in improving mood, depression, 
loneliness, and quality of life have been reported (Jøranson, Pedersen, Rokstad, & 
Ihlebæk, 2015; Moyle et al., 2013; Petersen et al., 2017; Robinson et al., 2013). Social 
robots not only can alleviate mental distress of individuals, but also encourage social 
interaction for older people with psychological distress (Jøranson et al., 2015; Moyle 
et al., 2016; Roger et al., 2012).  
No study aims to investigate the linkage between biomarkers and psychological 
well-being. The results of this study will be used to provide empirical evidence to 
identify the effectiveness of Paro intervention on neurobiologically changes for the 
older people with dementia. These results can be promoted as a care model in the 
long-term facilities in the future. 
IV. 
Objective 
The ultimate objectives of the study are to establish evidence-based Paro intervention 
to investigate the the effect of Paro intervention on biomarkers and psychological well-
being for specific attachment older adults with dementia and to explore the linkages 

10 
 
between them. In this integrated study, we will expect to achieve three aims:  
Study 1 will aim to examine the effect of the Paro intervention on oxytocin, 
dopamine and HRV for attachment-specific people with dementia. Study 2 will explore 
the relationship of group process and mental health undergoing group-based Paro 
intervention on attachment-specific people with dementia. Study 3 will examine the 
effect of the Paro intervention on cognitive, executive functions and mental well-being 
for attachment-specific people with dementia 
V. 
Work frame 
This integration project is entitled “Effect of the Group-based Paro Intervention on 
Neurobiology, Cognitive Function, and Mental well-being on older adults with 
dementia”. This project includes 3 sub-study, that is, study 1 “Effect of the Paro 
intervention on cognitive function, autonomic system, reward and attachment 
alternations on dementia subjects in dayward center —focusing on prefrontal cortical 
function, dopamine, oxytocin and heart rate variability(HRV)”; study 2 ” Exploring the 
interaction experience and its’ relationship with the change of mental health undergoing 
group-based Paro intervention on attachment-specific people with dementia: Group 
process analysis” ; and study 3” Effect of the Paro intervention on cognitive, executive 
functions and mental well-being for attachment-specific people with dementia – a pilot 
randomized controlled trial”. The aim is to establish evidence-based Robot-pet 
intervention for older adults with dementia in Taiwan. 
The principal investigator (study 1 PI) of the integration project is Wei-hung 
Chang who is a Director in Department of Psychiatry, NCKU hospital, Dou-Liou and 
is an expert at psychiatric care, dementia and aged care. He is Assistant Professor in 
Department of Psychiatry, College of Medicine, National Cheng Kung University. He 
has more than 30 publications in psychiatric and geriatric fields obtained eight awards 
from Government and Association in Taiwan. 
 The PI of study 2 is Chun-O Chien, who is an advanced nurse in mental health with 
a master degree. She also received well-trained research skill to conduct this study. 
She also has many publications in Chinese and co-author paper in English. She is also 
a person in charge to connect between school and hospital, search papers, collect data 
and help analyze data. 
The PI of study 3 is Shu-Chuan Chen who is an Assistant Professor in National 
Tainan Junior College of Nursing. The PI of integration project is expert at mental 
health, community care and aged care. She is working on a social robot intervention on 

11 
 
mental health for older adults in Taiwan for 4 years. She has competence and well-
trained research skill available to conduct this integration project. She will cooperate 
and coordinate research matters between National Tainan Junior College of Nursing 
and Cheng-Kung Hospital, train research staff to conduct project, supervise progress 
the studies, as well as quality control during the implementation.  
Our research team aims to explore intervention to investigate the effect of Paro 
intervention on biomarkers and psychological well-being for specific attachment older 
adults with dementia and to explore the linkages between them.  A randomized 
controlled trail will conduct to build the strong evidence on Paro intervention for older 
adults with dementia. Figure 1 shows that the relationship and integrations among three 
studies. Study 1 is a randomized controlled trial, which aims to examine the effects of 
the Paro intervention on cognitive function, autonomic system, reward and attachment 
alternations on dementia subjects in dayward center —focusing on prefrontal cortical 
function, dopamine, oxytocin and heart rate variability (HRV)”. The findings will be 
supported our hypothesis of study 3 to demonstrate Paro intervention improving 
psychological well-being. Study 2 is a mixed method study, which aims to exploring 
the interaction experience and its’ relationship with the change of mental health 
undergoing group-based Paro intervention on attachment-specific people with dementia: 
Group process analysis. Based on the findings of Study 1 and 3, this RCT will be built 
a robust evidence to demonstrate that Paro intervention can improve cognitive functions 
and psychological well-being for older people with dementia. 
 
 
Figure 1 The relationship and integrations among three studies 
 
 
 

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VII. Integration of resource 
(1) All equipment will use in-kind in National Tainan College of nursing (NTJIN), 
National Cheng Kung University Hospital (NCKU-H), and National Cheng Kung 
University Hospital: Dou-Liou Branch.  
(2) Study 1 will conduct at NCKU-H Dou-Liou Branch, NCKU-H related facilities, and 
senior centers to collect data and conduct Paro intrvention.  
(3) NCKU will share the library to conduct systematic review and statistical software.  
(4) Study 2 will mainly conduct in NUKU-H: Dou-Liou Branch, NCKU-H related facilities, 
and senior where will provide venue, computer, projector for research team to discuss the 
progress of project. Pilot testing of RAQ-C will conduct at NCKU-H. All equipment is 
provided by NCKU-H.  
(5) Study 3 will conduct in at NCKU-H Dou-Liou Branch, NCKU-H related facilities, long-
term care and day care center at Tainan independent facilities. Research member from 
NCKU-H will recruit participants and screening the participants. PI and two Co-PI will 
collect data and conduct intervention. Paro will provide by NTIN, other equipment are 
provided by NCKU-H.  
(6) Monthly meeting will be held by research team members who will discuss progress of 
research, difficulties, and issues at NTIN or NCKU-H.  
(7) The research outcome will present, poster, or publish in conference or seminar in 
National Tainan Jonior College of Nursing and National Cheng Kung University Hospital. 
The results will publish in SCI, SSCI, or TSSCI journals.  
VIII. Work Projects 
(1) 
Contact with the long-term care facilities and design a flyer for recruitment of 
research participants. 
(2) 
Research assistants training, establishing standardized procedures of 
intervention, developing data collection steps, related knowledge of processes 
in Paro intervention. 
(3) 
For research fidelity, monitoring experimental group and control group by 
weekly check, holding regular steering meetings to maintain the quality and 
consistency of program implementation. 
(4) 
Conduct data collection by blood examination, HRV measurement and 
psychologically testing of FTT. 

13 
 
(5) 
To submit the manuscript to international conferences and health-related 
journals. 
(6) 
To submit the final report for the project. 
IX. Expected the contribution of the Research  
 This study will thoroughly examine the effect of Paro intervention on Biomarkers 
(oxytocin level, dopamine), HRV and psychological well-being for specific attachment 
orientation older adults with dementia. This is the first study we know of to utilize a 
rigorous research design to examine the effect of intervention and explore the 
relationship between different attachment orientation older people and Paro. The 
findings of this study will provide strong evidence and advance knowledge of the 
mechanism of Paro intervention in LTC of Taiwan and be able to link this result to 
international studies. The findings of the research will publish in international journals. 
X. Expected Contribution of Research to Personnel  
There are regular training and interdisciplinary meetings for all research staff to 
strengthen their research skills, as well as expand their knowledge for newly aged care 
model such as innovated technological devices and robots for older adults. The staff 
will conduct research capacity training prior to the study, including Paro intervention, 
and data analysis. Research members will recognize measurements of FTT and HRV 
and learn how to cooperate with interdisciplinary experts. These skills will help 
members to foster teamwork and interdisciplinary knowledge and expand integration 
of knowledge systems such as nursing, psychological and robotic technology. The 
above training will help members to advance capabilities to be an independent research, 
behavioral observer, and a competent analyzer. 

14 
 
Study 1:  
Effect of the Paro intervention on cognitive function, autonomic system, reward 
and attachment alternations on dementia subjects in dayward center —focusing 
on prefrontal cortical function, dopamine, oxytocin and heart rate variability 
(HRV) 
 
Abstract 
Social robots have been validated as a therapeutic modality to provide stimuli to reduce 
the negative emotions and to improve the quality of life for people with dementia. 
However, existing research pointed out that the effectiveness of social robot (Paro) on 
people with dementia has shown inconsistent results. Previous studies have also found 
that different emotional attachments between human and Paro have shown different 
psychological effects for older adults. However, these conclusions still lack empirical 
research support. Furthermore, oxytocin is well known to be correlated with human 
attachment behaviour, security and trust feeling. Also, the interaction of dopamine and 
oxytocin is correlated with anxiety features in our previous study. The anxiety 
presentation, in previous studies indicated, could be measured physiologically by heart 
rate variability (HRV). Therefore, this study will use a pilot randomized controlled trial 
to examine the effect of Paro intervention on oxytocin, dopamine and HRV variations for 
specific attachment older adults with dementia. A randomized controlled trail, single-
blind, two parallel groups, and repeated measures design were used to examine the effects 
of Paro intervention on neurobiologically changes for older adults with dementia at 
before, during and after the intervention. A sample of 120 older adults with dementia who 
are 65 years or older living in long-term care will be invited. Older adults will be 
randomly assigned to two groups: experimental group or control group. Sixty older adults 
will be recruited to each group. The outcomes will be assessed based on the change of 
dopamine, and HRV at baseline, 3rd week during the Paro intervention, the end of 
intervention (6th week), and the 1 month after the Paro intervention. Additionally, the 
change of oxytocin will be examined at two time points: baseline and the end of the Paro 
intervention. The results of this study will be used to provide empirical evidence to 
identify the effectiveness of Paro intervention on neurobiologically changes for the older 
people with dementia. These results can be promoted as a care model in the long-term 
facilities in the future. 

