Effect of the Group-based Paro Intervention on Physiological and Psychological Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-22

Study Completion Date

2022-05-30

Brief Summary

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This project contains three studies. This study will use a pilot randomized controlled trial to examine the effect of Paro (social robot) intervention on oxytocin, dopamine, and HRV variations and mental well-being for specific attachment older adults with dementia. A randomized controlled trial, single-blind, two parallel groups, and repeated measures design were used to examine the effects of Paro intervention on neurobiologically changes and mental well-being for specific attachment older adults with dementia before, during, and after the intervention.

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Detailed Description

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This project contains three studies. Study 1 will use a randomized controlled trial to examine the effect of Paro (social robot) intervention on oxytocin, dopamine, and HRV variations for specific attachment older adults with dementia. A randomized controlled trial, 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 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 older people with dementia. These results can be promoted as a care model in long-term facilities in the future.

Conditions

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Dementia, Mild Dementia Moderate Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled trail, single-blind, two parallel groups, and repeated measures design

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Allocation to treatment groups was concealed from participants until it was operationally required to begin intervention activities (ie, postbaseline data collection). Research assistants involved in data collection and data coding were masked to the other intervention groups through assignment of work to 1 group only, and by separate working locations. Intervention RAs were allocated to specific facilities, working with only one of the groups, and were masked to all outcome measurements, as were participants.

Study Groups

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Paro intervention group

Participants in the Paro intervention group will receive a group (6-8 people as a group), facilitated, and 30-minute weekly session Paro intervention for 6 weeks.

Group Type EXPERIMENTAL

Paro (social robot) intervention

Intervention Type DEVICE

Participants in the Paro group will receive a group (6-8 people as a group), facilitated, and 30-minute weekly session Paro intervention for 6 weeks

control group

The control group will receive care as usual activities, such as painting, drawing, and craft, which are provided by each facility.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Paro (social robot) intervention

Participants in the Paro group will receive a group (6-8 people as a group), facilitated, and 30-minute weekly session Paro intervention for 6 weeks

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

(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

Exclusion Criteria

(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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No