Clinical trial · Interventional
Effect of the Group-based Paro Intervention on Physiological and Psychological Outcomes
National Tainan Junior College of Nursing
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Impairment | — | UNRESOLVED | — |
| Dementia, Mild | — | UNRESOLVED | — |
| Dementia Moderate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paro (social robot) intervention | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Paro intervention group
- description
- 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.
- interventionNames
- Device: Paro (social robot) intervention
- type
- NO_INTERVENTION
- label
- control group
- description
- The control group will receive care as usual activities, such as painting, drawing, and craft, which are provided by each facility.
Primary outcomes (13)
- measure
- Oxytocin
- timeFrame
- Change from Baseline Oxytocin at 6 weeks
- description
- Blood samples for the oxytocin assay will collected from the antecubital vein into pre-chilled 5 ml EDTA tubes with 250 KIU of apoprotinin, and refrigerated until processing.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available