15 
 
 
 

16 
 
I. 
Literature review 
1. Robot care - offering companionship and social-cognitive-functional support  
A prior study indicated that when older adults moved into a nursing home, there is 
a reduced likelihood that family and friends will continue to visit (Siniscarco, Love-
Williams & BurnettWolle, 2017). However, technologies such as robotics may be a 
solution to continue to offer companionship, social activities, cognitive stimulation and 
functional support to older adults who are socially isolated (Moyle et al., 2018). The 
literature showed that robotics could offer functional support and help older adults stay 
at home for longer times as they can offer services such as the monitoring and 
management of symptoms and behaviors (Moyle et al., 2017).  
Furthermore, robots can connect the older adults to family and friends for 
companionship, and they can provide cognitive stimulation through games and 
entertainment. Given the shortage of manpower, many facilities mainly provide group 
format activities rather than individualized activities to promote mental health for older 
adults. However, there is still lacking evidence to prove that whether group activities 
could improve the depression or loneliness of older adults living in long-term care 
(LTC).  
2. Promising psychological-social outcomes of social robots  
In recent years, there has been an increasing interest in the use of social robots to 
act as a catalyst to alleviate psychological distress and encourage social interaction for 
older adults with dementia or depression (Chen, Jones & Wendy, 2018; Moyle et al., 
2016). The evidence reviewed here seems to suggest a pertinent role of a social robot 
for older adults; however, its mechanism of human-robot has not reached the 
consistency and in-deep exploration.  
Additionally, Chu et al. (2016) revealed that engagement with robot may be an 
important indicator of human-robot affecting outcomes of intervention for elderly. 
Therefore, an innovative and empirical intervention for older adults living in LTC in 
Taiwan, is warranted.  
3. Social robot – PARO and its mechanism for mental health 
PARO (Personal Assistive Robot), was developed by Dr. Takanori Shibata in Japan. 
It has the appearance of a baby harp seal; the current version (V9) weighs 2.5 kilograms 
and is approximately the size of a new-born baby. PARO is equipped with an array of 

17 
 
tactile sensors that monitor sound, light, temperature and touch via artificial intelligence 
software. PARO can show human-like emotional reactions when it feels surprised, 
happy, or angry, and it will cry when it is neglected or not receiving sufficient attention.  
4. Neurobiology evidences of attachment, security—oxytocin, dopamine and HRV 
Although many studies focused on functional outcome of Paro accompany as 
above studies demonstrated, the intrinsic neurobiologically changes, with the 
accompany of Paro, is unclear. For human beings, oxytocin is a neuropeptide that 
originates from magnocellular neurons in the periventricular or supraoptic nucleus of 
the hypothalamus. Recently, evidence has demonstrated that emotion, cognitive 
processes and complex social behaviors, including discriminating subtle social cues 
and trusted behavior could be modulated by oxytocin (Kosfeld, Heinrichs et al. 2005, 
Domes, Heinrichs et al. 2007, Meyer-Lindenberg and Tost 2012). Furthermore, a 
dysregulated oxytocinergic system has also been noted in patients with social function 
impairments, such as autistic disorders (Domes, Heinrichs et al. 2013). Increasingly, 
literature reviews have indicated that oxytocin may interact with dopaminergic 
systems. Anatomically, oxytocin neurons express dopamine receptors in the 
hypothalamus (Baskerville, Allard et al. 2009). Moreover, the oxytocin fibers are 
close to mesolimbic dopamine cell bodies in the ventral tegmental areas (Melis, Melis 
et al. 2007). Investigation has shown that the dopamine and oxytocin pathways finally 
converge in the frontal cortex and ventral striatum (Meyer-Lindenberg, Domes et al. 
2011). In addition, a recent study demonstrated dopamine D2 receptor-oxytocin 
receptors heteromers in the striatum, which might facilitate dopamine-oxytocin 
interaction (Romero-Fernandez, Borroto-Escuela et al. 2012). Physiologically, the 
centrally projecting oxytocin neurons and dopaminergic systems interact to maintain 
cardiovascular function homeostasis and even modulate penile erection (Succu, Sanna 
et al. 2008, Pyner 2009). Behaviorally, dopamine neurons transmit signals related to 
salient social cues in addition to the modulation of cognitive flexibility by reward 
anticipation (Aarts, Roelofs et al. 2010). Furthermore, oxytocin has been noted to 
activate the mesocorticolimbic and nigrostriatal dopamine pathways that are involved 
in social and pair bond formation in animal studies (Liu and Wang 2003, Young and 
Wang 2004). Human functional imaging studies revealed that ventral tegmental areas 
that are involved in dopamine-mediated social reward activities and social cues 
processing could be activated after oxytocin administration (Schott, Minuzzi et al. 

18 
 
2008, Groppe, Gossen et al. 2013). In patients with schizophrenia, abnormal oxytocin-
dopamine interactions in the amygdala have been proposed to be associated with 
impaired emotional salience processing with consequent social cognitive impairments 
(Rosenfeld, Lieberman et al. 2011). Dysfunctional dopamine-oxytocin interactions 
could also occur in autism (Baskerville and Douglas 2010) and attention deficit-
hyperactivity disorder (Park, Willmott et al. 2010). Variation in dopamine-oxytocin 
interplays could also contribute to individual differences in personality traits (Love, 
Enoch et al. 2012). 
 the above-mentioned neurobiological systems that manage stress under 
challenging environments may be clinically measurable by the autonomic nervous 
system (ANS) performance, which alters human psycho-physiological conditions 
directly in order to cope with stress (fight or flight).(Thayer, Ahs et al. 2012) For 
example, high frequency (HF) heart rate variability (HRV) predicts depressive 
symptoms in adolescents,(Vazquez, Blood et al. 2016) and reduction in HRV may lead 
to a greater risk of cardiovascular disease.(Kleiger, Miller et al. 1987) In addition, 
mentally perceived stress was found to be negatively correlated with the HF 
component of HRV.(Dishman, Nakamura et al. 2000) 
For geriatrics subjects, dopamine could be measured by finger tapping test. Our 
previous study demonstrated that FTT is correlated with dopaminergic functions(Yang, 
Chiu et al. 2003), and more studies showed that FTT could be correlated with elder 
subjects’ cognitive function(Rabinowitz and Lavner 2014).  
Paro interventions are based on human-animal interactions aimed at providing 
physiological, psychological, and social benefits. Physiological effects are triggered 
through sensory stimulation with Paro such as stroking, hugging, and kissing, and can 
result in a reduction in stress-hormone levels (Shibata et al., 2004) and lower blood 
pressure and heart rates (Robinson et al., 2015). Psychological effects are experienced 
through the comfort and joy derived during close interaction (Chang et al., 2013). Social 
benefits are provided through engagement in activities (Cohen-Mansfield et al., 2010). 
In this study, Paro will be used as a psychosocial intervention with the aim to examine 
its effect on neurobiologically variations as well as cognitive functions and group 
process changes in specific attachment older adults with dementia. We hypothesized 
the above biomarkers demonstrated in previous studies which would be correlated to 
cognitive functions, trust and stress relieving, would also present in geriatric dementia 

19 
 
patients.  
II. Method 
1. 
Aims  
The aims of this study is to examine the effect of the Paro intervention on oxytocin, 
dopamine and HRV for attachment-specific people with dementia. 
2. 
Objectives  
(1) To examine the effect of Paro intervention on oxytocin level for the older people 
with dementia. 
(2) To examine the effect of Paro intervention on dopaminergic activities in terms 
of FTT for older people with dementia. 
(3) To examine the effect of Paro intervention on HRV changes, naming autonomic 
functions for older people with dementia. 
(4) To examine the effect of Paro intervention on the associations of the above 
neurobiologically variations and cognitive functions 
(5) To examine the effect of Paro intervention on the associations of the above 
neurobiologically variations and group process 
 
3. 
Research design 
This is a repeated measures study that is a pilot randomized controlled trail, four 
parallel groups, and double-blind design. It is used to examine the effects of Paro 
intervention on cognition, executive functions, and mental well-being for specific 
attachment older adults with dementia at before, during and after the intervention. A 
mixed between-within subjects analysis of variance design will be used to assess the 
immediate effects of the 6-week Paro intervention on cognitive, executive and three 
mental well-being related variables for different attachment orientations of older adults 
living LTC facilities. Outcomes of interest measures will include dopaminergic 
activities variations by FTT and HRV changes at three time points: before the 
intervention (T0), middle of intervention (week-3, T1), the end of intervention (week-
6, T2), and 1 month after the intervention (T2). Furthermore, the change of oxytocin 
level will be assessed at baseline and the end of the intervention. 
The purpose of this study is to examine the effect of Paro intervention on 
neurobiologically changes for older adults with dementia in LTC. The research design 
is shown in Table1.  

