NCT05102201

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

National Tainan Junior College of Nursing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: National Tainan Junior College of Nursing · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Dementia, Mild
• Dementia Moderate
• Cognitive Impairment

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2022-03-22
• Primary completion: 2022-05-24
• Completion: 2022-05-30
• First posted: 2021-11-01
• Last updated: 2022-09-28

Locations

1 site across 1 country: Taiwan