20 
 
Table 1 Research design for Paro intervention 
Group 
Subgroup 
T0 
Intervention 
T1 
T2 
T3 
Security  
Experiment 
O1 
X 
O2 
O3 
O4 
Control 
O1 
 
O2 
O3 
O4 
Experiment group: Paro intervention; Control group; O1: Baseline; O2: Week 3; O3: Week 6; 
O4: Week 10 
4. 
Sample size, Sampling, Settings, and Participants Recruitment  
There are 120 participants will be recruited into this pilot randomized controlled 
trial from LTC facilities in southern Taiwan. Older adults will be randomly assigned to 
four groups: experimental group or control group. The purpose of sampling will be used 
to allocate 60 participants either to the experimental group or the control group using 
computer generated sampling. Contact has been made with the Directors of the LTC 
facilities who have expressed their interest in being involved in the study. Directors will 
invite older adults who meet the inclusion criteria to participate in this study.  
The inclusion criteria of elderly participants will be: (1) aged 65 years or over; (2) 
Mild to moderator dementia (3) an ability to communicate in Mandarin or Taiwanese; 
and (4) has been living in the LTC facility at least 3 months. Older adults who: (1) have 
severe difficulty in communication; (2) are totally dependent on carers for daily activity; 
(3) have a diagnosed infectious disease, severe dementia, and severe mental illness such 
as schizophrenia and delusional disorder, will be excluded from the study. 
5. 
Intervention 
Participants in the experimental group will receive a group (6-8 people as a group) , 
facilitated, and 30-minute weekly session Paro intervention for 6 weeks. The control 
group will receive care as usual activities, such as painting, drawing, and craft, which 
are provided by each facility. 
6. 
Paro 
Paro (Personal Assistive Robot), was developed by Dr Takanori Shibata in Japan. 
It has the appearance of a baby harp seal; the current version (V9) weighs 2.5 kilograms 
and is approximately the size of a new-born baby. Paro is equipped with an array of 
tactile sensors that monitor sound, light, temperature and touch via artificial intelligence 
software. Paro can show human-like emotional reactions when it feels surprised, happy, 
or angry, and it will cry when it is neglected or not receiving sufficient attention.  

21 
 
In this study, Paro will be used as a Robot-pet companionship intervention with 
the aim to improve mental health in terms of different attachment orientations. Robot-
pet companionship interventions are based on human-animal interactions aimed at 
providing physiological, psychological, and social benefits (Robinson et al., 2015; 
Chang et al., 2013; Cohen-Mansfield et al., 2010; Shibata et al., 2004). 
   
Figure 1. The images of Paro 
 
7. 
Procedure of interaction records 
Participants in experimental groups will receive a group, facilitated, 30-minute 
weekly session of Paro intervention. A trained research assistant (RA) give the Paro to 
the participants at the start of each session, repeating the same introductory script each 
time. The RA facilitate the participant interact with the Paro during the intervention, 
after 30 minutes RA will use the same ending script to end the session and goodbye to 
participants.  
 
8. 
Outcome measures 
The process and outcome of measurement will be blinded and assessed by another 
RA at four time points: baseline (T0), Week 3(T1), Week 6 (T2), and 1 month after the 
end of intervention(T3). The primary outcomes are oxytocin level, FTT results and 
HRV tests.  
Table 2 Measurement time points and measurements 
Instrument 
Week-0 
(T0) 
Week-3 
(T1) 
Week-6 
(T2) 
Follow-
up 
(T3) 
Demographics/disease 
 
 
 
 

22 
 
information 
Outcome measure 
 
 
 
 
-oxytocin level 
 
 
 
 
-FTT 
 
 
 
 
-HRV 
 
 
 
 
Note. , collect data; FTT: finger tapping test HRV: heart rate variabiility 
(1) Demographic data 
Participants’ demographics such as age, gender, education level, religion, number 
of children, and previous pet ownership will be collected. Disease-related information 
will include the length of stay in the LTC, type of depressive disorder, any other chronic 
disease, a medication audit including antidepressants and other medications, and 
Barthel index of Activities of Daily Living. 
(2) Oxytocin measurement 
Blood samples for the oxytocin assay were collected from the antecubital vein into 
pre-chilled 5 ml EDTA tubes with 250 KIU of apoprotinin, and refrigerated until 
processing. Plasma was isolated by centrifugation at 1800 × g for 15 minutes at 4°C and 
stored in aliquots at −70°C. The oxytocin immunoreactivity level was quantified in 
duplicate using a commercial oxytocin ELISA kit (Enzo Life Sciences, NY, USA, 
formerly Assays Designs, MI, USA). 
 
(3) Finger tapping test  
The FTT consists of tapping with the index finger on a computer mouse as many 
times as possible within 10 s. The test was repeated three consecutive times and 
performed randomly across subjects, and the order was kept constant in each subject at 
each session. The average number of taps was then calculated 
(4) HRV measurements 
ANS activity. A full 20-minute period of recumbent acclimatization in a quiet 
room that was maintained at a comfortable temperature (25–27°C) preceded the 
cardiovascular measurements, which started at 10 AM. Subjects were asked to relax 
and breathe normally to avoid hyperventilation. Cardiac autonomic function was 

23 
 
calculated by the geometric method, which is based on short-term measurements of the 
interbeat interval (IBI).(Toichi, Sugiura et al. 1997) Briefly, the sequence of IBI (IBI1, 
IBI2, …, IBIn) was transformed into a figure on a two-dimensional plane by plotting 
IBIk+1 against IBIk. The length of the transverse axis (T) is affected by both the 
sympathetic and parasympathetic blockades, whereas the length of the longitudinal axis 
(L) is affected only by the parasympathetic blockade. Thus, log10 (L × T) is a cardiac 
vagal index, whereas the L/T ratio is a cardiac sympathetic index. These two indices 
have been demonstrated to be more reliable than conventional measures including 
spectral analysis.(Toichi, Sugiura et al. 1997) This geometric method has been found 
to be a sound measurement,(Kamen, Krum et al. 1996) and its advantages include: (i) 
controlled respiration or other maneuvers are not required, and (ii) as few as 100 IBIs 
are sufficient for the assessment.(Toichi, Sugiura et al. 1997) 
Power spectral density analysis of HRV was performed by fast Fourier 
transformation.(Task force of the European society of cardiology and the North 
American society of pacing and electrophysiology 1996) Several spectral components 
were defined as follows: low frequency (LF) (0.04 to 0.15 Hz), HF (0.15 to 0.40 Hz), 
and total power (≤ 0.4Hz). The very low frequency (VLF) data were excluded, because 
the available VLF data in short-term recording is dubious and should be avoided.(Task 
Force of the European Society of Cardiology the North American Society of Pacing 
1996) The total power represents the total autonomic activity. The HF power of HRV 
represents an index of cardiac parasympathetic (vagal) activity, whereas the LF power 
represents an index of vasomotor sympathetic activity, or both sympathetic and vagal 
activities. The LF/HF ratio has been proposed as an index of the relative balance of 
sympatho-vagal influences on the heart, with higher LH/HF ratios reflecting increased 
sympathetic activity or decreased parasympathetic modulation.(Malliani, Lombardi et 
al. 1990) These indexes were ln-transformed to correct the skewness. 
Autonomic function during resting. The beat-to-beat blood pressure (BP) of the 
left radial artery and the heart rate were monitored for 5 minutes while subjects 
remained in the supine position. BP and heart rate were continuously monitored using 
a Tonometry BP Monitor (Colin BP-508, Colin Co., Komaki-City, Aichi, Japan) and 
input into a computer console. The referential BP was recorded using a 
sphygmomanometer cuff over the right brachial artery and measured at intervals of 2.5 
minutes. Whenever the tonometry BP measurement was questionable or failed, cuff 
measurement for calibration was automatically started. 

24 
 
Autonomic function during the respiratory challenge test. The subjects were 
asked to take a deep breath and the heart rate was continuously recorded. Each deep 
breath cycle contained a five-second inspiration and a five-second expiration; 5 
successive breath cycles were measured in one assessment. We subtracted the minimum 
HR during expiration from the maximum HR during inspiration for each cycle of 
breathing, the time interval between two cycles being one minute, and then determined 
the mean of the differences. The differences were recorded as the mean heart rate range 
(MHRR), which is one of the most widely-used methods by which to assess HRV under 
respiratory challenge testing.(Shields 2009) 
III. Expectation Outcome 
We expect to identify positive effect of Paro intervention on neurobiologically 
changes for older adults with dementia. 
IV. Ethical Considerations 
Ethics approval for both phases of the study will be sought from Cheng-Kung 
University Human Research Ethics Committee and prior to the commencement of the 
study. Ethics approval for the study will also be sought from the participating LTC 
facilities in Taiwan prior to the commencement of the study. The researcher will inform 
the participants about the aims and objectives of the research study and what their 
participation will involve. Participants will be assured that (a) their participation will 
be on a voluntary basis and they are under no obligation to participate; and (b) they are 
free to withdraw from the study at any time without explanation, penalty or 
compromising their relationship with the LTC. A signed consent form will be sought 
from each participant. There are no foreseeable risks associated with participation in 
the intervention for participants. 
All collected data will be stored electronically with password-protection to prevent 
unauthorised access to the data. All data and related documents will be kept in a key-
locked cabinet for 5 years before being destroyed. Although demographic data will be 
requested, participants will remain anonymous. For quantitative data, all data will be 
de-identified at data entry and results will be reported in general terms. For qualitative 
data, the digital interview files will be deleted after transcription. Data will be de-
identified with codes and content separated. Anonymity will be maintained via 
pseudonyms for direct interview quotes used in the reporting of findings.  

25 
 
For ethical consideration, our research team will provide opportunity for the 
elderly in the control group who receiving plush toy. They can choose to partake two 
50-minute sessions of group-based Paro interventions to experience interactions with 
Paro after completing their intervention and follow up. 
V. Expected difficulties encountered and solutions 
1. 
Difficulties for participant’s recruitment and active engagement data 
collection 
This study will conduct 6 weekly sessions of Paro intervention in LTC facilities. 
Older adults may feel anxious about interaction with a Paro or withdraw from the 
intervention. For dealing with this potential problem, the possible solutions are as below: 
(1) The research team will hold a briefing to explain the research process to the 
participating institutions in order to attract the participation of the heads of the 
institutions. 
(2) Introducing the Paro to family and encourage family and workers interacting 
with the Paro. Also, encouraging participants share their experiences with 
his/her friends.  
(3) Provide incentives or motives for participants and explaining the research 
procedure and potential benefits for them. The research team will show a Paro 
video or demonstrate Paro interaction to participants and facilities to introduce 
how the Paro interact with other older adults and share with experiences to using 
it.  
2. 
Difficulties in quality assurance and quality control in Paro research 
As a limited number of Paro, each round will plan to recruit 6 participants. The 
research team will extend the study periods to recruit enough participants. For 
controlling the research quality, the possible solutions are as below: 
(1) To increase the quality and consistency of interaction with Paro. Each facility 
will recruit two volunteering care staff to participate in the study. Staff will 
receive 1 hour of Paro interactive training. Each care staff will provide 
incentives and motives to increase motivation to partake this study. 
(2) For reducing the interference or contamination among the four groups. This 
study will recruit control group and experimental groups in different levels to 
prevent interference among groups receiving intervention at the same time in 

26 
 
the same facility. 
(3) To reduce the human interferences. In order to establish a research consensus 
among institutional staff, we will provide a 60-minute course to workers in 
participating facilities, the purpose of which is to help them to familiarize 
with our programs and procedures  
 
VI. Expected the contribution of the Research  
This study will thoroughly examine the effect of Paro intervention on oxytocin 
level, dopamine and HRV for specific attachment orientation older adults with dementia. 
This is the first study we know of to utilize a rigorous research design to examine the 
effect of intervention and explore the relationship between different attachment 
orientation older people and Paro. The findings of this study will provide strong 
evidence and advance knowledge of the mechanism of Paro intervention in LTC of 
Taiwan and be able to link this result to international studies. The findings of the 
research will publish in international journals. 
VII. Expected Contribution of Research to Personnel  
There are regular training and interdisciplinary meetings for all research staff to 
strengthen their research skills, as well as expand their knowledge for newly aged care 
model such as innovated technological devices and robots for older adults. The staff 
will conduct research capacity training prior to the study, including Paro intervention, 
and data analysis. Research members will recognize measurements of FTT and HRV 
and learn how to cooperate with interdisciplinary experts. These skills will help 
members to foster teamwork and interdisciplinary knowledge and expand integration 
of knowledge systems such as nursing, psychological and robotic technology. The 
above training will help members to advance capabilities to be an independent research, 
behavioral observer, and a competent analyzer. 
 
 
 
 

27 
 
Study 2:  
To explore the interaction experience and its’ relationship with the change of 
mental health undergoing group-based Paro intervention on people with dementia: 
Group process analysis 
Abstract 
Social robots have been validated as a therapeutic modality to provide stimuli to 
reduce the negative emotions and to improve the mental health for people with dementia. 
Different psychological effects for older adults those who had different emotional 
attachments styles between human and Paro had been found. However, these 
conclusions still lack empirical evidence and consistent results about the effectiveness 
of group-based social robot (Paro) on people with dementia. 
Therefore, this integrated study will use a randomized controlled trial (RCT) to 
examine the process and outcomes of a weekly 6-session group-based Paro intervention. 
The association of group process and mental health for specific attachment older adults 
with dementia will be validated. A RCT, single-blind, four parallel groups, and repeated 
measures design were used to examine the effects of Paro intervention at before and 
after the intervention. Sixty older adults will be randomly assigned to two groups: 
experimental group or control group. In the subproject 2, we particularly focus on the 
60 participants of the experimental group with dementia who are 65 years or older 
living in long-term care. A mixed method combined qualitative and quantitative 
research design will be used to explore the participating experience, group interaction, 
and its’ association with mental health. 
Thematic analysis will be conducted by the video-recorded, group process, memo 
and verbatim of 6 weekly 30-minute session Paro intervention after obtaining the 
inform consent of the participants. The group climate and satisfaction will be assessed 
at the end of 1st, 3rd, 6th session by group observers, and participants, respectively. The 
corelation will be examined between the group process with the change of loneliness 
and depression at pre- and post- intervention that conducted by subproject 3. We expect 
to assure and contrast the process and group effectiveness in this subproject. The study 
findings will provide empirical result to utilize the group-based Paro intervention for 
the older people with dementia. A strong evidence will be established to promote the 
alternative therapy into different attachment styles of dementia care, combining the 

28 
 
artificial-intelligence product as a care model in the long-term facilities in the future. 
 
 

29 
 
I. Literature Review 
1.Robot care - offering companionship and social-cognitive-functional support       
Older adults living in Long Term Care(LTC) may alienate their social connections. 
When older adults moved into a nursing home, there is a reduced likelihood that family 
and friends will continue to visit (Siniscarco, Love-Williams & BurnettWolle, 2017). 
Therefore, even older adults adapt to their new living environment, often the feeling of 
loneliness and isolation does not abate over time as they find it difficult to form new 
relationships with the surrounding people (Robinson et al., 2013). Past studies have 
found that there is a positive correlation between depression and loneliness. Older 
adults with high levels of loneliness tend to experience higher levels of depression and 
more negative emotions (Chen et al., 2020; Mendes, 2015)。 
However, technologies such as robotics may be a solution to continue to offer 
companionship, social activities, cognitive stimulation and functional support to older 
adults who are socially isolated (Moyle et al., 2018). Social robots have much positive 
help to the elderly, in long-term care institutions, social animal robots can become social 
"ice breakers", providing companionship, meaning and comfort. Through interaction 
with animals to enhance social interaction, reduce depression and loneliness, and 
improve the standard of quality of life(Chen et al., 2020; Hung et al., 2019; 胡慧芳 et 
al., 2014). 
In addition, robots can connect the accompany of the elderly with family and 
friends, and they can provide cognitive stimulation through games and entertainment. 
The most common social robot, Paro, enables people to have an emotional attachment 
to the robot through interaction with the robot. (Chen et al., 2020)。 
Furthermore, robots can connect the older adults to family and friends for 
companionship, and they can provide cognitive stimulation through games and 
entertainment. Given the shortage of manpower, many facilities mainly provide group 
format activities rather than individualized activities to promote mental health for older 
adults. However, there is still lacking evidence to prove that whether group activities 
could improve the depression or loneliness of older adults living in long-term care 
(LTC).  
2.Promising psychological-social outcomes of social robots  

30 
 
In recent years, there has been an increasing interest in the use of social robots to 
act as a catalyst to alleviate psychological distress and encourage social interaction for 
older adults with dementia or depression (Chen, Jones & Wendy, 2018; Moyle et al., 
2016). The evidence reviewed here seems to suggest a pertinent role of a social robot 
for older adults; however, its mechanism of human-robot has not reached the 
consistency and in-deep exploration.  
Additionally, Chu et al. (2016) revealed that engagement with robot may be an 
important indicator of human-robot affecting outcomes of intervention for elderly. 
Therefore, an innovative and empirical intervention for older adults living in LTC in 
Taiwan, is warranted.  
3.Group-based PARO intervention and its mechanism for mental health 
PARO (Personal Assistive Robot), was developed by Dr. Takanori Shibata in Japan. 
It has the appearance of a baby harp seal; the current version (V9) weighs 2.5 kilograms 
and is approximately the size of a new-born baby. PARO is equipped with an array of 
tactile sensors that monitor sound, light, temperature and touch via artificial intelligence 
software. PARO can show human-like emotional reactions when it feels surprised, 
happy, or angry, and it will cry when it is neglected or not receiving sufficient attention.  
Group activities provide a promising venue to address social needs as well as the 
need for meaningful engagement for persons with dementia within a limited fiscal 
framework. The presentation of a theoretical framework for such group activities and 
the validation of an assessment of engagement during group activities provide a first 
step in examining the parameters affecting group processes in this population(Cohen-
Mansfield et al., 2017). 
Paro interventions are based on human-animal interactions aimed at providing 
physiological, psychological, and social benefits. Physiological effects are triggered 
through sensory stimulation with Paro such as stroking, hugging, and kissing, and can 
result in a reduction in stress-hormone levels (Shibata et al., 2004) and lower blood 
pressure and heart rates (Robinson et al., 2015). Psychological effects are experienced 
through the comfort and joy derived during close interaction (Chang et al., 2013). In 
the study of Wan-Ling Chang and Selma Španović (2013), it was found that within the 
progress of Paro group activities, the more it can cause patients with dementia to be 
more willing to actively interact with Paro, and it can promote patients' motivation 

31 
 
physical activity(Chang et al., 2013). Although many studies have pointed out the 
positive impact of Paro intervention on patients with dementia on the physical, 
psychological and social interaction levels, there is no research focusing on the impact 
of group-based Paro intervention on patients with dementia.。Social benefits are 
provided through engagement in activities (Cohen-Mansfield et al., 2010). In this study, 
Paro will be used as a psychosocial intervention with the aim to examine its effect on 
cognitive, executive, depression, loneliness, and mental well-being in specific 
attachment older adults with dementia.  
Group robotic pet-assisted therapy has been proven to improve the mood and 
behavior of the elderly with dementia. Chen et al. (2020) search nine electronic 
databases（ [CINAHL], MEDLINE, PsycINFO, PubMed, Web of Science, Scopus, 
Cochrane Library, Embase and Proquest）for related research, the search terms used 
were older adults, social robot, and depression。The search aimed to identify published 
and full-text articles from January 2000 to April 2017, a total of 7 articles was included, 
including 6 RCTs and 1 systematic literature review. Five studies contained people with 
dementia, and two recruited people from LTC facilities。The social robot interventions 
with each session lasting from 10 mins to 60 mins，The number of interventions is 
twice a week and the duration is 5-12 weeks. The results of the study confirm that the 
group intervention of Paro can improve the depression and restlessness of the elderly 
with dementia (Chen, 2018 ). 
Hu et al. (2014) Use social robot (Paro) for group robot-assisted therapy of elderly 
people with dementia, a total of 12 elderly people with dementia. The leaders guided 
the elderly with dementia to interact with robot seals in language and body, 2 times a 
week, 40 minutes each time, for 4 weeks. It was found that the elderly with dementia 
had depression and agitated behaviors after receiving group robot pet-assisted treatment 
All have significant meaning. 
Hu et al. (2012) used group robot-assisted therapy, adopts 8-10 person in one group 
and uses Paro as auxiliary device to integrate into the care process, twice a week, 30 
minutes each time, a total of 8 times, guiding face-to-face dialogue with pets, petting 
interactive. Analyzing the behavior of an elderly with dementia in the group process, it 
was found that the case had less interaction and vituperate and other negative behaviors 
at the beginning of the group. Until the third time the group began to show positive 
behaviors, actively greeted and greeted and praised the pet. After attending group robot-
assisted therapy, this case had reduction on his day-time drowsiness, night-time sleep 

32 
 
interruption, and occurrence of behavioral and psychological symptoms. The elder also 
had improvement on his cognitive function, orientation, emotion, and social interaction.  
Jøranson et al. (2015) randomly assigned for group robotic pet-assisted therapy in 
Ten adapted units in nursing homes. A total of 53 elderly people with dementia (27 in 
the Intervention group; 26 in the control group), twice a week, 30 minutes each for 12 
weeks, the study found the signiﬁcant effect on depression and agitation by using Paro 
in activity groups for elderly with dementia in nursing homes. However, in the study of 
Jøranson et al. (2016), it was found that the group robot pet-assisted treatment had less 
significant improvement effect on the quality of life.  
The literature of Abrams (2020) pointed out that observing the interaction of robot 
care mode and the human interaction group, it is necessary to explore the group 
dynamics generated during the group process and the individual feelings of group 
members, including ingroup Identiﬁcation, Cohesion and Entitativity. The process 
needs to examine whether everyone can enter the group goal to generate group cohesion, 
so that the group can generate positive and negative experiences due to the intervention 
of robot care, and whether members are satisfied with the tasks assigned in the group. 
Most studies have explored the effects of robotic pet-assisted treatment based on 
the emotions, symptoms and behaviors of elderly people with dementia, but there is no 
research related to robotic pet-assisted therapy that explores the correlation between 
personality traits and group history. The study will design from the perspective of the 
elderly with dementia to analyze the group journey accompanied by robot pets. 
II. Method 
1. Aims  
The aim of this study is to explore the relationship of group process and mental 
health undergoing group-based Paro intervention on attachment-specific people with 
dementia 
2. Objectives  
(1)  To explore the positive and negative interaction experience of the 6-session 
group-based Paro intevention process from the viewpoints of participants.  
(2) To examine the change and differience of group climate in the Paro intervention 
process from the viewpoints of group observers by groups. 
(3) To examine the change and differience of group satisfaction in the Paro 

33 
 
intervention process from the viewpoints of group participants by groups.  
(4) To exmine the relationship between changes of group process and group 
outcomes (loneliness and depression) by groups.  
 
Figure 1. The conceptual framework of group process and mental health undergoing 
group-based Paro intervention  
 
3.  Research design 
This is a mixed method study that combined a qualitative and quasi-experimental 
design with two parallel groups. In the experimental groups, content analysis will be 
used to explore the group interaction experience with vedio-recorded and transcribe 
verbatim. A between-within subjects analysis of variance design will be used to assess 
the 6-session Paro intervention on the group process variables which include group 
climate and group satisfaction. Relationship between changes of group process and 
mental health by groups will be examined with a correlation analysis. Outcomes of 
interest measures will include group process at three time points: the first, third, and 
sixth session intervention; and mental health will be measured before the intervention 
and (T0) the end of intervention (6-session, T1). 
The purpose of this study is to explore the relationship of group process and mental 
health undergoing group-based Paro intervention on older adults with dementia in LTC. 
The research design is shown in Table1.  
 
 
 
 
 
 

34 
 
Table 1 Research design for exploring the group process and outcomes of group-
based Paro intervention 
Group 
T0 
Intervention /  
Group process 
T1 
Experiment 
group 
O1 
X (1st, 3rd , 6th session) 
O2 
Note: T0 (before the intervention); T1 (after 6th session intervention); X (the group-based Paro 
intervention will be video-record, the group process will be analyzed by content analysis, and 
the group climate and satisfaction at session 1st, 3rd , and 6th will be assessed); O1, O2: Outcomes 
of measurement include the loneliness and depression assessment.  
5. Sample size, Sampling, Settings, and Participants Recruitment 
In the subproject 2, will focus on the participants in the experimental group (n=60). 
Contact has been made with the Directors of the LTC facilities who have expressed 
their interest in being involved in the study. Directors will invite older adults who meet 
the inclusion criteria to participate in this study.  
The inclusion and exclusion criteria of elderly participants will be the same study 1. 
6. 
Intervention 
The Paro intervention will be the same study 1. 
7. 
Outcome measures  
Each group interaction experience will be video-recorded and measured. The 
group process will be assessed at the first, third and sixth intervention. The group 
outcomes of mental health will be assessed at two time points: before the intervention 
(baseline, T0) and after the final session(T1). The primary outcome is group experience 
which will be transcribed verbatim and assessed with a content analysis. Group climate 
and satisfaction will be analyzed as the group process. Loneliness and depression will 
be assessed and the relationship of the change between mental health and group process 
will be examined.  
 
 
 

35 
 
Table 2 Measurement time points and measurements 
Instrument 
Baseline 
(T0) 
Intervention 
6th 
Session 
(T1) 
Demographics/disease 
information 
 
 
 
Group process measure 
 
 
 
-Experience of group 
participants 
 
 
(each 
session) 
 
 -Group climate 
 
(1st, 3rd, 6th 
session) 
 
 -Group satisfaction 
 
(1st, 3rd, 6th 
session) 
 
Outcome measure 
 
 
 
-Loneliness (UCLA) 
 
 
 
-Depression (GDS-SF) 
 
 
 
 
8. 
Data analysis 
(1) Qualitative data analysis 
Qualitative data analysis was guided by the method of thematic analysis (Braun & 
Clarke, 2006) to provide an insight into the understanding of participants’ experiences 
and perception when receiving the Paro intervention. A software N-Vivo 12.0 will be 
used to analyze the six sessions of group interaction verbatim initially. The focus of this 
study is to discover the positive and negative experience of group process from the 
participants. Chinese version of Yalom’s Therapeutic Factors (Chung et al., 2011), anti-
therapeutic factors (Lin & Wang, 1998), and therapeutic effectiveness (Lin et al., 1999) 
will be used as a coding framework. Additionally, the change of group process during 
6-session Paro intervention will be extracted into themes, subthemes and behavior units, 
such as beneficial/ hindering experience sharing, participating or interacting behaviors 
with Paro or peers and etc.  
Qualitative data analysis was guided by the method of thematic analysis (Braun 
& Clarke, 2006) to provide an insight into the understanding of participants’ 
experiences and perception when receiving the group-based Paro intervention. The 
themes and subthemes will be coded by using the following six steps: (i) 
familiarization with data; (ii) generation of initial codes; (iii) identification of themes; 
(iv) reviewing themes; (v) defining and naming themes; and (vi) producing the report. 
(2) Trustworthiness 

36 
 
The rigor of research refers to the degree of confidence in data, interpretation, and 
methods used to ensure the quality of a study (Polit & Beck, 2014). In this study, several 
strategies were used to ensure trustworthiness. First, monitoring of the rigor of the study 
was carried out by peer debriefing at regular meetings with the research team. Second, 
persistent weekly observation was used as a strategy to ensure trustworthiness during 
the data analyses (Korstjens & Moser, 2018). Third, an audit trail, which was a 
transparent description of the qualitative research steps taken from the commencement 
of the study to the development and reporting of the findings, was used to establish 
confirmability of the qualitative results. 
(3) Quantitative data analysis 
Data will be analyzed using the Statistical Package for Social Science (SPSS) for 
Windows software version 26 (IBM Corp.). Data collected will be reviewed for 
completeness and consistency within a single data form. Approximately 10% of the 
data entry will be checked for accuracy and consistency (Gad & Taulbee, 1996). Last 
observation carried forward method will be used to manage missing data at random 
(Kang, 2013). An intention-to-treat approach (Gupta, 2011) will be used in which all 
participants will be analyzed according to their enrolment.  
Descriptive statistics will be used to analyses demographic data where normality 
of data distribution for the outcome variables will be examined using probability plots 
and Kolmorgorov-Smironov tests. Frequency and percentages will be used to 
summarize categorical variables such as gender and educational level. Mean, standard 
deviation, and range will be reported to present continuous variables such as age and 
the score of all scales. Demographic characteristics and baseline data of participants 
will be compared with different subgroups, using chi-square for categorical variables 
or t-test (or Mann-Whitney U test) for continuous variables. Relationships between 
demographic characteristics and outcome measures will be explored using Pearson’s 
correlations. Cronbach’s alpha will be used to check the reliability of all instruments. 
Differences between the pre and post-test in relation to outcome measures 
(loneliness and depression) will be used a mixed between-within subjects analysis of 
variance design to assess the immediate effects of the 6-week Paro intervention on 
mental health. The association of group process variables (group climate and 
satisfaction) and mental health will be examined for different attachment orientations 
of older adults living LTC facilities. A p value < .05 will be taken as the level of 

37 
 
statistical significance. The 95% confidence interval around the differences will be 
calculated. 
III. Expectation Outcome 
We expect to explore the group process and its’ relationship with mental health 
(depression and loneliness) of 6-session group-based Paro intervention, and beneficial 
and hindering group experience of older adults with dementia. 
IV. Ethical Considerations 
Ethics approval for both phases of the study will be sought from Cheng-Kung 
University Human Research Ethics Committee and prior to the commencement of the 
study. Ethics approval for the study will also be sought from the participating LTC 
facilities in Taiwan prior to the commencement of the study. The researcher will inform 
the participants about the aims and objectives of the research study and what their 
participation will involve. Participants will be assured that (a) their participation will 
be on a voluntary basis and they are under no obligation to participate; and (b) they are 
free to withdraw from the study at any time without explanation, penalty or 
compromising their relationship with the LTC. A signed consent form will be sought 
from each participant. There are no foreseeable risks associated with participation in 
the intervention for participants. 
All collected data will be stored electronically with password-protection to prevent 
unauthorised access to the data. All data and related documents will be kept in a key-
locked cabinet for 5 years before being destroyed. Although demographic data will be 
requested, participants will remain anonymous. For quantitative data, all data will be 
de-identified at data entry and results will be reported in general terms. For qualitative 
data, the digital interview files will be deleted after transcription. Data will be de-
identified with codes and content separated. Anonymity will be maintained via 
pseudonyms for direct interview quotes used in the reporting of findings.  
For ethical consideration, our research team will provide opportunity for the 
elderly in the control group who receiving plush toy. They can choose to partake two 
50-minute sessions of group-based Paro interventions to experience interactions with 
Paro after completing their intervention and follow up. 

38 
 
V. Exected difficulties encountered and solutions 
1. 
Difficulties for participant’s recruitment and active engagement data 
collection 
This study will conduct 6 weekly sessions of Paro intervention in LTC facilities. 
Older adults may feel anxious about interaction with a Paro or withdraw from the 
intervention. For dealing with this potential problem, the possible solutions are as below: 
(4) The research team will hold a briefing to explain the research process to the 
participating institutions in order to attract the participation of the heads of the 
institutions. 
(5) Introducing the Paro to family and encourage family and workers interacting 
with the Paro. Also, encouraging participants share their experiences with 
his/her friends.  
(6) Provide incentives or motives for participants and explaining the research 
procedure and potential benefits for them. The research team will show a Paro 
video or demonstrate Paro interaction to participants and facilities to introduce 
how the Paro interact with other older adults and share with experiences to using 
it.  
2. 
Difficulties in quality assurance and quality control in Paro research 
As a limited number of Paro, each round will plan to recruit 6 participants. The 
research team will extend the study periods to recruit enough participants. For 
controlling the research quality, the possible solutions are as below: 
(1) To increase the quality and consistency of interaction with Paro. Each facility 
will recruit two volunteering care staff to participate in the study. Staff will 
receive 1 hour of Paro interactive training. Each care staff will provide 
incentives and motives to increase motivation to partake this study. 
(2) For reducing the interference or contamination among the four groups. This 
study will recruit control group and experimental groups in different levels to 
prevent interference among groups receiving intervention at the same time in 
the same facility. 
(3) To reduce the human interferences. In order to establish a research consensus 
among institutional staff, we will provide a 60-minute course to workers in 

39 
 
participating facilities, the purpose of which is to help them to familiarize 
with our programs and procedures  
3. 
Difficulties in assure the rigor in analyzing group process. 
The rigor of research will be the challenge of the qualitative data analysis. We will 
invite senior qualitative researchers to provide coding demonstration, scheduled 
training, and supervision. Several strategies during the data analyses will be used to 
ensure trustworthiness: peer debriefing at regular meetings with the research team, 
persistent weekly observation, and member check. Additionally, triangulating method 
will be used to establish confirmability of the quantitative results. 
4. 
Expected the contribution of the Research  
This study will thoroughly examine the relationship of Paro intervention on the 
change of group interaction and mental health for specific attachment orientation older 
adults with dementia. This is the first study we know of to utilize a rigorous research 
design to examine the effect of intervention and explore the relationship between 
different attachment orientation older people and Paro. The findings of this study will 
provide strong evidence and advance knowledge of the mechanism of group-based Paro 
intervention in LTC of Taiwan and be able to link this result to international studies. 
The findings of the research will publish in international journals. 
5. 
Expected Contribution of Research to Personnel  
There are regular training and interdisciplinary meetings for all research staff to 
strengthen their research skills, as well as expand their knowledge for newly aged care 
model such as innovated technological devices and robots for older adults. The staff 
will conduct research capacity training prior to the study, including questionnaire 
administration, Paro intervention, and data analysis. Research members will recognize 
measurements of cognitive function tools, mental well-being, depression, and 
loneliness distress symptoms and learn how to cooperate with interdisciplinary experts. 
These skills will help members to foster teamwork and interdisciplinary knowledge and 
expand integration of knowledge systems such as nursing, psychological and robotic 
technology. The above training will help members to advance capabilities to be an 
independent research, behavioral observer, and a competent analyzer. 
 
 
 

40 
 
Study 3: 
Effect of the Paro intervention on cognitive, executive functions and mental well-
being for attachment-specific people with dementia – a pilot randomized 
controlled trial 
 
Abstract 
Social robots have been validated as a therapeutic modality to provide stimuli to 
reduce the negative emotions and to improve the quality of life for people with dementia. 
However, existing research pointed out that the effectiveness of social robot (Paro) on 
people with dementia has shown inconsistent results. Previous studies have also found 
that different emotional attachments between human and Paro have shown different 
psychological effects for older adults. However, these conclusions still lack empirical 
research support. Therefore, this study will use a pilot randomized controlled trial to 
examine the effect of Paro intervention on the cognitive, executive function and mental 
health for specific attachment older adults with dementia. A randomized controlled trail, 
single-blind, two parallel groups, and repeated measures design were used to examine 
the effects of Paro intervention on cognition, executive functions, and mental well-
being for specific attachment older adults with dementia at before, during and after the 
intervention. A sample of 120 older adults with dementia who are 65 years or older 
living in long-term care will be invited. Older adults will be randomly assigned to 2 
groups: experimental group or two control group. Sixty older adults will be recruited to 
each group. The outcomes will be assessed based on the change of cognitive, executive 
functions, loneliness, depression, and well-being at baseline, 3rd week during the Paro 
intervention, the end of intervention (6th week), and the 1 month after the Paro 
intervention. A mixed between-within subjects analysis of variance design will be used 
to assess the immediate effects of the 6-week Paro intervention on cognitive, executive 
and three mental well-being related variables for different attachment orientations of 
older adults living LTC facilities. The results of this study will be used to provide 
empirical evidence to identify the effectiveness of Paro intervention on the cognitive, 
executive function and mental well-being for the older people with dementia. These 
results can be promoted as a care model in the long-term facilities in the future. 
 
 

41 
 
I. Method 
1. Aims  
The aims of this study is to examine the effect of the Paro intervention on cognitive, 
executive functions and mental well-being for older people with dementia. 
2. Objectives  
(6) To examine the effect of Paro intervention on cognitive and executive functions 
functions for older people with dementia. 
(7) To examine the effect of Paro intervention on depression for older people with 
dementia. 
(8) To examine the effect of Paro intervention on loneliness for older people with 
dementia. 
(9) To examine the effect of Paro intervention on mental well-being for older people 
with dementia. 
3. Research design 
This is a repeated measures study that is a randomized controlled trail, four parallel 
groups, and single-blind design. It is used to examine the effects of Paro intervention 
on cognition, executive functions, and mental well-being for older adults with dementia 
at before, during and after the intervention. A mixed between-within subjects analysis 
of variance design will be used to assess the immediate effects of the 6-week Paro 
intervention on cognitive, executive and three mental well-being related variables for 
different attachment orientations of older adults living LTC facilities. Outcomes of 
interest measures will include cognitive and executive functions, and depression, 
loneliness, and mental well-being at three time points: before the intervention (T0), 
middle of intervention (week-3, T1), the end of intervention (week-6, T2), and 1 month 
after the intervention (T2). Secondary outcome is interest in the impacts of the Paro 
intervention on psychological outcomes for different attachment style of older adults 
with dementia. The Revised Adult Attachment Scale Chinese version (RAAS-C) will 
be used to classify the attachment types of the elderly. A sub-group analysis will be 
conducted to further understand the changes in the physical and mental health of the 
elderly with different attachment types after receiving Paro intervention. 
The purpose of this study is to examine the effect of Paro intervention on cognitive, 
executive, depression, loneliness, and mental well-being depression and loneliness for 

42 
 
older adults with dementia in LTC. The research design is shown in Table1.  
 
 
Table 1 Research design for Paro intervention 
Group 
T0 
Intervention 
T1 
T2 
T3 
 Experiment 
O1 
X 
O2 
O3 
O4 
 Control 
O1 
 
O2 
O3 
O4 
4. Sample size, Sampling, Settings, and Participants Recruitment  
The same with study 1. 
5. Intervention 
Participants in the experimental group will receive a group (6-8 people as a group) , 
facilitated, and 30-minute weekly session Paro intervention for 6 weeks. The control 
group will receive care as usual activities, such as painting, drawing, and craft, which 
are provided by each facility. 
6. Procedure of interaction records 
Participants in experimental groups will receive a group, facilitated, 30-minute 
weekly session of Paro intervention. A trained research assistant (RA) will give the Paro 
to the participants at the start of each session, repeating the same introductory script 
each time. The RA facilitate the participant interact with the Paro during the 
intervention, after 30 minutes RA will use the same ending script to end the session and 
goodbye to participants.  
7. Outcome measures 
The process and outcome of measurement will be blinded and assessed by another 
RA at four time points: baseline (T0), Week 3(T1), Week 6 (T2), and 1 month after the 
end of intervention(T3). The primary outcomes are global cognitive function and 
executive functions. The Mini-Mental State Examination (MMSE) will be used to 
assess participants’ global cognitive function. The executive functions include two 
components such as working memory (WM) and response inhibition, which will use 
computerized tasks to assess the changes of executive functions for order adults before 
and after intervention. Working memory will be assessed using verbal WM and visuo-
spatial WM tasks. Response inhibition will be assessed employing color word stroop 

43 
 
(CWS), stop signal (SS), and go/no-go (GNO) tasks. The secondary outcome measures 
are loneliness (UCLA version-3), Depression (GDS-SF), and Mental well-being 
(WEMWBS).  
Table 2 Measurement time points and measurements 
Instrument 
Week-0 
(T0) 
Week-3 
(T1) 
Week-6 
(T2) 
Follow-
up 
(T3) 
Demographics/disease 
information 
 
 
 
 
RAAS-C 
 
 
 
 
Outcome measure 
 
 
 
 
-MMSE 
 
 
 
 
-Executive Functions 
 
 
 
 
-Loneliness (UCLA) 
 
 
 
 
-Depression(GDS-SF) 
 
 
 
 
-Mental 
well-being 
(WEMWBS) 
 
 
 
 
Note. , collect data; MMSE; executive function; UCLA, the University of 
California Los Angeles Loneliness Scale version 3; GDS-SF, Geriatric Depression 
Scale - Short Form; WEMWBS, Warwick-Edinburgh Mental Well-being Scale. 
(1) Demographic data 
Participants’ demographics such as age, gender, education level, religion, number 
of children, and previous pet ownership will be collected. Disease-related information 
will include the length of stay in the LTC, type of depressive disorder, any other chronic 
disease, a medication audit including antidepressants and other medications, and 
Barthel index of Activities of Daily Living. 
(2) The Chinese version of Mini-Mental State Examination (MMSE) 
The Mini-Mental State Examination (Folstein, Folstein, & McHugh, 1975) is a 
widely used tool that screens for levels of cognitive impairment, using the concepts of 
orientation, registration, attention and calculation, recall, and language. The MMSE has 
been translated into Chinese with small modifications based on the sociocultural 
differences of the Chinese population, and has been utilised as a dementia screening 
instrument for epidemiological studies (Zhang et al., 1990). The MMSE has good 
internal consistency with a Cronbach alpha of .91 (Marioni, Chatfield, Brayne, & 
Matthews, 2011). In a previous study, the MMSE has shown good sensitivity of 78.4% 
and a specificity of 87.8 % in primary care (Mitchell, 2008). The Cronbach alpha 
was .83 to .84 in older Taiwanese populations (Chung, Chiou, & Chou, 2009; Lou, Dai, 

44 
 
Huang, & Yu, 2007). The MMSE score ranges from 0 to 30. In general, a cut-off point 
higher than 24 indicates normal cognition; 20–23 mild cognitive impairment; 10–19 
moderate cognitive impairment; and 0–9 severe cognitive impairment. In this study, the 
cut-off point was based on a study by Zhang et al. (1990) in which the level of cognitive 
impairment varies according to educational level: 17⁄18 for older people without formal 
education, 20⁄21 for those with 1–6 years of education (primary school), and 24⁄25 for 
participants with more than six years of education (middle school or higher) in Chinese 
older adults. 
(3) Core components of executive functions- WM and response inhibition 
The two core executive functions, WM and inhibition, were assessed using 
computerized tasks. Working memory was assessed using verbal WM and visuo-spatial 
WM tasks. Response inhibition was assessed using CWS, SS and GNG tasks. All older 
adults with dementia will be individually tested in a quiet room. The order of task 
administration is the same for all participants and they will receive a practice session 
prior to all the tasks. A period of rest is given between two tasks. 
Color word Stroop task (Stroop, 1935; Macleod, 1991): In this task different 
colour words will appear on the computer screen one at a time. The task is to name the 
color the word is printed, disregarding what the color word reads. The colour of the 
word printed is in the same color as the meaning of the word (congruent trials, eg; “red” 
is printed in red colour), or it is different from the meaning (incongruent trials, eg; word 
“green” is printed in blue colour). There are 75 congruent trials and 25 incongruent 
trials for one test session. Incorrect responses on incongruent trials are taken to assess 
the level of inhibitory control. The higher the errors the lower the interference control 
is. 
Visuo-spatial WM task: A 4 × 4 matrix with 16 squares is displayed on the 
computer screen as a pig house with a pig appearing in each window one at a time. The 
task is to recall in reverse order the locations where each target (pig) has appeared. The 
test start with a span length of two, that is, two pigs appear one after another. Each span 
consist of two trials and the test is concluded when the participant failed both trials at 
that same span length. Each correct location is given one point with a maximum score 
of 88. The score is taken as the measure of Visuo-spatial WM. At the end of the test, 
obtain score is automatically displayed on the computer screen. 
Stop signal task: It assess the ability to inhibit ongoing responses. This is like a 

45 
 
car game (Tillman, Thorell, Brocki & Bohlin, 2007) where a car appears on the 
computer screen. Every time the car appear, the participant is supposed to press a 
designated key as fast as possible to drive the car away. But when a stop-sign board 
appeared next to the car, participants has to refrain from pressing for the car to stand 
still. Each session in this task consist of 24 trials with six stop-signs-trials. Number of 
incorrect presses in stop sign (commission errors) is considered as the measure of 
inhibition and it is automatically displayed on the screen at the end of the task. 
Verbal WM task (adapted from Towse, Hitch & Hutton, 1998): These are power 
point slides. Each slide has different numbers of red circles with squares as distracters. 
The task is to count the total number of red circles in each slide, keep total in memory 
and recall the numbers in the correct order. The test start with a length of memory recall 
(span) of two, that is, the participant had to recall two slides first. Each level of memory 
recall consist of three trials and the test is concluded when the participant failed two 
trials out of three at that same length of recall. If the participant is successful in 2 out 
of three trials, he/ she is allowed to go to the next span. A total score is calculated after 
adding a mark for each correct recall (Towse, Hitch & Hutton, 1998). 
Go/no-go task (two versions: colour and shape): It assess ability to inhibit pre 
potent responses. The subject is presented with four different stimuli on the screen, one 
at a time in random order. There are two squares and two circles in blue and red. In the 
first session, the subject is instructed to respond by pressing a key each time when a 
blue figure appeared (go-trials) regardless of the shape, and not to respond when a red 
figure appear. In the second session, the subject is instructed to respond each time when 
a square appear, regardless of the color, and not to respond when a circle appear (Berlin 
& Bohlin, 2002). Together the two consecutive sessions include 60 stimuli with 77% 
go-trials. The number of incorrect responses (commission errors) is used as a measure 
of inhibition and it is automatically displayed on the screen at the end of the task. 
(4) The UCLA Loneliness Scale version 3 
The UCLA Loneliness Scale Version 3, a 20-item scale, was developed by Russell 
(1996). It is used to measure a person’s subjective feelings of loneliness and feelings of 
isolation. Each item on the scale is rated from 1 (Never) to 4 (Often) with a total score 
ranging from 20 to 80. The scale does not identify a cut-off score that defines loneliness. 
The higher the score, the more severe a person’s feelings of loneliness. This scale has 
good reliability with Cronbach’s alpha of internal consistency ranging from 0.89 to 0.94 

46 
 
in the original scale (Russell, 1996). Moreover, studies also have established good 
reliability when using UCLA Loneliness with older adults in LTC facilities with a 
Cronbach alpha ranging from 0.86 to 0.90 (Adams et al., 2004; Bergman-Evans, 2004; 
Hawthorne et al., 2008).  
The UCLA Loneliness has been translated into Chinese by Zhang and Yang (1999) 
who has completed the evaluation of the content validity with CVI of .85. Regarding 
reliability, the Cronbach’s α is measured by the elderly is between .82 and .89. The 
internal consistency for the UCLA Loneliness was acceptable with Cronbach’s α of 
ranging from .82 to .89, which can be used in Taiwanese older adults. 
(5) Geriatric Depression Scale - Short Form (GDS-SF) 
The GDS-SF, developed by Yesavage and Sheikh (1986), consists of 15 items with 
10 positive items and 5 negative items. GDS-SF has been found to be a useful tool to 
detect depressive symptoms in older populations (Greenberg, 2007). Each item has a 
yes or no answer response, and one point is scored for each bolded answer selected. 
The scores range from 0–21 and a cut-off point of 6 or more indicates the presence of 
depression (Chan, 1996). The sensitivity and specificity of the original scale were 84% 
and 95%, respectively (Yesavage & Sheikh, 1986). 
This scale has good reliability with Cronbach’s α of internal consistency with 0.89 
in the original version and 0.81 in the Chinese version. Wang (2001) measured the 
depression of older adults in Taiwan by the GDS-SF. 
(6) Warwick-Edinburgh Mental Well-being Scale (WEMWBS) 
The WEMWBS scale was developed by researchers at the Universities of 
Warwick and Edinburgh (2006), including 14 items of mental well-being covering 
subjective well-being and psychological functioning. The scale is scored by summing 
responses to each item answered on a 5 points Likert scale and the scores range from 
14 – 70. The higher the score, the better the mental well-being. This original scale has 
good reliability with Cronbach’s alpha of internal consistency with 0.89, test-retest 
reliability with .83. 
The Chinese version of WEMWBS was used in community-dwelling elderly by 
Liu, Guo and Liu (2016) with Cronbach’s α = .93 and test-retest reliability of .79. 
Therefore, we will further examine the reliability and validity of the Chinese version of 
WEMWBS for older adults in Taiwan. 

47 
 
8. 
Data analysis 
Data will be analyzed using the Statistical Package for Social Science (SPSS) for 
Windows software version 26 (IBM Corp.). Data collected will be reviewed for 
completeness and consistency within a single data form. Approximately 10% of the 
data entry will be checked for accuracy and consistency (Gad & Taulbee, 1996). Last 
observation carried forward method will be used to manage missing data at random 
(Kang, 2013). An intention-to-treat approach (Gupta, 2011) will be used in which all 
participants will be analyzed according to their enrolment.  
Descriptive statistics will be used to analyses demographic data where normality 
of data distribution for the outcome variables will be examined using probability plots 
and Kolmorgorov-Smironov tests. Frequency and percentages will be used to 
summarize categorical variables such as gender and educational level. Mean, standard 
deviation, and range will be reported to present continuous variables such as age and 
the score of all scales. Demographic characteristics and baseline data of participants 
will be compared with different subgroups, using chi-square for categorical variables 
or t-test (or Mann-Whitney U test) for continuous variables. Relationships between 
demographic characteristics and outcome measures will be explored using Pearson’s 
correlations. Cronbach’s alpha will be used to check the reliability of all instruments. 
To probing the change of the markers, a series of paired sample t-test will be used 
for each group. To testing the research hypothesis, a mixed designed generalized linear 
model (GLM) will be employed to test the effects of arms on the differences between 
the pre and post-test in relation to outcome measures, including oxytocin level, 
dopamine and HRV changes for different attachment orientations of older adults living 
LTC facilities. In order to increase precision in estimating the effect of interest, the 
possible confounding effects of the covariates, such as age, education, etc, will be used 
to take into account as covariate in the model. The effect size will be calculate to show 
the magnitude and direction of the effect in the attachment-specific group relative to 
the control for each outcome variable. In order to identify the optimal duration of 
clinical application for this intervention, a trend analysis will be conducted. Explorary 
additional analysis will be conducted to test the interaction between intervention, and 
potential biomarker on clinical evaluation. A p value < .05 will be taken as the level of 
statistical significance. The 95% confidence interval around the differences will be 
calculated. 

48 
 
II. Expectation Outcome 
We expect to identify positive effect of Paro intervention on cognitive, executive 
functions, depression, loneliness, and mental well-being for older adults with dementia. 
III. Ethical Considerations 
Ethics approval for both phases of the study will be sought from Cheng-Kung 
University Human Research Ethics Committee and prior to the commencement of the 
study. Ethics approval for the study will also be sought from the participating LTC 
facilities in Taiwan prior to the commencement of the study. The researcher will inform 
the participants about the aims and objectives of the research study and what their 
participation will involve. Participants will be assured that (a) their participation will 
be on a voluntary basis and they are under no obligation to participate; and (b) they are 
free to withdraw from the study at any time without explanation, penalty or 
compromising their relationship with the LTC. A signed consent form will be sought 
from each participant. There are no foreseeable risks associated with participation in 
the intervention for participants. 
All collected data will be stored electronically with password-protection to prevent 
unauthorised access to the data. All data and related documents will be kept in a key-
locked cabinet for 5 years before being destroyed. Although demographic data will be 
requested, participants will remain anonymous. For quantitative data, all data will be 
de-identified at data entry and results will be reported in general terms. For qualitative 
data, the digital interview files will be deleted after transcription. Data will be de-
identified with codes and content separated. Anonymity will be maintained via 
pseudonyms for direct interview quotes used in the reporting of findings.  
For ethical consideration, our research team will provide opportunity for the 
elderly in the control group who receiving plush toy. They can choose to partake two 
50-minute sessions of group-based Paro interventions to experience interactions with 
Paro after completing their intervention and follow up. 
IV. Expected difficulties encountered and solutions 
1. Difficulties for participant’s recruitment and active engagement data 
collection 
This study will conduct 6 weekly sessions of Paro intervention in LTC facilities. 
Older adults may feel anxious about interaction with a Paro or withdraw from the 

49 
 
intervention. For dealing with this potential problem, the possible solutions are as below: 
(1) The research team will hold a briefing to explain the research process to the 
participating institutions in order to attract the participation of the heads of the 
institutions. 
(2) Introducing the Paro to family and encourage family and workers interacting with 
the Paro. Also, encouraging participants share their experiences with his/her 
friends.  
(3) Provide incentives or motives for participants and explaining the research 
procedure and potential benefits for them. The research team will show a Paro 
video or demonstrate Paro interaction to participants and facilities to introduce 
how the Paro interact with other older adults and share with experiences to using 
it.  
2. Difficulties in quality assurance and quality control in Paro research 
As a limited number of Paro, each round will plan to recruit 6 participants. The 
research team will extend the study periods to recruit enough participants. For 
controlling the research quality, the possible solutions are as below: 
(1) 
To increase the quality and consistency of interaction with Paro. Each facility 
will recruit two volunteering care staff to participate in the study. Staff will 
receive 1 hour of Paro interactive training. Each care staff will provide 
incentives and motives to increase motivation to partake this study. 
(2) 
For reducing the interference or contamination among the four groups. This 
study will recruit control group and experimental groups in different levels to 
prevent interference among groups receiving intervention at the same time in 
the same facility. 
(3) 
To reduce the human interferences. In order to establish a research consensus 
among institutional staff, we will provide a 60-minute course to workers in 
participating facilities, the purpose of which is to help them to familiarize with 
our programs and procedures  
 
1. 
Work Projects 
(1) Contact with the long-term care facilities and design a flyer for recruitment 
of research participants. 

50 
 
(2) Research assistants training, establishing standardized procedures of 
intervention, developing data collection steps, related knowledge of 
processes in Paro intervention. 
(3) For research fidelity, monitoring experimental group and control group by 
weekly check, holding regular steering meetings to maintain the quality and 
consistency of program implementation. 
(4) Conduct data collection using questionnaires. 
(5) To submit the manuscript to international conferences and health-related 
journals. 
(6) To submit the final report for the project. 
2. 
Expected the contribution of the Research  
This study will thoroughly examine the effect of Paro intervention on cognitive, 
executive functions, mental well-being for specific attachment orientation older adults 
with dementia. This is the first study we know of to utilize a rigorous research design 
to examine the effect of intervention and explore the relationship between different 
attachment orientation older people and Paro. The findings of this study will provide 
strong evidence and advance knowledge of the mechanism of Paro intervention in LTC 
of Taiwan and be able to link this result to international studies. The findings of the 
research will publish in international journals. 
3. 
Expected Contribution of Research to Personnel  
There are regular training and interdisciplinary meetings for all research staff to 
strengthen their research skills, as well as expand their knowledge for newly aged care 
model such as innovated technological devices and robots for older adults. The staff 
will conduct research capacity training prior to the study, including questionnaire 
administration, Paro intervention, and data analysis. Research members will recognize 
measurements of cognitive function tools, mental well-being, depression, and 
loneliness distress symptoms and learn how to cooperate with interdisciplinary experts. 
These skills will help members to foster teamwork and interdisciplinary knowledge and 
expand integration of knowledge systems such as nursing, psychological and robotic 
technology. The above training will help members to advance capabilities to be an 
independent research, behavioral observer, and a competent analyzer. 

51 
 
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